Mentor MemoryGel Silicone Breast Implants:

Scroll down for a list of symptoms women have reported to the FDA and for reports of mastectomy and reconstruction cases, fungus, body parts removed, manufacturer issues, BIA-ALCL, other cancers, and pre and post approval study follow-up.

FDA Documents:

2019 Update – FDA Issues Warning Letter to Mentor: 

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19)

“We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies.” – FDA Commissioner Scott Gottlieb, M.D.

“Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.”

FDA’s warning letter to Mentor Worldwide LLC (Mentor)

Mentor’s MemoryGel Post-Approval Studies (6):

These were conditions of FDA approval and were required by the Approval Order.

1. Large Study: The follow-up rate was 20.1% at 7 years and the final report is on year 9 in 2015. The FDA had required this study to be done for 10 years. This study was revised/replaced into small cohort studies on 10/01/2014.

2. Core Study: The follow-up rate was 62% at 10 years. The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Report was submitted in year 6 of the study in 2012.

3. Adjunct Study: The follow-up rate was 13.8% after 5 years. Adjunct studies are the premarket studies integrated into the post-approval studies so that the pre-market enrolled patients can complete their five year follow-up.

4. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. Some respondents suggested that the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery.

5. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent.

6. Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. These were requirements of the Approval Order.

“Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.” – FDA

In 2011 there was an update on the findings (Update on the Safety of Silicone Gel-Filled Breast Implants).

In 2013, American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding.

From 2014-2015, some studies (e.g. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Case-control studies were later terminated after the release of Tufts’s evidence report.

Case-Control Study: Terminated. The purpose was to evaluate the association between Mentor MemoryShape Silicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. This study was to be conducted in Denmark, Germany, and the UK.

MemoryShape and MemoryGel Post-Approval Study: Intended to follow women for 10 years, commencing in 2013. This study will combine MemoryShape and MemoryGel patient results.

Re-Op Study: This study will collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation.

If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for the Post-Approval Studies program. Her email is [email protected] and phone number is (301) 796-6134.

FDA MAUDE – Adverse Reaction Reports for 2017 –  Inclusive of Mentor Silicone Breast Implants:

I had silicone breast implants from mentor in 2013. Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. Link.

I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. I have hot and cold sensitivities. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. Link.

Hair loss and dryness, skin dryness and itchiness, dry, brittle flaky nails, extreme sensitivity to cold, night sweat, depression (feeling like the world would be better without me in it), and anxiety. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. Ringing in ears, metalic taste in mouth, skin rashes – bug bites, scratches and other wounds take forever to heal. Weight gain, heavy and abnormal menstrual cycles, heart palpitations, chronic diarrhea, muscle cramping/frequent charlie horses, frequent swollen and sore lymph nodes – usually under arms sometimes neck, sensitive eyes, enlarged thyroid, allergies for the first time in my life, pain where the ribs meet the sternum. Link.

Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. Link.

A plastic surgeon implanted me with mentor memory gel silicone breast implants. I started becoming ill after a few months. I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities. Link.

I had a breast augmentation on (b)(6) 2015. Since that day i’ve suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. As time continues to pass, more symptoms seem to be showing up. Link.

Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Right implant capsulated and became painful. C reactive protein is measuring 48 or higher. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. The list goes on. Link.

I had breast implants on (b)(6) 2016. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. Implants robbed me of a year of my life!. Link.

I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. Anaphylactic symptoms. Memory problems, disturbing enough to affect me emotionally as well. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Hair thinning and lost. Muscle pains and joints. Implants are poisonous. Link.

Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue. Link.

Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. Tingling in hands and feet, temperatures problems, depression, confusion. Link.

I began having rheumatoid symptoms – inflammation, huge knots popping up in various joints, pain on level 10. Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year. Link.

I have been ill since having silicone implants – fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. I have had 5 surgeries for shoulders and 2 on my hands. After having the breast implants removed on (b)(6) all the pain and disorders are gone. Link.

Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). Shortness of breath (feel like i can’t catch my breath). Constant lower back pain (and right hip). Extreme smell sensitivity and intolerance of foods i used to eat. Difficulty healing (wound etc. ) dizziness (light headedness). Link.

Hair was falling out, constantly getting sick with sinus issues – cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. Have had multiple visits to the ent and walk in clinic. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness – 1 side. Going to dermatologist in a week to check extreme perioral dermatitis. Smooth mpp gel mammary prosthesis. Link.

Have mentor breast implants. Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability. Link.

I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. I’ve been sick ever since. No doctor can help me and i fully believe it’s the breast implants making me ill. I have constant infections. Shooting and sharp pain in the breasts. I have arthritis and thyroid issues. It’s never been ending and i can’t get medical assistance to have them removed. Link.

Mentor silicone implants caused a slew of health issues. I just explained and am getting my health back. Lived with 20+ symptoms for over 5 years. I immediately felt relief in my joints and muscles as soon as they were removed. Link.

I had silicone breast implant and for years had every test there is to find out what was wrong with me. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimoto’s along with just guesses of what could be wrong. I explanted 3 weeks ago and all my pain is gone. I still have severe ringing in my ear that hasn’t left. Something needs to happen you have dropped the ball on this. So many women are sick and get better after explant. Research needs to be done. Link.

This is not a one time event, but this was the beginning of many different health issues i had. I got severe spinning vertigo that lasted 6 years. Along with that were 35 other symptoms. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. Link.

On (b)(6) 2015 i had woke up to a horrible pain, ended up capsular contracture grade 4 (baker), then ended up ruptured right breast tissue and implant as well as the following: fatigue or chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss), muscle aches, pain, and weakness, joint pain and soreness, hair loss, dry skin, eyes, mouth, hair, weight gain or weight loss, easy bruising and slow healing of wounds, temperature intolerance, low libido, ringing in the ears, heart palpitations, photosensitivity, shortness of breath, metallic taste in the mouth, oral thrush (white tongue), night sweats, skin rashes, insomnia, estrogen/progesterone imbalance or diminishing hormones, swollen and tender lymph nodes in the breast area, underarms, throat, neck, or groin, tingling or numbness in the arms and legs, burning pain around the chest wall or breasts, cold and discolored hands and feet, foul body odor, muscle twitching, dehydration, frequent urination, chronic neck and back pain, nail changes (cracking, splitting, slow growth, etc), skin freckling, pigmentation changes (darkening or white spots), or an increase in papules (flesh colored raised bumps), edema (swelling) around eyes, premature aging, decline in vision or vision disturbances, liver and kidney dysfunction, digestive and gastrointestinal issues, food intolerances and allergies, smell or chemical sensitivities, new or persistent infections – viral, bacterial, and fungal (candida), reoccurring sinus infections, throat clearing, cough, difficult swallowing, choking feeling, chronic inflammation, feeling like you are dying, headaches, dizziness and migraines, mood swings, emotional instability, anxiety, panic attacks, suicidal thoughts, depression, hypo/hyper thyroid symptoms, hypo/hyper adrenal symptoms, symptoms or diagnosis of fibromyalgia, symptoms or diagnosis of lyme, common autoimmune disease, 33 different metals and chemicals including silicone. These are mentor memory gell 450cc breast implants still in me. Link.

Had breast implants put in and have had failing health since. Just came across the breast implant illness. Link.

Had mammogram at (b)(6) hospital and became very ill within 3 weeks. I had silicone breast implants and had no idea they both got ruptured. I started in (b)(6) going to doctor. Unable to walk. Severe pain in feet. Many test to follow. Was sent to podiatrist and rheumatologist. Was immediately put on meloxicam for inflammation. Tested positive ana for possible lupus. Had many blood test and i have all of the results. As of(b)(6) i no longer was able to work. Diagnosed with mid foot osteoarthritis and surgery was suggested. I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. I applied for social security disability and as approved. I did not correlate the breast implants till approx (b)(6). I requested an mri and it was shown both implants were ruptured. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. I got so sick so fast and did not know why. Since the removal of the implants, i have had 2 add’l reconstruction surgeries including a latissimus flap. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. I have pictures, notes and many bills. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. The implants were silicone made by mentor 600cc. Link.

It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants. Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression. The patient also reported breast pain which appeared in 2016 along with lump in her breast. Mri confirmed that the breast implant had ruptured. In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. Link.

I had mentor silicone breast implants in (b)(6) 2007. For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. I have been to several doctors and specialists over the year with no help or definite answers. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. I am researching that option now. Link.

Mentor textured silicone gel implants. Caused autoimmune diseases ana connective tissue diseases. Currently, diagnosed systemic lupus. Link.

Believe my silicone breast implant was ruptured after a mammogram. Link.

Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. It behave with extreme fatigue and has increasingly gotten worse. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. Extreme vitamin d deficiency. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. Dry eyes, blurred vision, double vision, and eye pressure. Dry hair, dry skin, dry mouth, and dry nails. Migraine headaches, depression, heart palpitations, nausea, and anxiety. Mastitis, cellulitis of the breast. Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. Extreme hair loss that has created balding (alopecia) on my scalp. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). Loss of appetite, weight loss. Metalic taste in my mouth. Ringing in my ears daily. Muffled ears like swimmers ear. Neck, shoulder pain along with tension on where my head and spine meet. Bruise easily. Knee/joint pain. Night sweats. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and i’m barely in the normal range. Weekly b12 injections. Panic attacks, chest pain, breast pain, inflammation, depression. Loss of interest and pleasure in doing activities. Link.

I had mentor cohesive gel implants placed. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. Also. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. I also developed severe reactions to some foods. Link.

It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. Patient also had developed rashes and pruritis. Dermatologist and allergist were seen without relief. The patient sought treatment from several physicians, who concluded that the implants were responsible for patient¿s condition. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. Pathological evaluation of the patient¿s lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses. Link.

Over time since implants. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. Link.

It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011. The patient felt discomfort which she had not previously experienced. After approximately 1. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Patient took advil, various muscle relaxants, heat and other remedies. Patient was diagnosed with left implant rupture around (b)(6) 2015 and got implant removed on (b)(6) 2015. Patient felt symptom-free almost immediately after removing implants. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. Link.

I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. Less than 6 months after having these implants, i started to develop multiple symptoms. It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. In doing my research, i trusted the fdas recommendation that these were very safe implants. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. I researched and found tan excellent plastic surgeon. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. I believed the fda and the plastic surgeon. I have followed every recommendation that has been made in regards to the breast augmentation surgery. I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. Important information: i have been very diligent in following doctor’s protocols and have preferred diet and exercise over medication if at all possible. I do not smoke cigarettes, and rarely ever drink any alcohol. In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. Link.

I will be having my silicone implants removed. After several years of pain and discomfort and being diagnosed with sjogren’s syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing. The implants are scheduled to be removed on (b)(6). Other diagnosis are for fibromyalgia due to the chronic pain i suffer. Link.

I had mentor silicone implants in 2012. I was in a car accident in 2014. Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. I had a 3-d mammogram and everything looked fine. I was convinced that the implants had ruptured even though it didn’t show up. I had them taken out. Both of the implants had holes. I am convinced that all of my problems stemmed from the holes in them. I was fine for the first two years. Link.

My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. I asked doctors if it could be my implant and they told me, “no. The fda say they are safe. ” waiting for scheduled explant and lymphadenotomy when i will be hospitalized. In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, won’t travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. Only need to get an mri if you suspect a rupture or feel contracture. I’m disappointed that the fda allowed mentor to complete their own studies and so easily allowed them back on the market after only 3 years so that this implant company and plastic surgeons could make money. This is five years of my life i can’t get back. Five years of being sick. Five years of medicating my body when it was trying to say please get these out of me. Please take these off the market. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they don’t treat it right away. I know many, many(over (b)(6)) women suffering with this same situation. Link.

After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation. Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilbert’s syndrome. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. I was a very healthy, active person up until all of this happened. At the time year mark of getting implants, after being diagnosed with all of these issues, i saw multiple doctors and kept telling them i have a concern it was my implants making me sick. None of them would even acknowledge it because they said “all implants are fda approved” and then would change the subject. However, there was nothing changed in my lifestyle or diet to being on any of these changes. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. I am disgusted how they use the fda as a scapegoat to dismiss women’s health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a women’s body. Not every women is genetically the same and there are many that will not be able to tolerate the implants. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. I am carefully monitoring my progress but something needs to be done about this as i am one of thousands upon thousands of women who have all had this same problem. I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. I am only (b)(6) and should not have any of these health issues. Link.

I do not know the exact dates off hand. However i had in 2010 began to be diagnosed with many more autoimmune disorders. Rheumatoid arthritis sjogren’s barrett’s esophagus with hiatal hernia achalasia, hypertensive les graves disease, severe brain god, severe back pain and behind my left breast, and the worst one of all is this yuck that is trapped in my throat that many women from the breast implant illness site seem to have but mine is extreme i cough up lots of mucus and it’s debilitating. I believe since i already had autoimmune disorders i should have never had silicone implants. I was diagnosed with ulcerative colitis back in 1986 since i’ve had the saline implants removed and silicone replaced them, i have been extremely ill and never once did a doctor suggest it could have been for my implants. I believe as i stated before they have exacerbated my autoimmune challenges. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. The fatigue is devastating. I don’t even know how to put it in words. I am hoping i will get better after explanting. I know many women do whether they have had autoimmune illness before or not! i have been so sick i feel like i have to try getting them out to see if i have a chance to get some sort of my life back. Important information: i have continued to get sicker and sicker and sicker without answers with this “yuck” that i’m dealing with. I am already disabled and with this in addition it’s just too much i am devastated. This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and it’s exhausting. I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i don’t realize it was causing me to feel like i was choking even more. Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. I have gone through all my savings trying to get better! i plan to find out what all i need to take to detox and try to get all this silicone out of my system! it looks like that’s what i am coughing up sometimes like i said it’s extremely sticky. Link.

On (b)(6) 2009 is the date i had surgery to have implants. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Over time, the number of health concerns increased or became increasingly worse. Over the past 3-4 years, the intensity of issues has become severe. Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. These issues impact daily. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. Another said i was “an interesting case” as tests for memory mostly showed fairly bad short term memory. Mris of brain to check for memory related causes were inconclusive. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. Pain is intense, particularly in the mornings or after sitting for a while. Fatigue was addressed with a suggestion to get more sleep. Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). Hugs hurt. Skin issues were addressed with various creams/meds, none which resulted in improvement. Link.

Approx 7 years ago, i had a breast augmentation done, re-done actually. I went from saline smooth implants to textured cohesive gel implants. Within a matter of months, i was already having problems with them the right breast became hard and it wasn’t until this year that i had the funds to have them removed. During the last few years, i’ve had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. Now that i’ve seen the reports on tv and the studies associating silicone implants with a certain type of cancer. I was wondering what steps to take to ensure that i was healthy and safe. I’ve been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. Link.

Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldn’t touch my body. Sensitivity to heat, sunlight and florescent lighting. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldn’t wake up. Difficulty sleeping. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. Team of doctors at (b)(6) clinic couldn’t figure out what was happening to me. Complex case, a lot going on and they couldn’t treat me successfully. Told me to go to (b)(46 clinic. I felt like i was dying. Could barely walk. Tingling and numbness in face, hands, and feet. Burning red rash on my eyelids. Redness all over my body. Auto immune disease, hands were swollen, red, and itchy. Feet red swollen to deformity. Can’t wear socks or shoes only flip flops. I have had blood tests urine testing, ct scans, mris, and neurological testing. I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick. I was systemic. Very weak, couldn’t walk a flight of stairs. I couldn’t breathe, thought i have heart attack. Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3. My body couldn’t sweat couldn’t get rid of toxins. Medtronic and adrenal issues. Link.

Had breast augmentation in (b)(6) 2013. I was implanted with mentor memory gel silicone breast implants. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all that’s happened. Now i am homeless. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. Link.

I had smooth mentor memorygel breast implants placed under the muscle 2. 5 years ago. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. My last hope was to check these out via breast mri. There i saw my right implant was completely ruptured. I have had no trauma or anything to cause such a rupture, especially after having the implants for such a short period of time. They are supposed to last 10 years. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. There are 20,000 of us there with the same stories. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. After that, i developed pneumonia. This has been a terrible month and year for me. My medical bills from this are near (b)(6) and it’s just not right. These devices are not safe. Link.

I have mentor cohesive gel breast implants and experienced symptoms almost immediately. They continue to get worse. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. Rheumatologist said i am at high risk for lymphoma. I have chronic widespread pain and digestive trouble. Severe food, drink and chemical sensitivity. I was healthy and active prior to breast implants. Link.

On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). As soon as 4 months after implantation i had an emergent visit to the er for “vertigo” persistent vomiting and dizziness. Over the next 3 years my health steadily declined with unexplained symptoms. Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. As time went on symptoms worsened with high blood pressure headaches with vomiting more frequent causing me to miss work excessive thirst, urinary urgency and changes in menstrual cycle neck pain. Up until getting implants i never had any significant health problems. I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. After doing research on my own and some common sense. I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimoto’s thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. A lot of my symptoms have improved or disappeared after removing the implants. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. I was told these implants were inert and safe for implantation and that was clearly not the case for me. Link.

Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. I had an mri and confirmed i had ruptured my implant. I have no clue when or how i did this. My implants were under warranty so mentor paid for a new set and most of the surgery. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. So, i had the surgery to replace them and it was an absolute breeze! it was a walk in the park! a few months later things went downhill fast! i was confronted with a whole host of issues- developed hypothyroidism, adrenal fatigue, hormonal imbalance, irregular periods, candida, 15lb weight gain, fatigue, constant pain in my chest (especially on the rt side), all over muscle soreness, joint pain, hair loss, hair texture changes, strange rashes, heavy legs and swelling, low body temperature, skin elasticity changes, cellulite, muscle loss, brain fog, more food allergies, ibs, and a few vitamin deficiencies. The changes i have had in my body in the past 15 months have been so drastic for me. I have seen 10 doctors over the past 3 years and i have been able to “manage,” but most of my symptoms remain at large. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. So, i began my research for answers. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. I am the poster child of healthy. I am as active as i possibly can be, but lately it has become hard- i am always tired! i am certain my breast implants are causing all of my health issues. Link.

It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. Patient presented with bilateral implant rupture. She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimoto¿s disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). Patient was bedridden. She had breast asymmetry on the right side. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Dense breast tissue was confirmed by ultrasound. Patient had implants explanted on (b)(6) 2016. No further information was obtained. Link.

It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. Patient suffered pain on the left side for the past year and it was getting worse. She also had memory problems, fogginess, tinnitus on the left side, headache, joint pain, cold. Her face started to swell when she got cold. Patient was scheduled to have mri exam later. No further information was available. No reports of rupture or other product issues. Link.

Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Worsened over a period of 5-7 years post implant. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. Epidurals and physical therapy for years. Only improvement with prednisone. No improvement with nsaids (multiple tried). Developed anxiety and uncontrolled vaso-vagal responses. Link.

I received my first set of implants in 2005. They were smooth, round, and saline, 270 on one side and 300 on the other. I started having serious difficulty breathing at all times, and especially when laying down at night. I could not get a deep breath. My pcp checked all labs and my heart and lungs and everything was normal. This felt like something physical. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). Finally, i developed a goiter and a high cortisol level. I had the implants removed at the end of 2015. Immediately, my breathing was cured! i no longer had shortness of breath. I know it was the implants pushing on my chest, probably due to the capsular contraction. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. They were very ripply as well. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. I also thought maybe i wouldn’t have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). Immediately and every day since my surgery 3 weeks ago, i’ve had all of the same symptoms reappeared but even worse. I even developed (b)(6) 3 weeks after the surgery under my armpit, which i’ve never had. I haven’t even had a cold for at least 2 years or more. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. There should be some kind of warning about the dangers of breast implants. I’ve been reading endless stories online. Implants should be taken off the market, they are so hazardous to our health. I even contacted mentor and the fda via email before and neither seemed to care. So i am reporting my situation. All i want is for my original breasts to look normal and not have the muscle flex deformity. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that it’s not pulling the breast tissue when i flex. What is your recommendation? my first ones were removed via the area incision and now i have an incision in the inframammary location. Do you think that made a difference in the muscle deformity? i’m so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. I feel my breasts are ruined forever now. At this point, though, i really just want to feel healthy again and get these toxic bags out!. Link.

I had silicone gel breast implants placed under the muscle. Since that date my health has steadily declined with a fast decline noted after 2. 5 post implants. I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants. I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month. Link.

After getting breast implant in (b)(6) 2013, i had hives that lasted a year. In 2014 i started to get swelling in my fingers and toes. The swelling comes and goes. I developed raynaud’s syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. I have ulcers on my fingers that will not heal. Link.

Due to having a birth defect i got mentor gel silicone breast implants in 2008. The new ones that suppose to be fda approved and safe ones. Wrong! they have slowly been poisoning my body. I have a lot of health issues because of them. Blurry vision, memory fog, fatigue, numbness in hand and feet, joint pain, urine retention, trouble concentrating, weight gain, ringing in my ears, anxiety, skin rashes, sleep problems, fungus on my rt toe that will not go away and i keep loosing my toe nail. Shoulder and neck pain, pain under my rt rib. I struggle everyday to do things and plan to explant soon. Link.

Mastectomy and Reconstruction Cases: 

I had to have a double mastectomy in 2009 with immediate breast implants. I have been extremely sick about 1 year after surgery. I am getting sicker and sicker. I have called the surgeon that performed the surgery to get in for check up. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. I have not been followed up with after my last post-up appointment in 2010. I have 3 children and i’m extremely scared that i’m going to die from this illness. Please help me before i lose my life. Link.

Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. After breast cancer reconstruction. Link.

Mastectomy reconstruction revision for deformed reconstructed left breast. Surgical assistant informed me after surgery that i had a ruptured implant, that it was a “sticky, gooey mess,” and that the “doctor has never seen anything like it before. ” Link.

In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. My first symptoms in early 2000 with migraines. Then depression and daily anxiety became an issue. I have been on prescription medications for those. Around 2005, i started having raynaud’s disease which always affects my nipple and toes when cold. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. Link.

I have mentor breast implants for reconstruction from cancer 2015. In a matter of 48 hours – one breast swelled and i went to see my plastic surgeon. Link.

I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. In the past few years i have been suffering from extreme pain in my right breast. Sometimes can’t even have a bra touch it. I have been having vision problems, extreme fatigue, muscle pain, back and neck pain, hearing problems, foggy brain, stomach and intestinal issues, sore throat and can’t swallow, swelling in joints and distorted looking breasts. Link.

My situation was as such: in (b)(6) 2015 after being diagnosed with ductal carcinoma in situ (dcis) for a third time in 12 years, i had a mastectomy with immediate reconstruction on my right side, with a mentor gel-filled implant. Within two months of my operation, i had an odd perspiration odor which remained with me permanently. In the spring of 2016, i began feeling tired after my gym workouts, quite unusual as i had always exercised regularly, and i was in perfect health. By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. I then began to have swollen fingers, hands and wrists in (b)(6) of the same year, which led to my being diagnosed with carpel tunnel syndrome by a rheumatologist. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. I was shocked as nothing like this was ever heard of in my family. I come from a long line of healthy people who mostly live into their nineties. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. I was in extreme pain, and i began losing my hair. I couldn¿t think clearly, and i could not sleep. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. I had upper back and neck weakness. I could not raise my arms, move my legs or use my hands. All symptoms started on the right side of my body, and were more severe than on the left side of my body. When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, ¿you are right to mention this to me. Autoimmune diseases are often caused by external reasons, and are not always hereditary. ¿ in this way, she confirmed that it could be breast implant illness that i was suffering from. The next day, my plastic surgeon agreed to explant my mentor gel-filled implant stating that he could not guarantee that the implant was causing my debilitation and that i might not regain my health. The surgery was on a thursday morning, and i needed a wheelchair by this time. However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. I was able to have a visiting nun come once a week also. It is now (b)(6) 2017 and i am able to walk again. I will continue to receive services from the occupational therapist and the social worker. My physical therapist told me i must maintain an exercise program that he prescribed for me. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. I continue to have swelling in my hands and weakness in my upper arms, neck and back. It is quite difficult to believe that the mentor gel-filled implant was leeching or bleeding toxins into my body to the extent that i was totally debilitated for over 10 months of my life. I thank the rheumatologist for validating the fact that the implant could be the cause. I have been on a detox diet since (b)(6) 2016. I was unable to leave my house unaided from (b)(6) due to this illness. I only left the house for doctor appointments. I could not take myself to these appointments. At present, i cannot sit for long, tire easily and cannot drive far. My upper body muscles ache, and i continue to have difficulty sleeping. I continue with occupational therapy sessions. Link.

Fungus with Mentor Silicone Implants: 

It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. She experienced breast asymmetry (the right breast was lower than the left breast) on (b)(6) 2011, so the patient underwent a revision procedure on (b)(6) 2017 in (b)(6). During this procedure, the surgeon noted that the right breast was discolored (brown). Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement. The patient believes that the discoloration is a fungus growth inside the right device. Per patient, the physician believes the right device was defective. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. Physician did not perform any pathology tests. The left device was not discolored. No deflation were found on both devices. Link.

It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. The product was a silicone gel breast implant. The patient reported to have several undisclosed illnesses within months of getting the implants put in. There is no specific information regarding any diagnoses or symptoms. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. Link.

Body Parts Removed: 

I have been on a decline in my health since i had implants placed over the muscle in 2000. I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. I also have become intolerant to smells and chemicals. Link.

Unknown if it is Mentor saline or silicone: 

Mastitis, swelling, nodules and varius other illness. Test (unk) dates but will get. Multiple symptoms continue. (b)(6) of this year started a severe decline in my health. Have various test. Pathology and currently waiting to explant. Trying to get original doctor surgeon to release my medical records. Link. (Unknown if it is Mentor saline or silicone).

Sudden decline in health and increase in pain of area of implants as well as systemically. Chronic fatigue, weight gain, inability to be active. Link. (Unknown if it is Mentor saline or silicone).

Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. Link. (Unknown if it is Mentor saline or silicone).

Ongoing recurrent infections. Abnormal blood test results since 2012. Gi issues, pain. Menstrual period only twice or so a year (started in 2008 after implants). Palpitations. Link. (Unknown if it is Mentor saline or silicone).

This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). It is one of 2 ablations in less than a year. It is related to my breast implants in my opinion. Mainly because shortly after getting the implants in 2004, i started experiencing rapid heart rate which was eventually controlled with beta blockers, but then i started having pvc’s more frequently and not always controlled by medication. I started having sensitivity to foods which i never had before and the foods cause pvc’s. I was diagnosed with hashimoto’s thyroiditis 3 years ago. I am tired all the time despite excellent diet and plenty of exercise. I experience brain fog, trouble recalling words and i’m only(b)(6). I am cold all the time and my hormones are poorly balanced on their own. Link. (Unknown if it is Mentor saline or silicone).

Bilateral breast pain from breast implants. Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. Link. (Unknown if it is Mentor saline or silicone).

It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. Date of explant is scheduled for (b)(6) 2017. Multiple attempts have been made to obtain clarification on this event. However, no further information has been made available. Link. (Unknown if it is Mentor saline or silicone).

Had breast augmentation done. I have had recurrent bacterial vaginosis, uti’s, black-ish green discharge form breast nipples (tested and came back as staph infection). Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines. Link. (Unknown if it is Mentor saline or silicone).

I got mentor implants. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. Have had so many tests/labs and everything from chronic fatigue, fibromyalgia, sjogrens, non-specific autoimmune, rashes, brain fog, body aches, night sweats, headaches, muscle weakness, always cold. Can’t handle the sun anymore, can no longer jog/run. Some days can’t get out of bed. Link. (Unknown if it is Mentor saline or silicone).

I have been ill for past several years with autoimmune illness. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. Cognition problems, neurological issues. Link. (Unknown if it is Mentor saline or silicone).

Teague urinary incontinence, dry skin, sjogren’s autoimmune, hair loss, burning around the breast tissue, two air forms of thyroid cancer, chronic fatigue. Link. (Unknown if it is Mentor saline or silicone).

I have mentor breast implants that were placed in (b)(6)2007. I have had numerous health issues over the years since the implants but this winter, things got worse. Ongoing unexplained upper respiratory infections (went to sinus specialist and despite numerous tests she could not find cause), body rash, large itchy painful welts on my breasts, heart palpitations, anxiety and depression, joint pain, ringing in my ears, etc. Link. (Unknown if it is Mentor saline or silicone).

One of the first signs that something was wrong was in early (b)(6) 2009. I was hospitalized for rapid heart rate and low blood pressure. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. I was able to return to a mostly normal life, although the symptoms never went away. From that time on, i developed more and more symptoms that piled on top of each other. They ranged from fairly benign to increasingly more serious and problematic. I suffered bouts of vertigo; a rash that left painful sores, ringing in my ears, balance issues, bladder and kidney issues, a diagnosis of interstitial cystitis, memory and cognitive problems, food sensitivities and debilitating digestive issues, constant nausea, neurological issues, tunnel vision, shortness of breath, heart palpitations, debilitating weakness and fatigue. I grew increasingly weaker and more ill. I was no longer able to work and was placed on disability. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. No one had any answers for me. One weekend in early 2014, i took a severe turn for the worse. I could no longer get out of bed and had to have assistance bathing and dressing. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. We began to wonder if my illness could have something to do with my implants. My husband began to research that possible relationship. In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. Over the past 3 years i have slowly begun to improve. I can walk short distances with the use of a cane; i still have to use an electric scooter or be pushed in a wheelchair if i have to stand for long or go very far. I still have most symptoms, but many have improved at least slightly. I have been unable to return to the job that i loved. I used to be an active, social, happy, hard-working person. Now i rarely leave my house – never without assistance. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. I feel like a virtual shell of the person that i once was. I would give anything to have my life back. Damaged/faulty implants have ruined my health and many aspects of my life. Link. (Unknown if it is Mentor saline or silicone).

Manufacturer Issues: 

It was reported by a customer that a shipment of mentor memory gel breast implants was received with damaged packaging, bugs inside the shipping box and black underneath the seal. Per the customer, the plastic wrapping the implant boxes was also damaged. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. Link. (1/5/17)

It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. There was no patient contact reported. The procedure was completed with different device. It is unknown where and how the issue occurred. Link.

It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. Link.

It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. The implant was labeled as 325cc but the implant had volume of 375cc. No patient consequences were reported. Link.

During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. The implant packaging was opened and inspected on the sterile field table in the or. The surgeon noticed a piece of plastic that was attached to the outside of the shell. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. The implant was removed from the field and a new implant was used for the procedure. The device was given to the manufacturer representative by the or staff for further investigation. No harm came to the patient. Manufacturer requested implant and packaging directly from or team to investigate. Link.

BIA-ALCL:

Mentor Textured Silicone Implants. Bia alcl – swelling – around implant – need aspiration. Link.

It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. No further information is known regarding the patient’s medical history, status, hospitalizations, medical or surgical interventions that were performed. Manufacturer site is unknown. Multiple attempts have been made to obtain clarification on patient information as well as catalog, lot number and manufacture site of the devices that were used during this procedure. However, no further information has been made available. Mentor reports this event with an abundance of caution. Link. (Unknown if it is Mentor saline or silicone).

It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. On (b)(6) 2016 she underwent revision operation due to breast implant leak. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. Breast tissue was not sent for histology at that time. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. After 2nd scar revision surgery, breast tissue was sent for pathology and she was diagnosed with implant-related anaplastic large cell lymphoma on (b)(6) 2017. Site of lymphoma: right side. It was unknown whether cd30 positive or alk negative. Alcl stage and alcl treatment are unknown. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. However, no further information has been made available. Link.

It was reported via an fda medwatch form (#mw5072162) that a patient who underwent breast prosthesis implantation with a mentor textured gel device on (b)(6) 2015 was diagnosed with bia-alcl. The patient also reported swelling around the implant that needed aspiration. The patient reports that the device was explanted on (b)(6) 2017. Per the medwatch form, extended hospitalization was required. No patient information (name, phone number, email, date of birth) was provided, therefore no follow up was completed, and there is no additional information available.

This event was reported via # medwatch (mw5032276). It was reported that one female was implanted with mentor silicone breast implants in 2006. She was diagnosed with rheumatoid arthritis one year later. She had hashimoto¿s disease, chronic fatigue, brain fog, possible alcl according to the physician. She was scheduled to remove implants the following month. No contact information was provided in mw report, therefore no further information has been made available. Link.

I have breast implants since 1993. In 2016 i had a breast reduction with old implants removed and new implants to put in. I was diagnosed with alcl in 2016. Went through chemo then had a stem cell transplant in (b)(6) 2016. Link.

Other Cancers:

I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram. I had informed the technician that i had them. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. I went to the er, where they weren’t sure what was wrong and gave me antibiotics, which had no effect. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. I hadn’t been contacted for several months because the breast tissue itself looked normal. The mammogram film showed the bursting of the implant. I contacted a plastic surgeon at (b)(6), and scheduled an explant. At this point, it had been about 9 months of sustained acute illness. The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find. Most of the missing silicone was never accounted for, though. I started to feel better after that surgery. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Polycythemia vera rubra. I am being treated for this currently. Link.

It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). The patient had a mammogram done on 10/20/2015 that showed ¿some micro calcifications in the left superior breast¿ and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. They also recommended ultrasound at the discretion of the radiologist. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. Mri confirmed that bilateral implants were ruptured. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). The patient has no family or personal history of breast cancer before this diagnosis. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. Link.

Pre and Post Approval Studies: 

Two major issues, deformity and a rare autoimmune disease seen in much older adults. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Six months after that surgery the left capsulized; however, surgery was not safe at the time. Eventually by 2007 both implants were capsulized. Even though i was under a trial study, mentor never contacted me and i don’t think the surgeon reported as per the agreement i signed. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. Only effects hip and shoulder joints. I was unable to walk or open windows or cupboards. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. Constant fatigue, nausea, weight loss and ibs. No tumors found despite a positive test for tumor. Link.

Breast cancer in 2000, so i chose reconstruction with saline implants. Within several months i developed capsular contracture in r breast. Due to length of initial surgery as well as length of hospitalization, i chose to wait. In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. I actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. I had these mentor silicone implants placed in 2007. In 2012 while leaning over the side of tub, i heard a pop, experienced a sharp shooting pain that went straight thru my left breast. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. Pain persisted for months but eased in time. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. Weight began to plummet, as did blood pressure and just all over general malaise. In 2017, i chose to have implants removed. Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. Surgery lasted longer than expected due to the difficulty of removing the silicone. I was sent home and within 2 days i began hemorrhaging from left breast. Was rushed to surgery, large hematoma was removed and hospitalised for several days. Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. Rushed to surgery for third time. Left breast had infection both under muscle and within the breast cavity, so implant was removed. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. I was given iv cipro for several days. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. Released from hospital after 5 days. As of today, (b)(6) 2017, i’m taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because i’m fatigued. Urine test show protein, my legs, ankles and feet are swelling, still experiencing pain in left wound, hard round know has formed in the center, some swelling remains, as does pain. Wound is not healing properly. Plastic surgeon does not know if or when surgical correction can take place. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. Link.

Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. Swollen hands, tingling in the hands and arms when i bend my joints. Had frozen shoulder. I feel weak more as time goes by. I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants. Apparently mentor did not get the message about a ban on implants. Now all i want is my life back. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Link.

It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). The patient had a mammogram done on 10/20/2015 that showed ¿some micro calcifications in the left superior breast¿ and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. They also recommended ultrasound at the discretion of the radiologist. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. Mri confirmed that bilateral implants were ruptured. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). The patient has no family or personal history of breast cancer before this diagnosis. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. Link.