Shared with permission from Dr. Marguerite Barnett.

Dr. Barnett is one of the top expert explant surgeons and has been studying breast implant illness for over 30 years. This is her statement to the FDA for the public hearing that was on March 25th-26th.

Thank you for allowing me to submit this statement to the esteemed FDA panel. I am a board certified plastic surgeon, graduate of The Joint Harvard-MIT Health Sciences and Technology Program, who has over 30 years experience with breast implant issues. I have personally performed over 3000 explants, the majority in women who have suffered complications either in the form of local issues such as painful capsular contractures, ruptures/silicone granuloma formation or ill-defined systemic complaints such as chronic fatigue achiness, brain fog and irritable bowel. Every type of implant and manufacturer has been represented among my patients whether gel or saline, smooth or textured. While fortunately the old-style liquid ruptured gels with distant migration requiring radical excisions are becoming more rare as time passes, I have witnessed several cases of the cohesive gel ruptures which seem extremely uncohesive. We should not be surprised by this as evidence presented in the 1990s indicated that cohesive gel could be broken down in vivo and might not afford the protection assumed(1). Removal can be an arduous undertaking when the implant is in the submuscular position, the current favorite among surgeons, especially if a capsulectomy is required. It frequently is since capsules being inelastic scars, can cause restriction of chest wall motion thus leading to a common complaint among patients of inability to take a deep breath and may be interpreted as a “panic attack.” This restriction along with chronic inflammation found about foreign bodies have led to a disproportionate number of my patients undergoing complete cardiac work-ups with negative outcomes or shoulder surgeries for what in retrospect was impingement by the implant on shoulder muscles. I am not the only surgeon who has noted these issues. LuJean FengMD of Cleveland has been conducting pulmonary function testing of her patients pre and post-operatively and notes significant relief of restrictive lung parameters(2), rheumatologists at LSU have reported musculoskeletal issues in implanted patients (3) and Baylor physicians have reported on chest pain syndrome in these patients (4). These are only a few of the doctors who have given reports on these issues!

While many of my colleagues will testify that the science has shown implants to be safe, I think you are well aware of the lack of scientific testing performed on these devices. Your own scientific panel in the early 2000s, after the debacle of the moratorium on gel implants and the global settlements in which nearly a quarter of a million women signed up (some alledging serious injury), recommended that gels not be returned to the markets as the studies demanded were sorely lacking. Nevertheless, for the first time in your 100 year history, you overlooked your own scientific panel’s recommendation and allowed them to return to the market unrestricted. Not even a device registry was required and as a result, we have been caught unawares as the association between textured breast implants and Anaplastic Large Cell Lymphoma was recognized. In the course of five years we have gone from what was assured as a “one-in-a-million” chance of developing a disease that has caused a dozen deaths in the USA to as high as a 1:3000 chance and we have no way of finding out who has the devices at highest risk to warn them or conduct surveillance! Incidentally, this cancer was predicted by research in the early 1990s (5). Many of my patients have no idea of what type of implant they have! My colleagues’ response to this has ranged from “this is not a real disease (actual question on a survey sent last year from the ASPS!)” to “I cannot achieve these kind of (excellent) results without the use of (these type of implants)” to denigration of the New Zealand data on the basis that “those implant were made in a foreign country” as though the process were different in other countries!

I have no doubt that whatever process is behind this novel disease, will be shown to be behind the disabling process that my patients refer to as the “achey-tireds.” I was a trauma surgeon for a decade in the US Army and had several patients, Asian dependents of servicemen, who had undergone silicone injections to their breasts. These women suffered a variety of systemic symptoms which I was advised by my senior attendings was a result of “impure” substances which had adulterated the silicone. I am struck by how much their symptoms resemble those of my patients who have devices made of medical grade silicone. While fatigue and achiness are not as measurable as tumors, they have a very negative impact on quality of life. As noted by prior studies cited, up to 2/3rds of these patients improve once explanted. My colleagues criticize my findings and those of other doctors as being a placebo effect. These effects are real which is why most studies need to include a double-blinded placebo arm which is difficult to achieve in the case of breast explantation. Most placebo effects however are closer to 1/3rd response and the effect tends to be greatest after the intervention and lessens as time progresses. These women behave differently as the response increases the further out from explantation. I urge you to listen closely to the testimony of these patients when they come before you. Note that to a woman, they will testify that they were never warned of the possibility of these life-altering problems and/or were dismissed if they brought up their issues. Their number include physicians and lawyers, professionals who cannot be dismissed as being ignorant or uninformed. There has been a lot of science presented to the FDA during hearings in the 1990s mostly ignored by plastic surgeons which show a plausible basis for their issues especially as we now understand more about genetic variation and interactions of foreign materials with biofilms (6).

If you listen to these women and understand the large numbers involved, I think you will come to the conclusion that these devices need much more study than they have received. Do the job you were tasked to do to protect the health and safety of the public by finally requiring these studies! At the very least, please require a registry so that physicians and patients alike can understand the vast differences in these devices and how these differences affect their lifespans as well as the effects they produce in the body. Require true informed consent in the form of a mandated brochure to be given to patients BEFORE receiving breast implants which elucidates what is not known as well as what is known and the areas of controversy so that I no longer have to hear patients say they were never told of these risks. This brochure must be made with input from both the surgeons as well as consumers. I never dreamed 30 years ago that I would continue to hear the same litany of complaints I did when I was a young surgeon and I hope that I will not have see the same complaints if I make it another decade! My practice experience is open to your review and I stand ready to answer any questions you have regarding my experiences. My patients deserve to have their voices heard. Thank you for your consideration!

Marguerite Barnett MD