Disclaimer: Views in this post are my own and does not represent the views of the FDA.
On March 25 and 26, the Food and Drug Administration held a hearing regarding the benefits vs. risks of breast implants indicated for breast augmentation and reconstruction. The Advisory Panel was tasked with making recommendations regarding:
- Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
- Systemic symptoms reported in patients receiving breast implants
- The use of registries for breast implant surveillance
- MRI screening for silent rupture of silicone gel filled breast implants
- The use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
- The use of real-world data and patient perspectives in regulatory decision-making
- Best practices for informed consent discussions between patients and clinicians.
As a Special Government Employee (SGE) for the FDA, I served as Consumer Representative for this hearing. This blog post is my perspective as the Consumer Representative on the panel.
Advisory panels typically have 20 members, made up of FDA staff, physicians, an industry representative, a consumer representative, and a patient representative. My role as Consumer Representative at the FDA is to analyze scientific data, represent the best interests of consumers, and make recommendations to the FDA about changes that should be implemented.
The list of speakers has 81 names on it. Over 2 days, it was 4 hours of testimony from breast implant victims, survivors, surgeons, and public health organizations. That so many people traveled to Silver Spring, Maryland for this hearing on their own dime to speak about the harm of breast implants is very telling.
At the two-day hearing, there were presentations from patients, the FDA, and device makers Allergan, Mentor, Sientra, and Ideal. As Consumer Representative, I can ask questions to the FDA and to the device makers. The panel Chairman did not call on me or the Patient Representative when we wanted to ask questions. During the break, we asked to speak with him privately and told him it is not acceptable to ignore the representatives if we had questions or comments. He apologized and did call on us when we raised our hands after that.
One of the issues I raised after analyzing the data on textured implants causing lymphoma was that textured implants should be removed from the market. Over 30 other countries have removed them from the market due to the risks, yet the United States has not taken any such action. Some panel members took issue with my comment about removing it from the market, stating that “we should not be making knee jerk decisions like that”. I disagree. The science is there. The link between textured implants and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is obvious. There’s nothing “knee jerk” about it.
Let me clear about something: BIA-ALCL is NOT breast cancer. It is a man-made cancer specific to textured gel breast implants. So women who survive breast cancer and opts for breast reconstruction is potentially signing up for yet another cancer. Let that sink in.
BIA-ALCL is often called “rare”. It’s not rare. It’s that it isn’t clearly understood, the surveys used to track data are long, patients are suddenly dropped from studies, and patients are often not informed properly.
The panel also discussed adverse event registries. While I think they’re a good idea, there are too many. It makes it confusing, there are different parameters for each one, and they are exclusionary. Current registries contain information for new surgeries and re-operations. That excludes a large population of women who are in limbo because they can’t afford explants, and if information is excluded, you’re not getting accurate data. They are based on voluntary reporting, and not on medical records. In addition, Breast Implant Illness (BII) is not included in registries so the data is incomplete. My recommendation to the panel was to have a centralized registry that anyone can have access to. Current registries do not make data available to patients. It does a disservice to patients when information that should be transparent is withheld; otherwise, there is no informed consent. I also recommended that registries include Breast Implant Illness. I also feel that registries should be linked with electronic health records. The current system is based on diagnosis, not on the complete picture of symptoms.
The device makers claim that they provide information and checklists. However, patients are not getting that information – a point made by almost all of the speakers. When the issue was raised during panel deliberations, Mentor later provided a booklet with two pages bookmarked. Not everyone on the panel got the booklets so some of us had to share. This made me uneasy so I snapped photos of the booklet and the bookmarked pages. My instincts were right. I got to look at it but the Industry Representative held on to it. It’s a 70+ page booklet with a checklist that is insufficient. 70+ pages is a lot to read, information is buried, and most concerning is the fact that patients never see it. The booklets are given to physicians, not patients.
After seeing this, I made the recommendation to the FDA that the FDA, device makers, and patients have an equal seat at the table to devise a checklist that is succinct, clear, transparent, and to make it mandatory that patients and the physician sign off on each checklist point. These materials also need to be made available at a consultation prior to surgery, not on the way to the operating room. I asked a Mentor representative for her business card after she said she was willing to have such a meeting. If they don’t keep to their word, they need to be held accountable, and the FDA needs to be held accountable if they don’t implement this recommendation. If patient safety is truly the priority they say it is, true transparency and equal seating at the table needs to happen.
The FDA has hidden hundreds of thousands of incident reports regarding breast implants. An investigation by International Consortium of Investigative Journalists revealed that the FDA has allowed device manufacturers to bury adverse event reports using a program called “alternative summary reporting”.
Two days later, FDA Commissioner Scott Gottlieb announced that the FDA will release old data, stating that full disclosure is a priority.
Shortly before the hearing, the FDA sent warning letters to Mentor and Sientra- breast implant manufacturers stating non compliance with post market surveillance. My question is this: After the FDA sends warning letters, have they ever recalled a device? To date, the answer is a resounding no. That needs to change.
Also of note, ingredient lists for breast implants are not made public. Think about that. The food you eat, the beverages you drink, the supplements you take… they all have ingredient lists. A consumer can decide whether they want to consume those products because the ingredients are available. This is not the case with medical devices.
Breast implants are causing autoimmune and other breast implant illness symptoms. If a consumer knew what was in the implant, you add another layer of informed consent. These implants contain heavy metals, neurotoxins, carcinogens, and other harmful ingredients. Wouldn’t you want to know that? In addition, knowing what is in the implants can help during the screening process (which is also lacking).
Speaking of screening…
There is none prior to implant. Post-implant surveillance is lacking.
The panel deliberated on the use of MRI screening 3 years after implant and every 2 years after that. MRIs are expensive and not covered by insurance.
The patients who suffer with Breast Implant Illness all stated that their symptoms disappeared after explant. Explant surgeries are not covered by insurance. By mandating pathology after implants, insurance would cover it. The FDA wants to eliminate MRIs as post-implant surveillance because of non compliance from patients. If MRIs were covered by insurance and were not so expensive, there would be more compliance.
Alternatives were discussed during the panel deliberations. One was mammograms. I had to make sure I heard that correctly because I couldn’t believe this was even being suggested.
If you’re a woman who has had a mammogram, you know how it feels to have them. Now imagine having breast implants which are prone to rupture. Squishing breasts in that torturous contraption only puts women at more risk of rupture. Mammograms to test for ruptures are the very thing that could rupture them. And these were suggested by physicians. I’m no doctor but it’s one of the most ridiculous suggestions I’ve ever heard.
Ultrasounds could be a feasible option, but again, if MRIs were covered, we wouldn’t really need to have that conversation.
Deliberations also brought up the use of surgical mesh for implant surgery. In February 2019, the FDA held a hearing on the use of mesh, at which dozens of patients came forward with their stories of harm. Mesh for breast implant surgery is mostly for aesthetic purposes, and patients are not told that surgical mesh will be used during their surgery. Considering how harmful surgical mesh is, you’re adding insult to injury since both mesh and breast implants are causing enormous harm.
Mesh and breast implants are classified as a Class III medical devices. Class III are considered high risk devices. They must be life-saving or life-sustaining and include devices such as artificial heart pacemakers. Any device in this category requires only one clinical trial as part of the pre-market approval process. The testing must provide evidence that the device is reasonably safe and effective. Mesh and breast implants should not be Class III devices, and need to be reclassified as Class II. And as a side note, if you are harmed by a Class III device, you cannot hold the manufacturer accountable.
The FDA has the authority and responsibility to protect patients. I call on them to take patient testimony to heart and implement the patient safety recommendations that I, and others on the panel, brought up.
The women who have implants deserve better.
To watch the hearing:
Day 1: March 25, 2019
Day 2: March 26, 2019
For more information about how screwed up the system is for medical implants, watch The Bleeding Edge on Netflix.
9 thoughts on “FDA Breast Implant hearing- A Consumer Representative perspective”
Thank you Rachel. Great job summarizing the issues and speaking up at the meeting. I appreciate your input.
Thank you so much for this. I was in attendance and a speaker. I am appalled at how easily our concerns were dismissed, generally by the panel. The panel made it sound as if ALCL is acceptable as a risk due to how easily it was treated, if caught early. Not one of our women on attendance, clearly demonstrating the worldwide incidence is higher than current data, were diagnosed early. There symptoms were ignored till the point of taking fluid samples was the only final attempt to perform. Then the tests were ruled negative due to faulty draws and resulting. This is a malignant, man made cancer due to implants exclusively. 5he total disregard, and insult to the lives of these women, mothers, wives, daughters and sisters was repulsive. To ignore conclusive data outside of industry funded research by Dr Mark Clemens, on Allergan textured implants, is 5he ultimate in negligence. Criminal. How et he “fuck” Michael money has the manufacturer paid the panel membets?? The FDA must take a long hard look at there mission and how well they are following I Tutu.. Presently they have lost all credibility for protecting women or any patient. To squeeze mesh into a tiny slot and then bring it up to be approved alongside implants is ridiculous. Mesh is currently under scrutiny with male and female patients for hernia repair, bladder and pelvic slings. Why would it be any less problematic stuck in a breast. This is just another way to overcharge a patient for unproven material use in surgery. There is no reason, PROVEN, this is necessary to produce a better patient result. This just adds to complications, it becomes the patient’s responsibility to associate as causation.. we need insurance coverage for all medical problems a patient is experiencing with implants. Most women would NOT choose to undergo another surgery to the breast for the cosmetic result. They are having problems. If your voice can not be heard or your opinion values in contributing to these discussions and panel recommendations then why are you or the patient rep there? Is this the token app err stance of the FDA really giving a shit? As you can tell, I am passionate about this. Too many women are suffering due to so called safe devices. The information on complaints due to medical devices has been hidden to long.. Why hide this? Why are women to continue to be dispensable Guinea pigs for money $$ manufacturing companies? When will the FDA belly up to it’s responsibility to All Of us… ? thank you, Holly Davis
We appreciate what you are doing and this is an excellent summary.
The investigations from the 1990-early 2000 against Mentor should be followed up on, in my opinion. In addition the FDA officials that made statements proving the FDA was not taking action back then and still has not, should be noted.
Saline was never subjected to official studies, since many doctors believe saline is sterile water.
Saline is no longer sterile after it reaches 77 degrees temperatures after 14 days. In addition, the manufacturer faulty valve and patches allow the implant to leak a little and allows reverse flow. This means auto inflation of body fluids which allow bacteria and fungus to grow as the implant now acts as an incubator.
Scientist warned the FDA in 2000 to NOT approve Saline implants, but the FDA ignored the information from experts.
All implants removed should have fluid & capsules tested and the implant shell of both saline and silicone examined for leaks and leaching.
I again want to thank you for all you are doing to assist in making changes.
Anne Ziegenhorn, RDH
The Implant Truth Survivors Committee Non-Profit
Sincere thanks for this. It is a great summary that is brief enough for BII sufferers to share with our loved ones.
Rachel, I was diagnosed with BIA ALCL and spoke at hearing. I am so impressed with your understanding of the issues and ability to clearly set forth what needs to happen to protect the health of breast implant recipients (past and future). I submitted my ideas for what should be in an informed consent regarding BIA ALCL to Mr. Garcia. I hope Mentor is true to their word and welcomes patient input regarding informed consent and that the FDA mandates a checklist.
Thank you for this excellent summary, Rachel. Before my mastectomy/reconstruction with implants, I asked my Surgeon “Isn’t there some kind of Patient Information Manual I should be getting?” Her reply was: “Oh, you can look it up online”. By The time I got around to looking for it, I had to really dig through the mentor website and I found a copy of what you have shown here in your photos. I was a palled at the number of pages listing adverse reactions and possible illnesses that could be caused by my implants! When I went back and showed it to my surgeon, she said “oh that’s just legalese. They have to put that in there in case of lawsuits.”
In the past 3 years I’ve learned that that is a typical response from surgeons.
Something is very wrong with this system! Manufacturers need to be held accountable, but also Plastic Surgeons need to be informed!
Thank you, Rachel Brummert, for performing as a true Consumer Representative. The criteria the FDA uses to select the Consumer Representative rarely conforms to what a consumer would consider a representative. You listen to the consumers and also communicate back to consumers about the issues and decisions by the panel. This is essential. Thank you for setting the standard that should have been practiced by the FDA/CDRH. It could have PREVENTED substantial harm to thousands of women globally and their families.
Rachel-thank you -this is a wonderful summary. I had breast cancer is 2015 and reconstruction same year. I was diagnosed with BIA ALCL 2 years later in 2017. I attended the meeting in Silver Springs but did not speak.
I am hoping that this starts to bring awareness we deserve and some changes are made to the classification of breast implants. Life saving Class III device-no -but definitely life altering.
Thank You Rachel – I am so glad I found this site. I have been seeing PS after PS and I can’t find one to take me serious. Double Mastectomy 20 years ago, implants changed out twice – rupture once with saline, saline put back in, capsulized, removed and silicone put 12 years ago under the muscle. I have been in severe pain in the chest wall, back and under my arms, with swelling in the left side and now starting in the right. I have burning in my back along with sharp stabbing pains behind the implant. I knew nothing about any of this until the Plastic brought it up to me…it has been going on for over 2 months. I can’t even get back in to see him for another month for another consult before he will agree to start the insurance filing to take them out!!! MRI shows no rupture…but they didn’t look for anything else so I had a CT scan done. It came back that all is good. I love your comment about having a mammogram. Try to have a mammogram done with implants under the muscle….one Plastic Surgeon asked me when was the last time I had one…I didn’t go back. I am at my wits end with the pain. I just want someone to listen. Where are we to go and who are we to get to listen to us? Oh, and by the way – I have no idea who the manufacturer of my implants are or what type other than they more than likely textured silicone. The PS that put them in purged all my records. In the state of GA – they are allowed to do that after 10 years. Thanks for letting me vent…..and thanks for all you did.