Breast implants have been under fire recently — there are numerous reports of leaks and “silent” ruptures leading to breast implant illness and even lymphoma, a cancer that affects the immune system.
The FDA called a meeting of the GPSD Committee (General and Plastic Surgery Devices) recently to discuss and recommend action on breast implants. More than 80 women who suffered after receiving textured breast implants and expanders testified. The FDA GPSD Committee is composed of doctors and one patient representative, Rachel Brummert. The committee was asked to determine the benefits versus risks of breast implants and their link to breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII).
Rachel Brummert, patient advocate and member of the FDA panel that recently reviewed breast implants, offers her perspective on the proceedings. — eds.
Even before I saw the media cameras, I knew this hearing would be different from any panel I had already served on.
As I took my seat on the panel, I watched as members of the media interviewed people in the hallway and the back of the packed room. It reminded me of when I testified at the FDA in 2015, on a medication safety panel about the adverse reactions I had to Levaquin. Only I was on the other side of it this time; I was a member of the advisory panel on a medical device panel. Being on both sides of the podium gives me a unique perspective about advisory panels, and I was certainly feeling the pressure. Clearly, a lot was riding on this.
The Hearings Increased My Concerns
After two days of testimony from more than 80 harmed women, breast implant manufacturers, access to medical studies and discussion among committee members, my concerns about guidelines and the information available to patients about breast implants and expanders are many.
Based on scientific research provided to the panel committee and concerns from patients, it appears that women are getting sick from breast implants and even developing lymphoma from textured silicone gel implants. It is specific to only textured implants or expanders, and this raises concerns for me. Women who survive breast cancer and then opt for breast reconstruction are potentially signing up for a different kind of cancer — a man-made one. Because of this risk and based on scientific research, over 40 countries have banned textured silicone gel implants. The US has not taken any such action, and is instead finding ways to put a Band-Aid on a battle wound. As consumer representative, I recommended that the FDA ban textured silicone implants because the lymphoma is specific to this particular type of implant, and I was met with swift pushback from my fellow committee members, all doctors.
Another issue that was raised was screening for silent ruptures. Currently the FDA recommends an MRI three years post implant, and then every two years following. The FDA and the breast implant manufacturers cite noncompliance from patients as the reason for alternative screening options. MRIs are expensive and often not covered by insurance. They add a financial burden to an already complex situation.
A Suggested Remedy that Could Cause Harm
To lower the cost of follow-up, one member of the panel suggested mammograms as an alternative to MRI screening. I had to make sure I’d heard that correctly, because using mammograms for breast implant screening is, in my opinion, ridiculous.
Mammograms are X-rays of the breasts. A technician will help you position each breast between the plates and the machine essentially squishes your breasts flat so it has a clear image. If you’ve ever had a mammogram, you know how necessary screenings are — but also how uncomfortable they are, even under the best possible conditions.
Now imagine having breast implants. The panel likened breast implants to a water balloon, so I’ll use their reference for context. Imagine a water balloon between two plates and squeezing it flat. It could rupture, right? The same goes for saline and silicone gel implants, which are prone to silent ruptures even without squeezing, through no fault of the women who have them implanted. So the solution proposed by a physician on the panel was to use a machine that could cause rupture — in order to screen for rupture!
If MRI screenings required a laboratory examination of samples of body tissue when seepage or ruptures are are found, MRIs would be much more likely to be covered by insurance and women would be able to afford to comply with MRI screenings, thus taking a riskier procedure like a mammogram off the table.
I’m disappointed with how tone-deaf most of the panel was after two days of testimony from breast implant device makers and the 80+ people who came to speak about their harm.
The advisory panel also discussed registries to track adverse events. The concern I raised was that there are several registries in existence with varying parameters. Because of their limited scope, data is incomplete. Case in point: Current registries only include new surgeries and reoperations and do not include breast implant illness. My suggestion to the panel was to create a centralized, universal registry where anyone can have access to the data — analysts, physicians and patients alike — and to make reporting mandatory.
Improving Informed Consent
This brings the subject of informed consent into sharper focus. The information from breast implant device manufacturers is sorely lacking. It’s either buried in thick booklets that are too long, full of jargon the lay person doesn’t understand, or is just not reaching the patients at all. The same goes for checklists: Consumers can’t make an informed decision if they don’t have full access to the information. By creating a streamlined public registry that consumers have access to, the consumer has more information. In the same vein, I also suggested that patients have a seat at informal committee meetings, from which they are currently excluded. They know what information they would like to have received before implant because they are living examples of what went wrong and what information women who are considering surgery should have prior to implant.
Having been on both sides of an FDA hearing — both as a harmed patient and as someone who has input on a medical device panel — I feel that the panel was overall tone-deaf. The point of these hearings is to analyze scientific data and combine that with listening to the testimony of patients who have been there so that accurate information is gathered and informed, careful decisions are made.
The FDA has the responsibility to protect consumers. In my opinion, consumers should have a say in recommending changes. Otherwise we are doing them a grave disservice.