: FDA Recommends New Labeling Guidelines For Breast Implants
Despite emotional testimony from women who say their breast implants made them sick with cancer or autoimmune symptoms, the Food and Drug Administration (FDA) has no plans to ban the textured implants that are being blamed.
At a March 25 hearing, an FDA panel supported better product labeling and informed consent about the potential dangers of the devices, including a new, breast implant-related cancer and an autoimmune syndrome; education of women who already have implants about the signs of the cancer so that they and their doctors can detect it early; and an enhanced national registry of women with implants, which would allow tracking of specific device types to see if they are tied to the illnesses. A representative of the Plastic Surgery Foundation said it is working to establish such a registry.
The panel also agreed that more research needs to be regarding how breast implants can play a role in the development of cancer and autoimmune conditions. Josef Zundorf, M.D., of the German Federal Institute for Drugs and Medical Devices, testified that an international consortium will prepare research proposals on these topics to be considered in the second half of this year.
Two Kinds of Illness
At issue are two kinds of illness. Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare type of non-Hodgkin lymphoma that arises specifically in women with implants; it was first identified about 20 years ago. Breast implant illness (BII) is a constellation of autoimmune issues that can include chronic fatigue, fevers, brain fog, and joint pain. Either can affect women who get implants after mastectomy due to breast cancer or a predisposition to the disease.
“Four years ago, I was diagnosed with BIA-ALCL, stage IV, from six-year-old implants, and life as I knew it ceased to exist,” said Terri McGregor, of Ontario, Canada, who was treated with chemotherapy, the targeted drug brentuximab vedotin ( Adcetris) and stem cell transplant–which gave her another type of cancer. “The isolation and betrayal of our cancer is compounded by the dismissive PR campaign of industry. They stayed silent, and when our existence could no longer be denied, we were merely portrayed as anomalies.”
Textured implants, as opposed to those that are uniformly smooth, have been associated with BIA-ALCL, although in some cases the type of device that was implanted is unknown. The disease can arise from implants filled with either saline or silicone, according to the American Society for Aesthetic Plastic Surgery.
There have been 800 confirmed and unconfirmed reports of the disease worldwide within a pool of 10 to 35 million breast implantations, Zundorf said. Of those, 457 cases, including 9 deaths, occurred in the United States, said Karen Nast, RN, of the FDA’s Center for Diseases and Radiological Health (CDRH).
The chances that a woman with a breast implant will develop BIA-ALCL are between 1 in 3,000 and 1 in 30,000, and the disease typically occurs about a decade after implant, said experts who testified.
There are several theories about what causes the cancer, said Raina Duria of implant manufacturer Mentor. One is that the increased surface area on textured implants can provide a foothold for bacteria introduced during surgery, which can result in long-term inflammation and eventually disease. Another theory blames particulates in the breast capsule (the tissue that forms around an implant in about half of women who use the products) or free silicone particles on implant surfaces. Experts testified that some women may be genetically susceptible to BIA-ALCL, but added that more research is needed.
Jennifer Cook of Georgia, who received a diagnosis of BIA-ALCL in 2017, said that surgeons should be required to provide informed consent about the risk of the disease. Cook said she received her implants as part of a clinical trial and signed a consent form stating there was no established scientific evidence linking the devices with cancer. Over many years, she said, no one informed her that a risk had been established, and she found out only by watching a play on the topic at the middle school where she taught.
“I was shocked and thought I would need to reprimand the students for making false statements, and then I learned the horrifying truth,” Cook said. “Shortly thereafter, I recognized that I had symptoms. I was blindsided, I was deceived and I don’t want anyone else to go throught that.”
BII, meanwhile, seems to occur more often in women with personal or family histories of autoimmune conditions, experts said, suggesting that more research is needed and that women who have these histories should be warned before getting implants. One expert went as far as to say that these women should opt against implants.
Patients called on authorities to give the condition an official name, formally tie it to breast implants and stop dismissing women who complain of its symptoms. While the syndrome is not recognized by many doctors or health insurers, there are more than 170 groups and communities devoted to it on Facebook alone, the largest including more than 70,000 members, according to Jamee Cook, of Breast Implant Victim Advocacy.
Some members of the public, including some surgeons and a breast cancer survivor who has implants, testified in favor of the devices, saying that they are largely safe and provide a meaningful psychological boost for women with deformities who seek augmentation or who have undergone mastectomy.
Patients, however, told horror stories of declining health, hospitalizations and lost jobs. Some suggested that the implants that made them sick also left their children—conceived or breastfed while the devices were in place—with lasting health problems.
“Breast implant illness has cost me everything,” said Terry Diaz, who described being “bedridden and waiting to die” and said she couldn’t walk up stairs when she had the syndrome. “l had to close my business and I’m being accepted into chapter 13 and home modification, but still may lose my home. I can’t afford health insurance or medical care. I’m no longer bedridden and about 85 percent better, and the only medical procedure I had was explant. I lost 10 years of my life due to ‘safe’ implants.”
The patients who testified said that surgeons should be more up-front about potential side effects and the high likelihood that reoperation—an expense that may not be covered by health insurance—will be needed over time due to leakage, rupture, capsular contracture (a sometimes painful complication that can occur in the tissue that forms around an implant) or other health problems. They also urged the FDA to authorize ultrasound as a cheaper, more reliable way of checking for BIA-ALCL than the only modality currently approved—MRI, which can cost women $2,600 out of pocket and is therefore inaccessible to many.
Patient requests also included research about the safety of implants during breastfeeding; an FDA requirement that implant manufacturers reveal the ingredients in their devices; and the removal of textured implants from the market.
About 20 percent of the breast implants used in the United States are textured, while the rest are smooth, said Stephanie Manson Brown, a representative of implant manufacturer Allergan. The opposite is true outside the country, she said.
Brown stated that textured implants have a role to play, as they are anatomically shaped, stay in place better than smooth devices (which are round) and may be associated with a lower rate of capsular contracture. But one panelist questioned whether even smooth implants provide a safe option, since many surgeons—in a practice not approved by the FDA—wrap mesh around the devices to better keep them in place.
Representatives of breast implant manufacturers called ALCL a slow-growing T-cell cancer and noted that it’s usually curable through the removal of implants and any affected tissue around them. Brown added that, when health insurance doesn’t cover ALCL-related expenses, “We’ve committed internal resources to assist surgeons for patients in these circumstances. We give financial assistance for evaluation and any treatment associated with BI-ALCL.”
A patient, however, accused the representatives of trivializing what she called a “manmade cancer.”
Manufacturers discussed their efforts to track patients and their outcomes in FDA-mandated company registries. Registries have been required since 2006, when silicone gel implants were put back on the market after being removed in 1992 due to concerns they were tied to illnesses.
Two companies, Mentor and Sientra, recently received letters from the FDA citing them for insufficient follow-up with users of their products. In addition, panelists complained that the studies the companies submitted to the FDA have different formats and timelines and can’t be compared.
Manufacturers’ representatives said it’s challenging to collect this information because many women choose to leave the studies. However, some patients countered that they had remained engaged in follow-up studies—until manufacturers canceled them.
“These post-approval studies were required by the FDA, but they’ve been flawed and incomplete and not reliable,” Jamee Cook said. “There’s been a failure to complete studies. Some women got lymphoma that would have been documented (if the studies had continued). Some women were told a study stopped or that the doctor had dropped out. Or, women were dropped after reporting symptoms. We’re missing data because of this.”
A national registry should track issues including patient and family health history and prior use of breast implants, said Binita Ashar, MD, of the CDRH. Zundorf said it would help to develop a national system for classifying the surface texture of implants, so it will be possible to compare the findings of registries tracking BIA-ALCL across the world.
This article originally appeared on CURE as "Breast Implants Stay on the Market, but FDA Wants to Know More About Lymphoma and Autoimmune Syndrome."