Breast implants: It’s women vs. industry, as mounting evidence forces FDA to take another look

Can breast implants trigger chronic illness and even cause cancer?

That question has plagued silicone gel-filled implants almost from their introduction in the 1960s, so there may be a sense of here-we-go-again when advisers to the U.S. Food and Drug Administration revisit the debate during hearings Monday and Tuesday.

But this time around, women who testify that their implants made them sick can’t be discounted as anecdotal cases, or overwrought, or motivated by a class-action lawsuit.

International health authorities now recognize that implants with roughened surfaces — both gel-filled and saline-filled — can cause a very rare lymphoma, a type of immune-system cancer. Since the FDA first issued a warning in 2011, nearly 700 cases and 17 deaths have been tallied worldwide. Three months ago, Allergan took its leading brands of textured implants off the market in Europe after French regulators announced they had suspended their approval.

There is also mounting scientific evidence linking silicone gel implants to autoimmune disorders and vaguer debilitating symptoms such as fatigue, pain, and thinking problems — just as legions of women have contended since the 1990s, when the FDA initially held hearings.

The FDA panel is slated to hear from two scientists at the forefront of research into the lymphoma and "breast implant illness:” Jan Willem Cohen Tervaert, an immunologist from the University of Alberta in Canada, and Mark Clemens, a plastic surgeon at University of Texas MD Anderson Cancer Center.

“The scientific literature at the end of the last century was heavily sponsored by industry,” Cohen Tervaert said in an interview. “Now, serious researchers are showing a different view.”

It remains to be seen whether the two-day meeting will have any impact on FDA regulation, or on the unrelenting demand for implants. Each year, about 300,000 U.S. women enlarge their breasts, and 100,000 cancer patients reconstruct their breasts, using the prosthetics.

But as more and more women come to regret their decision, they are using social media to organize and push for major changes. Terri McGregor, 54 , of North Bay, Ontario — who cofounded a Facebook group devoted to implant lymphoma after she almost died of it in 2015 — helped lobby the FDA for more than a year to hold the meeting. The activists want textured implants removed from the market. And they want a more rigorous informed-consent process because their experience suggests surgeons often omit or downplay risks with women considering implants.

“We believe no woman is ever going to say, ‘I choose the implants with the risk of cancer,’ ” McGregor said. “We’re saying that when someone is determining the risk assessment for us, instead of giving us the information we need, that is not acceptable.”

Silicone gel-filled implants came on the market in 1962, before the FDA had authority to regulate them.

By 1992, with more and more women blaming gel implants for serious but enigmatic health problems including autoimmune diseases, then-FDA Commissioner David Kessler banned gel-filled implants except for use in approved studies. The ban alarmed women and set off a deluge of product-liability lawsuits that ultimately bankrupted Dow Corning Corp., a major implant maker, and led to a multibillion mass tort settlement.

Then, as now, the regulation of implants involved public opinion, the law, politics, and commercial interests, as well as scientific evidence. But back then, the science was lacking because implants had come to market without clinical testing. When Kessler asked manufacturers for data showing the devices were safe, they couldn’t provide it.

Today, a large body of studies has measured the rates of common implant problems, including rupture, deflation, breast hardening, and infection.

The question of breast implant illness, however, remains open because existing studies are too limited or flawed to settle the matter. The public generally thinks implants have been exonerated because the FDA, implant makers, and plastic surgeons frame the lack of conclusive evidence as reassuring.

The thing is, no one has ever followed enough women for enough years to tease out the risks of rare autoimmune diseases such as scleroderma — and besides, many women suffer a constellation of symptoms with no neat diagnosis.

Jamee Cook, 41, had to quit her job as a paramedic because of migraines, memory problems, fatigue, fevers, enlarged lymph nodes, and more. The removal of her implants in 2015 dramatically improved her health — and turned her into an activist. She is an invited speaker Monday morning.

“I keep hearing that the 1990s was money-driven,” said Cook, who lives near Dallas. “We’re speaking out now because we’re sick, not to get money.”

On its website, the FDA acknowledges the conundrum of rare and ill-defined illness: “In order to rule out these and other complications, studies would need to be larger and longer than those conducted so far.”

To address this need, the FDA directed Allergan and Mentor Worldwide to undertake large, decade-long studies beginning in 2006 when the agency lifted its 14-year-old ban and allowed gel implants back on the market.

But after reaching enrollment goals, the companies’ studies fell apart. Within several years, more than half the participants were “lost to follow-up.” The FDA responded by allowing much smaller studies to suffice. Still, deficiencies persist. Just this week, the agency sent warning letters regarding inadequate enrollment and follow-up rates to Mentor, a part of Johnson & Johnson, and Sientra, which first got conditional approval to market in the U.S. in 2012.

The FDA could withdraw approval of an implant for noncompliance with its orders, but it never has.

During Monday’s meeting, the FDA panel will get updates from the companies on the post-approval studies.

Limited though the industry studies are, Clemens, at MD Anderson, led an analysis of Mentor and Allergan data on more than 90,000 women that found gel implants are associated with slightly higher rates of Sjogren’s syndrome, rheumatoid arthritis, and scleroderma – all autoimmune disorders – as well as melanoma, the most serious type of skin cancer. The researchers stressed this does not prove implants are causing disease.

The FDA promptly issued a press release disputing the findings, published in September in the Annals of Surgery.

One criticism of Clemens’ analysis was that some of the diseases were reported directly by women, not necessarily diagnosed by doctors.

Cohen Tervaert and colleagues sidestepped that weakness by analyzing an Israeli health-care database containing doctors’ diagnoses. Compared to 98,600 women without implants, 24,600 women with gel-filled devices had higher rates of autoimmune and rheumatic diseases, notably Sjogren’s syndrome, systemic sclerosis, and an inflammatory disease called sarcoidosis, according to the paper published last year in the International Journal of Epidemiology.

Cohen Tervaert has also done lab-based studies in his native Holland, where he worked until last year, to unravel how the immune system may go awry in some women with implants. Basically, he theorizes that the implant acts as a sort of allergen, triggering a chronic inflammatory process. The resulting illness can range from fatigue, dry eyes, and body aches — all the way to the lymphoma.

Technically called breast implant-associated anaplastic large-cell lymphoma, it is usually diagnosed because of sudden swelling around the implant. It is curable if treated promptly with surgery to remove the implant and surrounding scar capsule. But McGregor, the Canadian patient activist, had no swelling. By the time she felt lumps in an armpit, her disease had spread to lymph nodes there and to her bowel.

In response to research by Cohen Tervaert’s team, Holland’s national health-care system now pays for implant removal in women diagnosed with implant disease. Doctors are also supposed to advise women with a history of allergies or autoimmune disorders not to get implants.

In the U.S., where insurers rarely cover the “explant" surgery — the cost of which starts at $5,000 — more than 6,000 women have sought advice over the past four years from the National Center for Health Research, said Diana Zuckerman, president of the health policy think tank.

“Often, they get so sick that they can’t work anymore,” said Zuckerman, who will present data from 400 explant patients at Monday’s meeting. “Sometimes even their relationships or marriages fall apart, so they really have no money. We’ve managed to help 20 percent” get surgeries.