As FDA warns of implant perils, new questions arise about 3D mammograms

breastimplantAngry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.

But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”

The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution.  The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients:

“[Breast implants] are not lifetime devices and that the chances of complications [due to them] increase over time. The warning also would list the devices’ association with a rare form of lymphoma and say some patients have reported fatigue, muscle aches and joint pain. The agency also proposed that patients be given a checklist to guide conversations with their surgeons about the risks and benefits of implants before women put down deposits for their surgeries.”

As the newspaper also reported:

“The FDA’s steps are the latest effort to deal with reports of complications involving devices that have been at the center of sometimes angry debate and legal actions for decades. The devices are used in about 400,000 surgeries in the United States every year, with 75% of the women involved getting implants for cosmetic reasons. Most of the rest get them as part of reconstruction after surgery for breast cancer. Over the past few years, patients who say they were harmed by the devices have become increasingly active on social media sites that have enabled tens of thousands of patients to exchange information. The emergence of a rare cancer linked to implants in recent years also has drawn more attention to potential health problems associated with implants. The FDA has said that 573 cases worldwide have linked the implants to a rare cancer since the agency began tracking the issue in 2011. The vast majority of those cases involved Allergan textured implants, which have been recalled. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system, the agency said. At the same time, thousands of women have complained of fatigue, brain fog and other problems that collectively are called ‘breast implant illness.’”

Implant makers have insisted their products are safe. Surgeons at the hearing earlier this year pleaded with regulators not to go overboard and ban implants again, arguing the devices benefit women, especially if they have undergone cancer-related mastectomies.

Just before the hearing occurred, an investigative journalism group reported that the FDA had received 20 times more complaints about breast implants than the agency publicly disclosed. The International Consortium of Journalists said the FDA has claimed it took a few thousand reports of harms when the actual number approached 350,000 since 2009.

The current furor over breast implants is especially problematic, because it echoes earlier major issues with the devices, which caused lawsuits to stack up in the courts in the 1990s. Implants can be helpful, appropriate, and responsible for women. But their increasing popularity, notably for elective augmentation, should give pause. This is truer because of what we know both about the device’s durability and what occurs with breast procedures. As the investigative journalists reported:

“The FDA’s own safety notices [already] warn that as many as one in five women who receive breast implants will get them removed within a decade due to complications such as rupture, deflation, and the painful contraction of scar tissue around the implant, known as capsular contracture.”

The New York Times also earlier reported:

“Surgeons who perform reconstructive breast procedures learned only recently — to their surprise — how burdensome the procedures can be for patients: 1 in 3 women develop  postoperative complications over the next two years, with 1 in 5 requiring more surgery, and in 1 in 20 cases, the reconstruction failing, [according to] published findings of medical researchers.”

Breast cancer, after cancer of the skin, is the most common cancer in women. About 268,000 women will receive diagnoses of invasive breast cancer in 2019, according to estimates by the American Cancer Society. More than 41,000 will die of the disease.

Doctors and patient advocates long have pushed early detection and testing as ways to reduce breast cancer’s toll, including the need for reconstructive procedures and implants.

Massive marketing for 3d mammography

But the independent, nonpartisan Kaiser Health News service deserves credit for taking on what it calls a “million-dollar marketing juggernaut” designed to flog 3D mammograms, which reporter Liz Szabo described as “closer to a mini-CT scan.” As she quoted experts:

“Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.”

The procedure hasn’t shown itself to be an improvement over existing scans. As Szabo reported:

“The American Cancer SocietySusan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms. When the [FDA] approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective at finding breast cancer ― not at improving survival.”

The test nicks each patient for $50 or so more than current mammograms. That may not sound like much. But it already has added up to hundreds of millions of dollars in new charges, many of them covered by the federal government and paid for by taxpayers. Further, Szabo found:

“Enthusiasm for 3D has sparked a medical technology arms race, with hospitals and radiology practices competing to offer the newest equipment. Patients have caught the fever, too. When rural hospitals can’t afford 3D machines, foundations often pitch in to raise money. More than 63% of mammography facilities offer 3D screenings, first approved for sale in 2011.”

Fueling the hot prospects for 3D, of course, is a behind-the-scenes machinery that would make P.T. Barnum blush. The device makers have sprinkled more than millions of dollars on influential doctors for, yes, research but also “speaking fees, consulting, travel, meals or drinks,” all to promote the new scans. The makers also have targeted consumers directly with millions of dollars in celebrity ads, and the firms have shelled out big dollars to lobby lawmakers. Key medical associations also have been targeted for corporate largess intended to sway them to endorse 3D scans.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by defective and dangerous products, especially of the medical kind, and by over-testing, over-diagnoses, and over-treatment. Women for too long have borne the brunt of many kinds of unacceptable medical mistreatment, and if they must cope with regrettable societal pressures to make surgical or cosmetic adjustments to their appearance, here’s hoping they do so with great care.

But lawmakers and regulators also need to get off their duffs and do more to safeguard women’s health. The FDA’s latest breast implant action is tardy, at best, and it speaks poorly for how the agency is executing its watchdog role that victimized women had to lash officials in public before regulators acted on a mountain of consumer concerns.

As for 3d mammography, it is worth listening to Otis Brawley, a doctor, Johns Hopkins professor, and former medical head of the American Cancer Society, who has argued that just because a technology is new, it doesn’t mean it isn’t beneficial — and it may cause still-to-be-detected harms. He told Szabo: “It’s unethical to push a product before you know it helps people.”

The medical establishment already has sown unacceptable confusion about testing and screening for reproductive cancers — breast cancer in women and prostate cancer in men. As Brawley also warned Szabo:

“Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them ― or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need. A 2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, ‘we could potentially hurt women,’ Krist said.”

We’ve got a lot of work to do, so we do much better by women and their health.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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