FDA ripped over breast implant safety as agency seeks mammogram change

breastimplantUncle Sam has paid what critics have called long overdue attention to women’s breasts and how surgeons and diagnosticians treat them.

In an angry and emotional public hearing, women ripped the federal Food and Drug Administration for lax oversight of implants that surgeons use to augment and reconstruct breasts, even as the agency proposed its first changes in 15 years to guidelines about mammograms for patients with dense breast tissue.

The FDA has been under fire for decades over breast implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the implants, notably silicone and not necessarily saline fillings, may be injurious to women’s health. New concerns have developed over surface texturing on the devices, which are supposed to help in the surgery but may affect tissues around and near the breast, leading to spikes in reported cases of rare cancers.

Women told FDA medical advisors at the hearing in Silver Spring, Md., that they should have gotten much more information about implant risks. Some wore pink- and green-striped ribbons to show their solidarity with women who say they have implant-related lymphomas, while others wore black- and white-striped ribbons to stand with women with “breast implant illness,” a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue.

Implant makers have insisted their products are safe. Surgeons at the hearing 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 FDA has come under fire after the independent, nonpartisan Kaiser Health News Service reported that agency staff routinely exempted medical device makers from public complaint disclosures, allowing them, instead, to hide as many as 1 million reports of patient harms. Makers were allowed, too, to submit summaries listing multiple reports of patient harms and promising to provide details of the cases later. Outgoing FDA Commissioner Scott Gottlieb has pledged to open the agency files, but the volume and age of the hidden reports may make this promise hard to keep.

The medical advisory group took no action after its hearing, but the FDA has pledged to be more vigilant about breast implant safety.

The agency also proposed the first changes to its regulations on mammography, saying that centers that perform the tests should tell women if they have dense tissue in their breasts and provide them information on what that means.

Three dozen states, the New York Times reported, have such requirements, though they vary widely in their extent and specifics.

Women, half of them 40 and older with dense breasts, need to know about tissue density because it can affect mammography’s diagnostic effectiveness with tumors. Women with dense breast tissue may wish to undergo other screenings, including different types of imaging, and consult more closely with their doctors. This, in turn, has raised concerns by experts about over-testing and over-diagnosis, as, even among women with dense tissues, breast cancer risks can vary and depend on individualized, specific factors.

Connecticut pioneered the disclosure by testing centers to women about their breast density. State officials were pushed to do this by Joseph and Nancy Cappello, who launched a nationwide “Are You Dense?” campaign after her breast cancer was missed for years. She since has died of complications related to her cancer care.

In my practice, I see the harms that patients suffer while seeking medical services, notably the many ways in which the medical establishment long has mistreated women, including by “innovating” with their care with procedures and medical devices that too often have proven to be dangerous and defective products.

If you’re a certain age, it’s hard to watch yet another blow-up over breast implants, which caused lawsuits to stack up in the courts in the 1990s. The devices can be helpful, appropriate, and responsible for women. But implants 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 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 earlier has 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.

A key way to address reconstructive issues may turn on averting them with improved detection—including with improved mammography and other imaging—and treatment of breast cancer. As the Washington Post reported:

After skin cancer, breast cancer 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.

We’ve got a lot of work to do. Women at the very least should know if they are making giant choices between their appearance and their health or even their lives.

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