Voluntary recall of textured device raises more alarms about breast implants

bimplants-300x150An Irish medical manufacturer voluntarily withdrew its textured breast implant and related tissue expanding devices from markets after the federal Food and Drug Administration tracked a spike in a rare cancer and deaths tied to the products and asked that they be recalled.

U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant:

“Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.”

Officials don’t know yet why the textured implant is associated with anaplastic large-cell lymphoma, a rare cancer of the immune system, the New York Times reported, adding:

“It is not breast cancer but develops in tissue around the implant. In most cases, removing the implant and the scar tissue around it cures the cancer, but if it is not detected early it can spread and kill the patient. The condition has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer.”

The newspaper added this problem fact: “The FDA first recognized the link to breast implants in 2011.”

Angry women patients earlier this year besieged the agency and its officials in a public hearing about implants and breast enlargement surgeries, which the New York Times reported, are “the most popular type of plastic surgery in the United States, with more than 300,000 operations performed in 2017, a 3%  increase over 2016, according to the most recent data from the American Society of Plastic Surgeons. About 100,000 other women received implants in 2017 during reconstructive surgery after mastectomy for breast cancer in the United States.”

Plastic surgeons, regulators, and medical device makers have battled for decades over implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the devices, notably silicone though not necessarily saline fillings, may harm women’s health. The recent texturing of the breast implant’s surface was not for appearance’s sake but for surgeon convenience, supposedly easing the placement and sustained positioning.

It has raised global alarms, including reporting by the International Consortium of Investigative Journalists (which published the photo above, showing the devices.) Women in the public FDA hearing this spring assailed the agency for failing to ensure the device’s safety and questioning why doctors and hospitals are not required to better inform patients about the risks of implants and breast augmentation and reconstruction procedures.

They made excellent points. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the tragic catalog of ways in which the medical establishment mistreats women, notably with defective and dangerous products of the medical kind. Doctors, especially surgeons — with tradition-based privilege that should alarm all patients — too often experiment on women with techniques and gadgets, finding years later these may have inflicted a terrible toll.

Medicine’s mistreatment of women

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration only recently yanked from the market a surgical mesh widely used to repair pelvic conditions in women. The agency was slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused disfigurement, pain, bleeding, and scarring.

The agency has been assailed for allowing on the market the Essure birth control implant — albeit with heavy restrictions — after women reported it caused pain, bleeding, and allergic reactions. The maker withdrew the device.

The FDA also has come under fire for its limp oversight of minimally invasive gynecological surgeries that are supposed to be faster, easier, and more convenient for patients, while causing them less scarring and complications. Instead, research studies have shown the procedures may spread cancers, especially if a tissue grinding device — a so-called morcellator — is used. The FDA has issued sharp warnings about the morcellator but has declined to ban it, and surgeons keep using it. The agency also has cautioned surgeons about using robot devices for mastectomies and other procedures still not FDA cleared.

Women also are not alone in struggling with injuries tied to medical devices. Pro-business forces in Congress, the Trump Administration, and the FDA itself have in recent years pushed regulators to speed reviews and ease federal oversight of medical devices, arguing innovative and beneficial approaches should get to markets as fast as possible to assist patients. But this has created a Wild, Wild West, critics say, in which products injure millions of people around the world in big and small ways and makers get bureaucratic passes, including FDA assistance in hiding from public view more than 1 million reports of patient harms.

This all is unacceptable and needs remedy by regulators, lawmakers — and yes, you and me. For women, especially, we may be past the time in rethinking American society’s obsession with youth, appearance, and beauty. Reconstruction is one thing, particularly after major cancer operations. But how much risk, pain, suffering, damage, and death should we allow or encourage, including spending billions on cosmetic measures?

The New York Times reported that the FDA, as part of its ongoing review of breast implants, is considering changes to the product labeling, “like adding a black-box warning to draw attention to the risks, and requiring doctors and patients considering the surgery to go over a checklist to help women understand the benefits and risks of the devices.” That’s a start, but we have far to go to ensure patients’ safety with implants and other medical devices.

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