U.S. eyes label warning for Allergen devices

FDA pressure results in breast implants that cause rare cancer of the immune system being recalled

Allergen is recalling its textured breast implants worldwide that have been linked to anaplastic large-cell lymphoma, a rare cancer of the immune system.

The company has responded to belated pressure from the Federal Drug Administration.

According to a recent story by Denise Grady in The New York Times, however, the FDA reports that women who have the implants but no symptoms don't need to remove them.

Yet the article does note "the recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergen."

The disease is not breast cancer but developed in tissues around the implant. "In most cases," Grady's story says, "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, it continues, "has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer."

Thirty-three deaths and 573 cases have been reported from implants, Grady's piece reports, with a dozen deaths and 481 of them attributed to Allergen Biocell, according to the FDA, which dragged its heels after first recognizing the link to breast implants in 2011.

The Times story, which notes that the devices were banned months ago in Europe, contends that the "Biocell textured implants carry a risk that is about six times that of other textured implants sold in the United States."

Dr. Binita Ashar

It also reports that Dr. Binita Ashar, director of the FDA's Office of Surgical and Infection Control Devices, said at a news briefing…about the recall" that "hundreds of thousands of women in the United States have Biocell implants." 

The article also quotes Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, as saying that "the data regarding deaths was particularly informative of our decisions."

Main symptoms of the disease "are usually swelling and fluid accumulation around the implant," Brady writes.

FDA officials reportedly are considering "adding a black-box warning [to the labeling of the breast implants] to draw attention to the risks, and requiring doctors and patients considering the surgery to go over as checklist to help women understand the benefits and risks of the devices."

More information about implants can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.