FDA: Breast implants need higher warnings due to cancer risk

The Food and Drug Administration on Wednesday recommended intensified warnings for women considering breast implants, citing “new information” about risks associated with the products.

The agency, under siege from women who say they have been harmed by implants, is recommending “boxed warnings” generally used to alert consumers and health care providers to serious risks associated with drugs or medical devices.

The FDA says breast implants have been linked to, among other things, a rare type of cancer of the immune system. The non-Hodgkin’s lymphoma is generally found in the scar tissue and fluid near the implant, but in some cases can spread throughout the body, the FDA says.

“An individual’s risk of developing (cancer) is considered to be low,” the FDA said. “However, this cancer is serious and can lead to death, especially if not treated promptly.”

The most common symptoms are persistent swelling, presence of a mass or pain in the area of the breast implant that may occur years after implant placement, the FDA said.

Another issue, called breast implant illness, involves systemic symptoms such as fatigue, memory loss, rash, “brain fog” and joint pain, the FDA said. The relationship between the symptoms and the implants is unclear, the agency said.

Dr. Oren Lerman, a plastic surgeon in New York City, says tens of thousands of women have complained of breast implant illness, which continues to mystify physicians.

“We absolutely need more information on that,” said Lerman, director of Lenox Hill Hospital’s Aesthetic and Reconstructive Breast Surgery Fellowship.

Issues with breast implants were highlighted in March during two days of FDA public advisory hearings involving women, surgeons and manufacturers. The hearings came about following FDA reports indicating hundreds of women with textured breast implants had been diagnosed with the rare cancer. Several of them died.

Manufacturers presented data indicating the vast majority of problems involved implants that were 6 years old or more.

In July, Allergan agreed to a global recall of its Biocell textured breast implants and tissue expanders because of reports of cancer-related deaths.

Amy Abernathy, the FDA’s principal deputy commissioner, said Wednesday that the agency “heard loud and clear from the public advisory panel meeting” that more must be done to protect women.

“We have heard from many women that they are not fully informed of the risks when considering breast implants,” she said.

The FDA recommends that manufacturers identify risks in the boxed warning, including that breast implants are not lifetime devices; the chances of developing complications increase the longer a patient has the implant, and additional surgery may be required to address the complications; and that breast implants have been associated with the risk of developing the rare cancer and may be associated with the systemic symptoms.

“I think it’s necessary and I think it’s a good idea,” Lerman said. “The problem is, when was the last time a patient read (or) looked at the label on their implant? The way to get the information across is discussion with the patient.”

The FDA is listening, and also has proposed that manufacturers include a checklist for patients to discuss with their surgeons weighing the risks and benefits of the implants.

The recommendations were released in draft form to allow for 60 days of public comment before they are finalized. About 400,000 U.S. women get breast implants each year, about a quarter of them after cancer surgery.

Previously, the FDA recommended that labeling include the methods and frequency of screening for rupture, and current approved labeling recommends MRI screenings for patients beginning three years following implantation and every other year thereafter.

The new recommendations propose that patients without symptoms be screened using either ultrasound or MRI five to six years following implantation and then every two years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.

“Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants (and) help patients better understand breast implant benefits and risks,” Abernathy said.

Read more at usatoday.com.