Textured Breast Implants That Have Been Linked To Unusual Cancer To Be Recalled Globally
The recall in the United States was at the request of the FDA, which said that more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The agency is not recommending women with the implants have them removed because the cancer is so rare.
The New York Times:
Breast Implants Linked To Rare Cancer Are Recalled Worldwide
Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and Drug Administration, and will also be recalled globally, the agency announced on Wednesday. The F.D.A. decision, based on an increasing number of cases and deaths from the implant-associated cancer, lags far behind action in Europe, where the Allergan devices were effectively banned late last year. (Grady, 7/24)
The Associated Press:
Breast Implant Recalled After Link To More Rare Cancer Cases
The FDA is not recommending women with the implants have them removed because the cancer is so rare, but say they should check with their doctor if they have symptoms, which include pain and swelling. Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Those models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface. (Perrone, 7/24)
The Washington Post:
Allergan Said It Acted After Getting New Data On Illnesses And Deaths From The FDA
The FDA said the new data shows that 573 cases worldwide have linked the rare cancer to the implants since the agency began tracking the issue in 2011. The vast majority of those cases involve Allergan products. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Of those fatalities, authorities identified the implant manufacturer in 13 cases — and it was Allergan in all but one. (McGinley, 7/24)
The Wall Street Journal:
Allergan Recalls Breast Implants After FDA Cites Lymphoma Link
“While the overall incidence appears to be relatively low, once the evidence indicated the Allergan product was linked to patient harm including deaths, the FDA took action,” Amy Abernethy, the FDA’s principal deputy commissioner, said on a conference call with reporters. “We know that today’s news will be alarming to patients with breast implants.” (Loftus, 7/24)
NPR:
Textured Breast Implants Linked To Rare Type Of Cancer Are Recalled
It's not clear whether the texturing is actually responsible for the cancer or is just associated with a higher incidence of the disease. But Maman and others say the surface can interact with the surrounding scar tissue that the body forms as an immune response to the implant. "It's that response that is believed to cause the formation of the lymphoma," Maman said, noting that he only uses smooth, round implants. Given the risks linked to textured implants, he said, "taking them off the market is very prudent and the right approach." (Aubrey and Laidlaw, 7/24)
USA Today:
FDA Recalls Allergan Textured Breast Implants Linked To Rare Cancer
Dr. Elisabeth Potter, a plastic surgeon in Austin, Texas, has cared for women with cancer after receiving textured implants. She says the recall is an important step to protect women from the potential risks of textured implants. "It was influenced by folks speaking up when the FDA didn’t act quickly enough," Potter says. "The power is now back in a woman’s hands, and the FDA is backing her up." Potter says women with textured implants should talk with their doctors and monitor for any symptoms such as pain, swelling, redness or anything abnormal. (Alltucker, 7/24)
The Hill:
Allergan Recalls Textured Breast Implant Linked To Rare Cancer
The products have already been banned or recalled from the market in other countries. (Weixel, 7/24)
