Allergan announced a worldwide recall of textured breast implants Wednesday after the Food and Drug Administration found a sharp increase in a rare cancer and deaths linked to the devices and asked the company to pull the products off the United States market.
The Dublin-based company said it was recalling BIOCELL textured breast implants and tissue expanders from all markets in which they are sold. The devices had already been banned or recalled in several countries.
The FDA said the new data shows there have been 573 cases worldwide linking the rare cancer to the implants since the agency began tracking the issue in 2011. The vast majority of those cases involve Allergan devices. 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 33 fatalities, authorities identified the implant manufacturer in 13 cases – and it was Allergan in all but one.
In February, the last time the FDA updated its numbers on implant-associated illness, it reported 457 cases and nine deaths worldwide.
The agency said Wednesday that the latest data indicates the risk of such disease is six times greater with Allergan BIOCELL textured implants than with other types of textured implants sold in the United States.
The FDA’s new stance against the BIOCELL product is a reversal of its posture a few months ago, when it said there was insufficient evidence to try to remove the devices from the market.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said on a press call the agency changed its position partly after seeing the sharp increase in reported deaths.
Allergan pulled the devices off the European market last year. Canada banned the devices in May after finding an increased risk of cancer.
The vast majority of implants used in the United States have a smooth surface. Textured devices make up only about 10 percent of the U.S. market, with the Allergan textured devices accounting for less than five percent, agency officials said. The shell of textured devices has a slightly roughened surface designed to keep the implant in place.
Shuren said the agency is not able to say there is no risk posed by smooth implants; there have been some reports of illnesses also linked to those devices. But he said the risk is higher with textured implants and even higher with the Allergan BIOCELL model.
Amy Abernethy, the FDA’s principal deputy commissioner, said that although the overall incidence of implant-linked disease appears to be relatively low, “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”
The officials said they do not recommend that women who do not have symptoms – such as pain and fluid around the implant site – have their implants removed.
Diana Zuckerman, president of the National Center for Health Research, a nonprofit organization, welcomed the FDA’s decision to press Allergan to recall the implants. “We are very glad they have done it,” she said. “I think they could have done it months ago and I hope a lot of women have not been getting these implants in the meantime.”
The FDA said that in most cases, the rare lymphoma linked to the implants is found in scar tissue and fluid near the device, but that in some cases it can spread throughout the body. The condition can be life-threatening if it isn’t diagnosed and treated promptly, the agency said. Most patients are treated successfully by surgery to remove the implant and scar tissue but some may require chemotherapy or radiation.
Scientists are not sure why certain textured implants might be a factor in the development of the rare cancer. “We don’t know what it is that might increase the risk,” said Binita Ashar, director of the FDA’s office of surgical and infection control devices.
The agency said its data on the rising incidence of illnesses and deaths related to the implants came from medical device reports and searches of the medical literature.
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