Nine deaths from a very rare kind of cancer have been linked to breast implants, indicating a very low but increased risk in women with implants, according to the U.S. Food and Drug Administration.
The FDA said it now agrees with the World Health Organization, which concluded years ago this type of lymphoma can develop following breast implants. Concerns were first raised at the FDA in 2011, but the agency said then that there were too few cases to know if there was a connection.
In an update on Tuesday, the agency said it had received 359 reports of the cancer in women with breast implants, but cautioned that such reports are often missing key details, unconfirmed or duplicated.
The FDA and doctor groups said women who have implants shouldn't panic, and there is no need to have their implants removed. Women should continue with their routine follow-up, but contact their doctor if they have lingering pain or swelling around the implant, particularly years after the surgery.
The cancer is not breast cancer, the FDA emphasized. It is called breast implant-associated anaplastic large cell lymphoma and mostly occurs in a capsule of tissue that develops around the implant. This type of cancer usually progresses slowly and most patients are readily treated with surgery to remove the implant.
On average, the cancer occurs eight years after a woman gets an implant, according to the American Society of Plastic Surgeons. It noted only about 10 new cases are reported worldwide each year.
In most cases, the cancer was found during surgery to remove or replace an implant after the women reported pain, lumps and swelling around it. That seems to occur more often with textured implants — rather than ones with a smooth surface — but many reports didn't include that information, the FDA said.
The reports also often omitted the type of implant. In those reports that did, about 60 percent of the cases involved silicone gel implants and the rest saline, according to the FDA.
Since 2011, packaging for all implants sold in the U.S. and Canada has listed the possible cancer risk, and advises women to discuss all the risks and options with their doctor.
AP Medical Writer Maria Cheng in London contributed to this report.
Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma