Breast implants linked to rare cancer will stay in market, but with bolder warnings, announces FDA
Nine women have lost their lives so far after silicone breast implants triggered BIA-ALCL, a cancer of the immune system, which has also infected many more
Health authorities in the US have announced that they will allow one type of breast implant, that is linked to a rare form of cancer, to stay on the market. They have also said that the risks associated with it do not warrant a national ban. Nine women have lost their lives so far after silicone breast implants triggered BIA-ALCL, a cancer of the immune system, which has also infected many more.
CNN reported that French authorities had issued a rare ban on the implants for this reason last month but the US Food and Drug Administration (FDA) said on May 2 that it was not ready to take the same step. It has, instead, said that it is considering putting bold warnings for the implants and will also require stringent reporting of problems by manufacturers.
The announcement is the latest in the decades-long government effort to manage the risks and complications involved in transplants that can include scarring, pain, swelling, and rupture. The FDA and other regulators around the world have struggled with the recently confirmed link to the rare cancer as well as the thousands of unconfirmed complaints of other health problems attributed to the implants including arthritis, fatigue, and muscle pain.
FDA regulators also said in a statement that while they do not have any definitive evidence that implants cause any of these chronic ailments, women who are considering implants "should be aware of these risks". It is to this end that the agency said it will consider adding a boxed warning and a checklist that describes the various potential harms for patients who are considering getting them.
Dr. Jeffrey Shuren said in a statement: "At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard." The cancer that has been linked to the implants is not breast cancer but lymphoma that grows on the scar tissue surrounding the breasts. Almost all of the confirmed cases involve a type of textured implant that is designed to prevent slippage and minimize scar tissue.
Diana Zuckerman, who has studied breast implant safety, said that a ban may not be necessary to phase out textured ones. Zuckerman, who is the president of the nonprofit, National Center for Health Research, which evaluates studies and conducts its own research, said: "I think a lot of physicians are going to avoid them and patients are going to say they don't want them."
Breast augmentation is currently the most popular form of cosmetic surgery in the US with around 300,000 women undergoing the procedure each year. Another 100,000 women receive implants for breast reconstruction after cancer surgery.
Ahead of a meeting that took place in March, the FDA had revealed for the first time that it had received more than 350,000 reports related to breast implants over the past 10 years. According to Madris Tomes, a former FDA staffer who launched a company to analyze medical device reports, this number was roughly seven times the number of reports in the agency's publicly searchable database.
Tomes said: "If there's a pattern of more than 300,000 malfunctions and non-serious injuries, those should be made available to the public, and let them decide if they're serious."