As new evidence surfaces about the potential dangers of breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and other reported breast implant injuries, like pain, swelling, and rupture, more people are beginning to take notice. There have been upwards of 600 cases of BIA-ALCL worldwide and at least 457 cases in the U.S. alone. At least 16 women have died of the disease, including nine in the U.S.
In November, 2018, French regulatory officials asked Allergan to recall their textured breast implants in the 33 countries where they were sold. In April, 2019, France went a step further and banned all textured implants, which made up about 80 percent of the breast implant market there.
The FDA has been researching breast implant risks and the reports of breast cancer illness for decades. In light of the recent cancer scare, however, the administration has dug deeper into investigating some of the claims to see whether they should also ban textured implants.
However, the FDA at this time does not believe the risks associated with textured breast implants warrants a national ban on any particular breast implant product or on breast implants in general. While the cancer risk has been confirmed, it is also rare, and the evidence for other implant-related illnesses are mostly anecdotal and not definitive.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard,” Dr. Jeffrey Shuren said in a statement.
For many, this won’t come as a surprise, as the FDA has only banned two medical devices in its entire history. In lieu of a ban this time, the FDA is still considering adding bold warnings to breast implants and creating stricter requirements for reporting problems. It will also require breast implant manufacturers to report all serious injuries, malfunctions, and deaths related to their devices rather than summarizing them in one quarterly report.
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To date, the FDA has received more than 350,000 reports related to breast implants, but only about 1/7th of these cases are searchable on the FDA’s public database. To people like Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports, this is a huge problem.
“If there’s a pattern of more than 300,000 malfunctions and non-serious injuries, those should be available to the public, and let them decide if they’re serious,” Tomes said.
To many, failing to ban textured implants seems like an unwise move. However, it’s possible that the global cancer scare issue alone could help phase out textured implants in the U.S. without a ban.
“I think a lot of physicians are going to avoid them and patients are going to say they don’t want them,” said Diana Zuckerman, president of the National Center for Health Research.
The vast majority of BIA-ALCL cases occur in women whose implants are textured to prevent slippage and minimize scar tissue. These types of implants only make up about 10 percent of the U.S. implant market, which may be part of the reason the FDA didn’t ban them. Cases of BIA-ALCL have been reported, however, in women with smooth implants.
An estimated 10 million women worldwide have breast implants. Many of these women will never experience any problems, but it’s good to be on the lookout. If you have any of the symptoms of potential breast implant illness or notice any changes in your breasts, please contact your doctor.Whizzco