(May 2, 2019) The U.S. FDA said yesterday that it won’t ban a certain textured breast implant linked to a type of cancer. The agency has, however, strengthened warnings on textured breast implants.
Related: Breast Implant Lymphoma Warning
The FDA announcement followed a March 2019 safety hearing over breast implants linked with breast implant-associated anaplastic large cell lymphoma. BIA-ALCL is specifically associated with textured breast implants. The FDA said that based on all currently available data, it doesn’t believe these breast implants meet the legal standard to require their banning under the Food, Drug and Cosmetic Act.
Some other countries, however, have banned or restricted sales of some textured breast implants due to BIA-ALCL concerns. According to FDA, implants sold in those markets aren’t sold in the United States.
By comparison, some 80% of breast implants sold outside the U.S. are textured, according to FDA, compared to less than 10% of breast implants in the U.S.. In addition, the type of textured implants banned or limited by foreign regulators represents less than 5% of domestic breast implants.
Cancer, Chronic Fatigue, Joint & Muscle Pain
The FDA vowed it will take steps to improve information about the risks of breast implants and BIA-ALCL with textured implants. The agency also said it will investigate reports of chronic fatigue and joint and muscle pain symptoms some women report from textured breast implants.
Breast Implant Illness
Some women have told the FDA they are concerned about how their immune systems react to their implants. Some women have experienced a variety of symptoms sometimes called “breast implant illness,” said the agency. The FDA, however, said it doesn’t have definitive evidence that implants cause these symptoms, though current evidence supports the notion that these symptoms may be resolved with the implants’ removal.
The FDA said it will explore ways to include product information on the implants’ labels that patients can understand.
Lymphoma Testing, Boxed Warning, Report Filings
The FDA announced, “We also plan to work with the pathology community to educate pathologists about testing for this lymphoma specific to breast implants.” The agency further said it will work with stakeholder groups on any labeling changes, including a possible boxed warning. The agency also said it is changing how breast implant makers file medical device reports. They will now file individual reports with the FDA instead of “alternative summary reporting.”
The FDA said, “This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks.”
The “alternative summary reporting” program, said the FDA, was established in 1997 to review adverse events for well-established risks, but not patient deaths or unusual adverse events. In the case of breast implants, that includes BIA-ALCL, which means the agency was not getting all of the actual data that it really needs to oversee the safety of these implants.
According to the FDA, these individual reports will now be available in the agency’s public database for medical device reports. In addition, the FDA said it will be making past reports public in the coming weeks.
FDA won’t ban Implants linked to Cancer
“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the FDA said.
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by Matthews & Associates