FDA on Thursday said it will not at this time ban the use of breast implants linked with hundreds of cases of a rare cancer, though the agency said it is considering requiring stricter warnings for breast implants.
Background: Hundreds of cancer cases likely linked to breast implants, FDA warns
FDA first reported an association between the cancer, called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implants in 2011. BIA-ALCL is not a breast cancer, but rather a type of non-Hodgkin's lymphoma found in scar tissue and fluid near implants. The agency explained, "When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule."
FDA in February warned that there have been hundreds of confirmed cases of the rare cancer, and at least nine patients have died from the disease since 2010. The agency in a letter sent to health care providers wrote that it had confirmed 457 of the 660 unique cases of BIA-ALCL reported worldwide. The agency wrote, "Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL."
However, FDA in the letter noted that a lack of data on the number of individuals who receive breast implants in the United States and internationally has made it difficult to determine the risks associated with breast implants. FDA said most of the limited research to date demonstrates BIA-ALCL occurs in patients who have breast implants with textured surfaces, rather than smooth surfaces.
Still, FDA said BIA-ALCL cases have been reported among patients who have breast implants with smooth surfaces, as well. According to FDA, most medical device reports of BIA-ALCL do not indicate the implants' texture.
FDA says it will not yet ban textured breast implants
FDA in a statement issued Thursday said it will not at this time ban textured breast implants, because there currently is not enough data to support such a ban in the United States as dictated by the Federal Food, Drug and Cosmetic Act. However, the agency said it is "focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low."
FDA said it has taken various steps to "fill the gaps in knowledge" regarding breast implants' link to BIA-ALCL, "including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions." The agency said it also has "heard from patients concerned that their implants may be connected to health conditions involving their immune system's response to these devices, resulting in a variety of symptoms like chronic fatigue, cognitive issues, joint and muscle pain."
FDA noted that although it does not "have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness." As such, FDA detailed "several new steps" the agency is considering to ensure women can access reliable information about breast implants "to make informed decisions."
For instance, FDA said it is:
- Considering requiring a boxed warning on breast implants, which is the strictest type of warning FDA can require;
- Considering requiring breast implants' labels to include a patient decision checklist; and
- Looking at ways to include ingredients on breast implant labels in a way patients will be able to easily understand.
FDA said it also will continue reaching out to health care providers to ensure they are aware of the risks associated with breast implants and work with pathologist to ensure they know about testing for the lymphoma that is specific to breast implants. Further, FDA said it will continue to update the public about new information regarding breast implant risks.
FDA said it also is changing the way breast implant manufacturers must file medical device reports with the agency. FDA said it no longer will allow summary reporting of breast implant medical device reports. Instead, breast implant manufacturers now will have to file individual reports to FDA that the agency will release to the public.
Ban might not be necessary, researcher says
Jamee Cook, co-founder of Breast Implant Victim Advocacy, said she was "very disappointed" FDA did not ban textured breast implants, but commended FDA for the other actions it announced. "They are not moving as far forward as we wanted, but I think they are making an effort to address our concerns," she said.
Diana Zuckerman, who has studied breast implant safety and is president of the National Center for Health Research, also said she was disappointed FDA did not ban textured implants, but she also noted that it might not be necessary to ban the use of textured implants in the United States to phase out their use.
According to FDA, textured breast implants account for less than 10% of the breast implants sold on the U.S. market. Zuckerman said, "I think a lot of physicians are going to avoid them and patients are going to say they don't want them" (Perrone, Associated Press, 5/2; Grady/Caryn Rabin, New York Times, 5/2; McGinley, Washington Post, 5/3; Maidenberg/Burton, Wall Street Journal, 5/2; FDA statement 5/2).
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