FDA reviews breast implant safety amid cancer concerns
The U.S. Food and Drug Administration is taking a closer look at the safety of breast implants after concerns aboutand other health issues have been raised. At a two-day meeting that began Monday, officials are hearing from medical researchers, plastic surgeons, implant makers, and women who contend they suffered a number of ailments as a result of their breast implants.
The FDA has long said that breast implants are safe, and it is not expected to propose any new restrictions or warnings at this time. However, health officials have been grappling with how to handle the fact that within the last several years, a confirmed link has been established between implants and a rare form of cancer.
The disease in question is not breast cancer, but a form of lymphoma called anaplastic large cell lymphoma, which is slow-moving and attacks the immune system. The link between breast implants and the development of anaplastic large cell lymphoma was first identified by the FDA in 2011. Over time, evidence mounted and in 2016 the World Health Organization determined that the cancer could develop following breast implants.
The majority of data suggests the cancer risk is associated with breast implants that have textured surfaces rather than those with smooth surfaces.
Kimra Rogers wasof breast implant-associated anaplastic large cell lymphoma after noticing a lump under her arm.
“I could feel a mass that was the size of an egg, it was an egg to a lemon [sized], it was very large,” she told “CBS This Morning” in 2017. She learned it was cancer, possibly connected to the cosmetic breast implants she’d had put in 17 years ago.
“I was never informed that I could possibly get cancer. Basically they said they’re 100 percent safe,” Rogers said.
The FDA says the exact number of cases of the disease remains difficult to determine due limitations in the reporting of breast implant sales data. Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000, according to the Associated Press. The cancer is treatable with the removal of implants, though nearly a dozen deaths have occurred.
Additionally, thousands of women have blamed breast implants for a range of other health ailments, including rheumatoid arthritis, pain and chronic fatigue. In documents released before the meeting, the FDA contends “at the present time, there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses.”
“Don’t ignore us. We are real,” Holly Davis, of Charleston, South Carolina, told the AP. Davis, 60, said she experienced chronic pain and other symptoms after receiving silicone gel implants following a mastectomy in 2002. She had them removed in 2017 and learned the implants had ruptured.
The FDA declined a request by Davis and other patients to add a boxed warning that would require manufacturers to give women a checklist of potential harms and complications before undergoing implant surgery.
Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.
The meeting comes a week after the FDA sent warning letters to two breast implant manufacturers for their failure to comply with requirements to conduct long-term studies assessing the safety of silicone gel-filled implants.