- FDA served warning letters to two breast implant manufacturers on Thursday, the latest development in an ongoing dialogue between regulators, patient groups, the device industry and plastic surgeons addressing safety issues that have plagued the products.
- The agency said Allergan failed to comply with postapproval study requirements for two models of breast implants it voluntarily recalled from the market last year at FDA's urging. The agency also took issue with a much smaller company, Ideal Implant, following inspections in January and February that found deficiencies in satisfying good manufacturing practices and adverse event reporting requirements.
- With Thursday's citations from FDA, every manufacturer with breast implants allowed for sale in the U.S. market has now received a warning letter within the last 14 months.
Adverse health outcomes tied to breast implants have become one of the highest-profile medical device safety stories in recent years.
FDA and regulators around the world have documented more and more cases of a form of lymphoma that can develop around implants known as breast implant associated anaplastic large cell lymphoma, or BIA-ALCL. Some women have also reported breast implant illness, a term first used by patient groups that FDA now acknowledges, encompassing a range of poorly understood systemic symptoms believed to be linked to the devices.
Breast implants are Class III devices, necessitating premarket approval. FDA requires all silicone gel-filled breast implant makers to conduct postapproval studies "to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer." Numerous companies have failed to adequately carry out those studies, according to the agency.
Days before holding a widely attended two-day advisory committee meeting on breast implants last March, FDA issued warning letters to Mentor, a J&J subsidiary, and medical aesthetics company Sientra. Both letters addressed deficiencies with required postmarket studies, citing low recruitment, poor data, and low follow-up rates. Neither warning letter has been closed out, according to FDA's database.
Following that meeting, the agency last summer asked Allergan to initiate a voluntary recall of certain textured breast implant models linked to higher rates of cancer. According to a quarterly report filed by Allergan on May 7, its first-quarter breast implant revenues of just over $45 million declined more than 37% from the prior year. In that same filing, Allergan said company subsidiaries are defendants in approximately 48 cases, including several class actions, alleging the company's textured breast implants caused women to develop BIA-ALCL.
In October, the agency issued draft guidance recommending a black box warning among other new labeling additions for the devices.
Thursday's letter to Allergan alleges "several serious deficiencies" in the company's evaluation of two implant models. "The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable," FDA's letter said. In the case of Ideal Implant, which makes saline-filled breast implants, FDA allegations included that the company failed to maintain proper files for device complaints it received from customers.
The Center for Devices and Radiological Health alone has now issued 10 warning letters so far this year, according to FDA's warning letter database. The center sent 12 total warning letters in 2019.
Neither Ideal Implant nor Allergan, now part of AbbVie under a deal finalized May 8, could be reached for comment.