The Food and Drug Administration issued warning letters on May 14 to two breast implant manufacturers: to Allergan for failure to comply with FDA requirements for long-term breast implant patient safety studies, and to Ideal Implant for ongoing manufacturing quality concerns.
The warning letters specified a period of 15 working days in which the manufacturers must respond with plans for correcting the violations. Failure to do this could result in further action taken by the FDA.
The FDA won’t comment on compliance issue details or whether the manufacturers have responded.
Allergan of Irvine, California
In its warning letter to Allergan, the FDA expressed concerns about “several serious deficiencies” and “failure to comply” with required post-approval studies for two models of the company’s silicone gel-filled breast implants which the company recalled worldwide last year due to cancer risk concerns. (Post-approval studies are patient follow-up studies to assess device safety and risk conducted by the manufacturer after a device has gone to market.)
The FDA requires every manufacturer of approved silicone gel-filled breast implants to conduct post-approval studies—even when an implant has been recalled from the market. By failing to meet this requirement, Allergan could not have properly assessed the long-term safety and risks in patients who had already been implanted with these devices.
“The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health at the FDA, said in a news release.
“We are working to hold sponsors accountable for their post-approval study commitments. This is especially true for women’s health issues such as breast implant safety, which we take very seriously,” Alison Hunt, FDA press officer, told MedTruth by email.
In July 2019 at FDA request Allergan issued a voluntary recall of specific models of its textured breast implants due to concerns over risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare type of immune system cancer occurring near breast implants. Several other countries had already issued recalls—that number is now at 38.
Also last year, Allergan was met with a class action lawsuit in which six women claimed the manufacturer had for years “buried” reports which linked the implants to increased cancer risk. Multiple class action lawsuits have since been filed against Allergan.
Ideal Implant of Dallas, Texas
In its warning letter to Ideal Implant the FDA requested that the company “more adequately describe and clarify details about device complaints” and “clarify how it tests a finished product to ensure it meets specifications.”
Ideal Implant’s manufacturing facility was inspected in January, after which the FDA provided observations for corrective action. When Ideal’s corrections were found inadequate, the FDA took further action by issuing the warning letter.