FDA Issues Warnings To Two Manufacturers Of Breast Implants
The U.S. Food and Drug Administration (FDA) just issued warning letters to two manufacturers of breast implants for failing to comply with regulatory requirements. The FDA sent a warning letter to Allergan for failure to comply with requirements to conduct post-approval studies assessing the risks and long-term safety of two separate breast implant models. Both breast implant models were voluntarily recalled last year. The FDA also sent a warning letter to Ideal Implant Incorporated. That letter was sent for failing to comply with adverse event reporting requirements and current good manufacturing practice requirements. The letter was prompted by an inspection which was conducted earlier in 2020.
The FDA’s letter to Allergan noted numerous problems with Allergan’s post-approval study evaluating its NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants and its NATRELLE Silicone Gel-Filled Breast Implants. The study of the latter suffered from poor follow-up rates subjects and poor recruitment in its study group.
“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk of breast implant associated anaplastic large cell lymphoma. The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable,” said Binita Ashars, M.D. of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health.
The FDA’s letter to Ideal noted that Ideal’s implants were adulterated because of failure to maintain proper files for device complaints, failure to maintain and establish the right procedures for implementation of preventative and corrective actions and failing to maintain and establish the right criteria for the testing of finished devices. The FDA also says the products were misbranded since Ideal failed to provide reports of device malfunctions in a timely manner to the FDA. These malfunctions could result in serious injury or death.
Allergan’s BIOCELL textured breast implants and tissue expanders were recalled in 2019. These products were associated with a sixfold increase in risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) development compared to other textured implants. The FDA said that, at the time, 481 out of 573 worldwide BIA-ALCL cases involved Allergan implants, and that 12 out of the 13 BIA-ALCL deaths with a known implant manufacturer involved Allergan breast implants. The FDA had previously released alerts regarding BIA-ALCL in 2011 and 2017.