Allergan has faced intense scrutiny over the last year regarding their BIOCELL textured breast implants. Research indicates that these implants have increased the risk of a woman contracting breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In July of 2019, the US Food and Drug Administration (FDA) requested that Allergan recall these implants. They did so, and these devices no longer being used by surgeons. Now, The FDA as issued warning letters to Allergan for failure to comply with various regulatory requirements regarding another type of breast implant that they manufacture. Here, the nationally recognized product liability firm, Colson Hicks Eidson, wants to discuss what is going on with these implants.
What does the FDA letter to Allergan say?
Every company that manufactures approved silicone gel-filled breast implants is required by the FDA to conduct post-approval studies in order to further evaluate the effectiveness and safety of their products. These studies are designed to answer additional questions about the long-term safety and potential risks of the breast implants that premarket clinical trials would not have had the time to discover or were not designed to answer. Even if a product has been voluntarily recalled, the manufacturer is still generally required to conduct post-approval testing because they need to assess the long-term outcomes for patients who have already had the devices implanted.
The FDA issued a warning letter to Allergan in May 2020 that noted several serious deficiencies in the company’s post-approval study to evaluate its NATRELLE Silicone Gel-Filled Breast Implants (“Round Responsive implants”) and its NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (“Style 410 implants”).
According to the FDA, the post-approval for their Round Responsive implants has shown poor recruitment and follow-up rates.
The FDA gave Allergan 15 working days from the issuance of the letter to provide details about how the company will correct violations, and failure to properly comply with post-approval requirements could result in additional action being taken by the FDA.
In a news release, Dr. BinitaAshar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said that “The FDA imposes post-approval requirements because they are an important tool for ensuring the safety and effectiveness of the medical devices we regulate.”
We can help if you have been injured due to defective breast implants
If you or somebody you love has Allergan breast implants that you believe to be defective, seek legal assistance as soon as possible. The award-winning team at Colson Hicks Eidson has the resources necessary to conduct a thorough investigation into your case in order to secure any compensation you may be entitled to. Allergan has a history of defective breast implants, and they should be held liable if any of their products cause harm to another person. When you need an Allergan breast implant attorney in Florida or anywhere in the United States, you can contact us for a free consultation by clicking here or by calling us at 305-476-7443.