STORY FROM: Drugs & Medical Devices
FDA Issues Warning Letters to Breast Implant Manufacturers Allergan, Ideal Implant
May 18, 2020
WASHINGTON, D.C. — The Food and Drug Administration has issued a warning letter to Allergan Inc., accusing it of failing to conduct post-approval studies for its silicone gel-filled implants as required by premarket approval orders.
In a May 14 letter, the agency noted several serious deficiencies in Allergan’s post-approval study to evaluate its Natrelle silicone gel-filled breast implants (“Round Responsive implants”) and Natrelle 410 Highly Cohesive Anatomically Shaped silicone-filled breast implants (“Style 410 implants”).
“The post-approval study group of subjects with Round Responsive implants has shown poor recruitment and follow-up rates,” the FDA contends. “Allergan’s failure to ...