Allergan Warned for Postapproval Studies for Breast Implants
Allergan has received a warning letter from the FDA for serious deficiencies in a postapproval study of two of its Natrelle brand breast implants.
The agency described the low recruitment and follow-up rates for the postapproval study of the Natrelle Round Responsive and Style 410 implants as “unacceptable.”
Both products were recalled last year because of a potential link to anaplastic large-cell lymphoma. Manufacturers of silicone gel-filled implants must conduct postapproval studies for safety and effectiveness even if an implant has been recalled.