On March 19 the Food and Drug Administration (FDA) issued letters of warning to two US breast implant manufacturers, Mentor Worldwide LLC and Sientra Inc.
The letter to Mentor Worldwide LLC raised concerns regarding several serious deficiencies in the post-approval study for its MemoryShape implants, poor follow-up rates with patients in the study and failure to enroll the required number of patients that took part. The FDA also stated that there were significant data inconsistencies.
The FDA’s warning letter to Sientra Inc. suggested there was a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants and implied that the manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61%, which is below the target follow-up rate.
The authoritative body has requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. Failure to comply may result in the FDA taking action, including pursuing applicable criminal and civil penalties, the statement suggests.
FDA commissioner Scott Gottlieb commented, “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”