FDA issues warning letter to breast implant manufacturers
Published
16th Apr 2019
The US Food and Drug Administration (FDA) has issued letters of warning to two breast implant manufacturers – Mentor Worldwide regarding its MemoryShape implants and Sientra regarding its Silicone Gel Breast Implants. The letters raised concerns regarding deficiencies in the post-approval studies for both companies, including poor follow-up rates with patients.
