The U.S. Food and Drug Administration has issued warning letters to Sientra Inc ...
- The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson & Johnson unit for failing to comply with the post-approval study requirements for their breast implants.
The agency’s letters, dated March 18, highlighted issues in the companies’ post-approval studies, which included evaluating the long-term performance and safety of the implants, used for breast augmentation and reconstruction procedures. Sientra had reported poor patient follow-up rate of 61 percent for the post-approval study of its Silicone Gel Breast Implants, which required the company to evaluate the study subjects annually for 10 years, according to the FDA letter.
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