(Reuters) - The U.S. Food and Drug Administration has issued a warning letter to Sientra Inc for its silicone gel breast implants that were approved by the agency for breast augmentation and reconstruction procedures.
Shares of the company slipped 6.5 percent to $8.62 in afternoon trading.
The agency's letter, dated March 18, comes after the company failed to comply with the post-approval study requirements, which included evaluating the long-term performance of the implants and following the participants of the study annually for 10 years.
Failure to make good the violations may result in the withdrawal of the premarket approval granted to the product, the letter said.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shailesh Kuber)
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Updated Date: Mar 20, 2019 03:05:54 IST