Sientra responds to FDA letter, does not expect matter to impact operations
Sientra announced it has provided an initial response to the FDA related to a post-approval study Warning Letter issued on March 19, 2019 and will provide a comprehensive plan for compliance to FDA within 15 days. The company also issued the following statement: "Sientra takes this matter seriously and will take all necessary steps to address the topic of the Warning Letter issued by the FDA for one of the company's post-approval studies. We are working to fully address the points noted with our study's participant retention, including patient questionnaire completion and additional follow-up office visits. We have employed numerous methods to encourage patient participation and look forward to continuing to work collaboratively with the FDA for a prompt resolution... Sientra looks forward to discussing its plans to achieve compliance at the FDA's General and Plastic Surgery Devices Panel meeting scheduled for March 25-26, 2019." The company noted it believes this matter will not have an adverse impact on its ongoing business or operations.