Exhibit 99.1
Sientra® Issues Statement in Response to FDA Post-Approval Study Warning Letter
Provides Initial Response to FDA
SANTA BARBARA, Calif., March 20, 2019 — Sientra, Inc. (NASDAQ: SIEN), a medical aesthetics company (“Sientra or the “Company”), today announced it has provided an initial response to the U.S. Food and Drug Administration (“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 additionalfollow-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.
Our primary focus has always been, and continues to be, upholding the highest levels of patient safety. Importantly, the totality of our clinical and real-world data, including our10-year Post-Approval Cohort Study (PACS) which included almost 1,800 participants and fully met FDA’s compliance requirements, has confirmed the long-term safety and effectiveness of our products. Our peer-reviewed, open-label PACS study is the largest silicone gel breast implant pivotal trial that has occurred in our industry to date.
Sientra looks forward to discussing its plans to achieve compliance at the FDA’s General and Plastic Surgery Devices Panel meeting scheduled for March25-26, 2019.
As a clinically-driven company, Sientra continues to be a leading contributor of physician education and awareness around breast implant safety, and the Company’s mission is to provide board-certified plastic surgeons, patients and regulatory officials with balanced, evidence-based information.
The Company noted it believes this matter will not have an adverse impact on its ongoing business or operations.
About Sientra
Headquartered in Santa Barbara, California, Sientra is a diversified global medical aesthetics company and a leading partner to aesthetic physicians. The Company offers a suite of products designed to make a difference in patients’ lives by enhancing their body image, growing their self-esteem, and restoring their confidence. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company’s Breast Products Segment includes its OPUS™ breast implants, the first fifth generation breast implants approved by the FDA for sale in the United States, its ground-breaking Allox2® breast tissue expander with patented dual-port and integral drain technology, and BIOCORNEUM® the #1 performing, preferred and recommended scar gel of plastic surgeons(*). The Company’s miraDry Segment, comprises its miraDry® system, which is approved for sale in over 40 international markets, and is the onlynon-invasiveFDA-cleared device for the permanent reduction of underarm sweat, odor and hair of all colors.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous
