FDA warns J & J, Sientra over lack of post-approval silicone gel breast implant studies

The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee. In its letter to J&J’s Mentor, the FDA noted a failure to enroll the appropriate amount of patients in the post-market study of its MemoryShape breast implant which won approval in 2013. The federal watchdog also said that Mentor had poor follow-up rates with patients and noted significant data inconsistencies in the report, including poor patient accounting and missing race and ethnicity data. In its letter to Sientra, the federal watchdog knocked the company on its 61% follow-up rate, which falls below the target for the post-market study. The agency said that both companies’ failure to address the raised concerns and comply with the post-approval study requirements violates its pre-market approval order. The FDA gave both companies 15 days to comply with the warnings. “Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regul...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Women's Health johnsonandjohnson Mentor Worldwide Sientra Source Type: news