FDA Busts J & amp;J and Sientra Over Breast Implant Compliance

FDA busted two manufacturers of silicone gel-filled breast implants this week for failure to comply with post-approval study requirements. The agency sent warning letters to Irvine, CA-based Mentor Worldwide, a unit of Johnson & Johnson, and to Santa Barbara, CA-based Sientra for deficiencies in each company's post-approval study for silicone breast implant approvals. Breast implants have been a source of contention between patient advocacy groups, industry, and FDA for decades. Implants were banned from the U.S. market from 1992 to 2006, and the devices have been the cause of an overwhelming number of lawsuits. When FDA lifted the 14-year moratorium on silicone breast implants in 2006, each manufacturer was required to conduct six post-approval studies to further characterize the safety and effectiveness of their breast implants and to answer additional scientific questions about the long-term safety of breast implants that the premarket clinical trials were not designed to answer. “Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and lo...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news