Breast Implant Makers Land in Hot Water with FDA

FDA took action Thursday that proves the agency is still keeping close tabs on the breast implant market, which has long been plagued with safety and regulatory problems. FDA sent warning letters this week to Allergan and Ideal Implant failure to comply with various regulatory requirements. In Allergan's case, the Irvine, CA-based company has allegedly failed to comply with post-approval study requirements to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. In Ideal Implant's case, the Dallas, TX-based company allegedly failed to comply with current good manufacturing practice requirements and adverse event reporting requirements following an FDA inspection conducted earlier this year. The warnings letters are similar to those issued last year 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. Every manufacturer of FDA-approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate the safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. Generally, a manufacturer must still comply with post-approval requi...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Implants Source Type: news