FDA pushes back on silicone breast implant study

The FDA last week pushed back at a large study showing an association between silicone breast implants and some rare diseases, standing by its record of warning the public about their risks – despite granting approvals to a slew of the implants in recent years. The study, published Sept. 14 in the Annals of Surgery, looked at data from nearly 100,000 breast implant procedures the researchers gleaned from FDA-mandated post-approval studies for implants made by Johnson & Johnson (NYSE:JNJ) unit Mentor and by Allergan (NYSE: AGN). The analysis showed that silicone implants are associated with higher rates of Sjögren syndrome, scleroderma , rheumatoid arthritis, stillbirth and melanoma. There was one reported case of BIA-ALCL and no association with suicide. The risk of rupture over the short term was higher for saline implants at 2.5%, compared with0.5% for silicone implants, but capsular contracture for the silicone implants was 5.0% compared with 2.8% for saline-filled implants. “Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants,” the researchers wrote. In an editorial published alongside the study results, Dr. Binita Ashar, director of surgical devices at the bureau’s Center for Devices & Radiological He...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Women's Health Allergan johnsonandjohnson Source Type: news