In Brief: Saline breast implant studies
This article was originally published in The Gray Sheet
Executive Summary
Saline breast implant studies: As of Sept. 30, manufacturers Mentor and McGhan have enrolled 608 and 1329 patients, respectively, in a one-year prospective clinical trial on saline breast implants, according to figures presented by FDA device center Deputy Director for Regulations and Policy Joseph Levitt at the American Society of Plastic and Reconstructive Surgeons' annual meeting Oct. 7 in Montreal. The trials, scheduled to be completed in 1997, are expected to enroll approximately 3,000 patients by December. Mentor also has enrolled a total of 1599 patients (1268 augmentation/331 reconstruction) for a three-year prospective trial on the implants designed to address overall safety and quality of life issues. McGhan has enrolled 925 patients (820 augmentation/105 reconstruction) in the three-year trial...