System Lowers Breast Augmentation Re-operation Rate By 17 Percent; Plastic Surgeons Respond to FDA Concerns
For Immediate Release: November 10, 2004
During the U.S. Food and Drug Administration (FDA) advisory panel hearings on silicone breast implants in October 2003, panelists expressed concern about the manufacturer's reported 20 percent re-operation rate for silicone breast implants.
"Although plastic surgeons began to use saline implants after silicone implants were banned by the FDA, the re-operation rates for primary breast augmentation have remained largely unchanged for more than a decade," said John Tebbetts, MD, ASPS member and study author. "We originally created these algorithms to help manage potential problems and educate patients about the benefits and risks of breast augmentation. What we also found was that the algorithms significantly reduced the rate of re-operation, increased patient safety and made patients happier about the results of their procedure."
Directly responding to the FDA's concerns, a group of board-certified plastic surgeons formed the Breast Augmentation Surgeons for Patients Initiative (BAPSI). They adopted the algorithms from Dr. Tebbetts' practice and expanded them to address a number of clinical situations, including re-operations to change the size of implant, capsular contracture, infection, implant displacement and silent rupture of silicone implants.
According to the study, using algorithms, step-by-step problem-solving procedures for surgical situations, reduced the overall re-operation rate to 3 percent in 1,662 reported cases over seven years. The algorithms measure five critical characteristics to help determine the right implant and procedure for the patient: base width of the breast tissue, degree of stretch, nipple-to-fold distance, implant dimensions and how the implant will sit within the breast.
"These algorithms have been shown to reduce unnecessary re-operations, such as exchanging implants for larger ones, by providing plastic surgeons with comprehensive guidelines for successful and safe surgeries and providing patients with more definitive information about the risks and benefits," said Dr. Tebbetts.
"In addition, rather than reinventing the wheel each time similar problems occur, these algorithms have provided us with a set of standards that are designed to help produce optimal results and ensure patient safety," said Dr. Tebbetts.
More than 254,000 women had breast augmentation in 2003, making it the second most popular cosmetic plastic surgery procedure for women, according to the ASPS. Since 2000, the procedure has grown in popularity by 20 percent.
For referrals to ASPS member plastic surgeons certified by the American Board of Plastic Surgery and to learn more about cosmetic and reconstructive plastic surgery, call the ASPS at 888-4-PLASTIC (888-475-2784) or visit www.plasticsurgery.org.
ASPS is the largest organization of board-certified plastic surgeons in the world and the foremost authority on cosmetic and reconstructive plastic surgery. With nearly 5,000 members, more than any other plastic surgery organization, ASPS is the definitive voice of the plastic surgery specialty. Viewed throughout the world as the pinnacle of information for new techniques, advances and plastic surgery trends, the society represents 94 percent of all the board-certified plastic surgeons in the U.S. Ninety-four percent of all ASPS members perform cosmetic plastic surgery and 89 percent of all ASPS members perform reconstructive plastic surgery. ASPS, founded in 1931, represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.