Plastic surgeons respond to FDA concerns
ARLINGTON HEIGHTS, Ill. – Plastic surgeons can reduce breast implant re-operations in augmentation patients to 3 percent by following a new system of decision and management algorithms, according to a study published in Plastic and Reconstructive Surgery® (PRS), the official medical journal of the American Society of Plastic Surgeons (ASPS). At the same time, these algorithms can raise patients' safety and overall satisfaction, the study also found.
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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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