Researchers from Magee Womens Hospital, part of the University of Pittsburgh Medical Center (UPMC), are evaluating a new kind of silicone breast implant for women who have undergone breast cancer surgery.

"For a great many American women, breast reconstruction provides a tremendous psychological, physical and emotional uplift following breast cancer surgery," said Dr. Kenneth Shestak of UPMC, the principal investigator of the study. "And for many more, breast augmentation may lead to a more fulfilling life through better confidence and an improved self-image."

The study is designed to examine the safety and efficacy of the new CoheSIL implant, manufactured by McGhan Medical, which contains a silicone gel and has a more durable casing than previous implants.

"Silicone has been considered by many plastic surgeons to be a more desirable alternative to saline implants for breast augmentation and reconstruction," said Shestak, who is the interim chairman of the division of plastic surgery at the University of Pittsburgh School of Medicine.

In the late 1980s, safety concerns prompted litigation regarding silicone breast implants, and eventually led to their withdrawal for use in routine breast augmentation in the United States in 1992. However, Shestak said that links between the implants and a variety of health problems have been disproved by large collaborative studies of the medical literature in the United States and the United Kingdom. The U.S. Food and Drug Administration has designated the implants as Class III medical devices, subject to FDA approval.

Shestak reiterated that a review of virtually all studies published in peer-reviewed medical journals supports the safety of silicone implants. Current studies also find no connection between the use of a silicone implant and any known disease in humans, he said.

Shestak added that the National Academy of Sciences' Institute of Medicine (IOM) reported in 1999 that a similar study review failed to find a basis for health concerns regarding silicone implants. "In the evaluation of epidemiological data, the IOM report indicated that immunological diseases, cancer, neurological and other systems conditions did not appear to be increased in women with breast implants when compared to women who did not have implants," he said.

A total of 940 patients will participate in the study at 47 centers nationwide, with about half enrolled for augmentation and the remainder scheduled for reconstruction or revision surgery. The study participants will be followed at specific time intervals over a 10-year period to determine the performance and durability of the implants.

SOURCE:
University of Pittsburgh Cancer Institute (http://www.upci.upmc.edu)