New Silicone Implant To Be Used In Clinical Trial.(Brief Article)

2001 DEC 13 - (NewsRx.com & NewsRx.net) -- A new kind of silicone breast implant, which may signal a return to silicone gel implants, will be used in a clinical trial beginning at Magee-Women's Hospital.

The study, which is being undertaken by the University of Pittsburgh Medical College (UPMC) division of plastic surgery, will focus on the CoheSIL implant manufactured McGhan Medical Corp., a Santa Barbara, California-based company that makes both saline- and silicone-filled breast implants.

"For a great many American women, breast reconstruction provides a tremendous psychological, physical, and emotional uplift following breast cancer surgery," said Kenneth C. Shestak, MD, FACS, study principal investigator and interim chairman of the division of plastic surgery at the University of Pittsburgh School of Medicine. "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 implant, which contains a silicone gel and has a more durable casing than previous models.

"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 an associate professor of surgery.

The CoheSIL implant is made of cohesive silicone gel and is encased in a silicone shell that is designed to hold its shape better than the saline implants currently in wide use, according to McGhan Medical Corp., a leading supplier of breast implants. In addition, a textured surface increases tissue adherence to stabilize the position of each implant.

Magee-Women's Hospital is seeking to enroll at least 10 women who are considering breast reconstruction surgery and who will think about receiving the CoheSIL implants. Women who enroll should not have undergone previous implant surgery. Study participants will be followed at specific time intervals over a 10-year period and undergo thorough examination to determine the ...