Myrl Jeffcoat wisgroup_leader@yahoo.com

By Angelica Oung

STAFF REPORTER

Sunday, Sep 23, 2007, Page 2

A committee of specialists assembled by the Department of Health (DOH) decided on Friday not to approve cohesive gel silicon breast implants until the manufacturers can prove that the implants, which sometimes rupture, are safe.

Cosmetic surgeons have been calling for approval of the new class of silicon implants, which they say are safer than liquid silicon implants.

According to figures provided by Mentor Corp to the DOH, 0.5 to 7.7 percent of women who have received "Memory Gel" breast implants have suffered ruptures and 8.1 to 18.9 percent have suffered capsular contracture.

Capsular contracture is a common complication of breast augmentation surgery in which the body reacts to the implant by forming a tight tissue lining encapsulating it, which is painful and causes the breast to become hard and abnormal in shape.

In addition, 15.4 to 19.1 percent of women had to undergo a secondary surgical procedure after their breast augmentation with the product. The company's figures derive from an in-house study done between 2001 and 2004.

"We have to evaluate the evidence carefully," said the deputy head of the bureau of pharmaceutical affairs, Liu Li-ling. "This is not a product associated with immediate medical necessity."

Liu said that more information is needed from the manufacturers, including information from 2004 to this year. There are no immediate plans to convene another committee to meet on the matter.

Prior to the committee hearing, Taiwan Society of Aesthetic Plastic Surgery director Lin Chin-yun told the media that since cohesive gel silicon implants are not liquid but a cohesive mass, there is less danger associated with their use.

"There is no risk of leakage, even in the event of a rupture," Lin said earlier this month.

However, a case report published in the Journal of Plastic, Reconstructive & Aesthetic Surgery in August last year detailed the case of a 45-year-old woman whose gel implant ruptured and leaked silicon into her body, resulting in silicone lymphadenitis.

"High cohesive gel implants may not be as safe as is commonly believed," the case report said.