Saline Breast Implant Re-Operations Noted

[WASHINGTON, DC] - More than a quarter of women who receive saline implants to increase the size of their breasts will undergo another breast operation within five years, according to studies presented yesterday at a Food and Drug Administration advisory committee hearing.

While the most common reason for the additional operations is to select a breast of a different size or shape, two-thirds of the women needed more surgery to correct problems ranging from leakage and wrinkling to deflation of the implanted device and tightening of the scar tissue around the implant.

The new information was presented by the two companies approved to manufacture saline breast implants, Mentor Corp. and Inamed. The FDA required the follow-up studies after approving the implants in 2000, despite protests from critics who said there was not enough information to prove they were safe.

Although the FDA panel of experts was not asked to make recommendations to the agency, as advisory committees usually are, some members expressed serious concerns about both the results presented and the nature of the studies.

Amy E. Newburger of the White Plains Hospital Center in New York criticized Mentor in particular for its "mind-boggling poor results" and "high rates of product failure," and Michael Choti of the Johns Hopkins
School of Medicine called the company's data "astoundingly weak."

Public speakers also criticized Mentor for past manufacturing practices, and the FDA informed Rep. Roy Blunt (R-Mo.) this month that a long-standing criminal investigation of the company "is still ongoing." The agency did not comment on the focus of the investigation.

The FDA panel was considerably more positive about the Inamed studies, which had been able to track 80 percent of the patients enrolled in an earlier study. Mentor had been able to track about 50 percent from its previous studies.

The panel members voiced generally strong support for keeping breast implants available, saying women should have the right to choose the operation. But they also said they did not think women are well informed about the risks of the procedure and the chances that they will need further surgery to repair and maintain implants.

The issue of breast implants has been contentious for years. The FDA banned silicone gel implants in the early 1990s because of health concerns, but it came under strong criticism from breast cancer patients and others for that decision.
Silicone implants are still allowed only under limited conditions, but saline implants were never removed from the market and have become popular, especially since the FDA gave them its retroactive approval in 2000. The agency has said it will consider new applications to approve silicone gel implants.