March 01, 2000 02:58pm
Regulators Seek to Determine Safety of Saline-Filled Implants
by: Lauran Neergaard
(GAITHERSBURG, MD) -- Federal regulators opened scientific hearings Wednesday to determine if saline-filled breast implants are safe enough for thousands of women to continue getting - or if they break open and deflate too often.
Some 9.2 percent of saline-filled implants given to breast cancer patients ruptured and deflated within three years of implantation, manufacturer Mentor Corp. told a Food and Drug Administration meeting.
That risk was three times greater for breast cancer patients than for women who had their breasts enlarged cosmetically, the study of 1,680 implant recipients found.
In addition, 40 percent of cancer patients who received saline implants needed some repeat surgery within three years, and 24 percent of these implant recipients suffered breast hardening from scar tissue, a complication that can be very painful.
For cancer patients whose first implant deflated, Mentor said the chance a second implant would break was 22 percent, the company said.
Data on the risks of saline-filled breast implants has long been awaited. About 130,000 American women received saline implants last year, even though the FDA never has declared them safe.
Saline implants currently are sold because of a government loophole: They hit the market before the FDA began regulating medical devices.
These implants are the only option for most women seeking breast reconstruction or cosmetic breast enlargement. In 1992, the FDA banned silicone gel-filled implants except for a small number of women in strict clinical trials.
The FDA now is reviewing saline implants to decide if they are safe enough to continue selling and, if so, how to make sure women understand that - despite what many plastic surgeons now claim - their implants are not guaranteed to last a lifetime.
About a dozen women, some angry and some tearful, urged the FDA to declare the implants dangerous and defective. Some held up implants removed from their bodies that were blackened with fungus, and blamed them for causing infections, excruciating breast pain or repeated surgeries.
The implants may have a higher failure rate than any other medical device FDA lets sell, said Dr. Norman Anderson of Johns Hopkins University.
"Only fools will call these risks acceptable," said Patricia Faussett of Henderson, Nev., who said her illnesses disappeared once her implants were removed.
But some breast cancer patients happy with saline implants called them vital to emotional recovery after a mastectomy. "It has given me back my self-esteem and sexuality," said Jennifer Gardner of Washington.
Tens of thousands of women in the 1990s claimed implants gave them serious diseases, from arthritis to cancer. But after repeated scientific studies, the prestigious Institute of Medicine last year declared that breast implants, whether silicone gel- or saline-filled, do not cause major diseases.
The FDA always has considered saline implants less risky simply because if they break, they release salt water into the body, not a foreign substance. But officials are concerned about how often the implants break or cause local complications.
In addition, University of Maryland radiologist Dr. Wendie Berg told the FDA it is significantly harder for mammograms to detect breast cancer when the X-rays have to penetrate breast implants.
"We provide a safe and effective option for women," responded Mentor vice president Bobby Purkait.
Mentor cited studies that found no cancer diagnosis problems, and contended many women have repeat surgeries because they want bigger implants or are upset that one breast turned out larger than the other.
Implants were riskier for cancer patients because they already were in poor health, prone to infections and undergo repeated breast exams and treatments that could stress the implant, company officials said.
In contrast, 3.3 percent of the implants used in cosmetic breast enlargement broke and deflated within three years, Mentor said. Some 6.9 percent of the cosmetic patients had hardened breast tissue and 1.7 percent infections.