Panel Makes Future Research Recommendations

WASHINGTON, June 21 /PRNewswire/ A 13-member panel convened by the Institute of Medicine reported today that "local complications and reoperations have significant implications for the safety of silicone breast implants." The IOM conducted a year-long review of existing research looking at the potential relationship between silicone and systemic illness and the frequency and severity of product failure. The review was sponsored by the National Institutes of Health.

This is the first time a panel of scientists has thoroughly reviewed the health complications associated with product failure. Breast implant manufacturers have consistently ignored the high rate of rupture, citing rupture rates as low as 1%.

"These are faulty devices which rupture and cause serious health problems for women," said Sybil Niden Goldrich, co-founder of Command Trust Network.

The IOM Committee reached the following three major conclusions on local and peri-operative conditions:

1. Complications such as rupture, hardening of the scar tissue, infections, hematomas, pain and reoperation "occur frequently enough to be a cause for concern."

2. As an implant ages the "risks accumulate."

3. Any woman considering breast implantation must be given adequate informed consent on the "nature and relatively high frequency of local complications and reoperations."

The panel also reported that breast implants interfere with breast cancer detection. Breast implants pose a potentially significant risk for women by interfering with mammography and screening of breast tissue for cancer.

Although the committee stated that there is not sufficient evidence of a link between silicone breast implants and systemic disease, they do say that studies on the immunology of silicones have been limited and flawed.

1. Developing reliable techniques for detecting and quantifying silicone in the body's fluids and tissues.

2. A major study tracking the long-term outcomes as well as local complications of silicone breast implants.

3. The development of a national model of informed consent for women considering breast implantation, the effectiveness of this model should be monitored.

The IOM conclusions reflect a growing concern over serious complications which require additional surgeries. In the most recent issue of the Journal of Biomedical Material Research, a University of Florida research team report that on average 30 percent of implants failed within five years and 70 percent after seventeen years. This review indicates "that the prevalence of failure and other local complications is many times higher than suggested only a few years ago," the researchers reported.

Furthermore, the University of Florida researchers conclude that within 6 years, 33% of implants required at least one additional surgery. A Mayo Clinic research team reported, in the March 1997 New England Journal of Medicine that one of every four women face additional surgery within the first five years of receiving implants. The Mayo researchers also found high numbers of breast deformities, hematomas and bleeding, contractures, chronic pain and necrosis of the nipple.

Implant rupture allows silicone to spread throughout a woman's body. A Harvard research team has studied the migration of silicone inside the body and tracked it to the liver and other vital organs. A Baylor College of Medicine research team has found that silicone from implants can cause fatal liver and lung damage in mice. However, the long-term effect of silicone once it reaches these organs in women has not been adequately addressed.

The exact mechanism by which silicone can cause serious harm is still a matter of scientific inquiry. But numerous studies have linked silicone to an immune system breakdown. In fact, this year's Office of Science and Technology (a division of the FDA's Center for Devices and Radiological Health) Annual Report describes their research showing significant immunological responses to silicone breast implants in both humans and animal models.

The first large-scale governmental investigation into long-term disease outcomes in implanted women is expected to be made public next year. The National Cancer Institute's chief environmental epidemiologist, Dr. Louise Brinton, who is heading an in-depth study of 13,000 implanted women, has said the possibility of a silicone-related disease is "not a closed book."

New legislation currently pending in Congress calls for further government-sponsored research into the long-term hazards of silicone and for adequate informed consent protocols. "We have recognized that these problems exist and are pushing for accurate and thorough informed consent and more research about the unknown risks of silicone breast implants," said Rep. Gene Green (D-TX), a sponsor of the bill.

For more information or copies of any of the studies please contact Karin Wallestad, ph 202-822-5200 x 229.

CO: Command Trust Network, Inc.; Institute of Medicine

ST: District of Columbia

IN: HEA MTC

SU:

06/21/99 10:46 EDT