Associated Press

By LIBBY QUAID

WASHINGTON (AP)

Kim Hoffman was wearing a hospital gown, aboutto have breast implant surgery, when a consent form was thrust into her hands. Hoffman didn't know that the Food and Drug Administration had banned her silicone-gel implants, except for a few women receiving them in strictly controlled clinical trials, she said. She was told the consent form was just more red tape, Hoffman said.

``I didn't understand that I was part of an experiment,'' the Marshfield, Mo., woman said during a Capitol news conference Thursday.

Eight months later, she had the implants removed after suffering a range of complications, including debilitating muscle weakness and tremors that cost Hoffman her job running two preschools. Her story and others like it have prompted legislation that would require stricter FDA regulations, more extensive government-funded research and more information about potential health risks from implants.

The measure is especially timely because of new research suggesting that, counter to earlier studies, women with breast implants may face higher risks of lung and brain cancers as well as the painful condition fibromyalgia, said Diana Zuckerman, director of the National Center for Policy Research for Women and Families. She said research to date is lacking, especially on patients who received implants for reconstruction after undergoing mastectomies.

``Do implants create health risks, and do women with implants die at a younger age?'' Zuckerman asked. ``Those are still questions we need to answer.'' She mentioned a study by researchers from FDA and the National Institutes of Health linking ruptured silicone gel breast implants to fibromyalgia. However, another study to which she referred has also been interpreted as generally reassuring.

National Cancer Institute researchers said a study they released in April found that while women with implants do face slightly increased risks of developing lung and brain of cancers, they do not face such risks for most cancers, including cancers of the mouth, stomach, large intestine, breast, cervix, uterus, ovary, bladder, thyroid, connective tissues and immune system.

Rep. Roy Blunt, R-Mo., said he and other sponsors of the legislation want sound science and thorough FDA oversight, ``so women who have suffered the trauma of a mastectomy won't become a victim again because of reconstructive surgery.'' Blunt became involved in the issue because Hoffman is a constituent.

Women have a right to know whether their symptoms were triggered by implants, said Rep. Gene Green, D-Texas. ``The government should support research that will independently and comprehensively answer questions surrounding these products,'' said Green, a sponsor who has pushed a similar measure for the past few years.

Introduced Thursday, the measure would require the National Institutes of Health to intensify research into potential health problems caused by breast implants, along with expanding FDA's efforts to distribute accurate and current implant data.

Lawmakers also seek to force the FDA to complete its ongoing criminal investigation of an implant manufacturer accused of data manipulation in its trials of breast implants. In addition, the FDA would perform tougher evaluations on saline implants already on the market under the bill. Between 1.5 and 2 million women have received breast implants since 1962, about 80 percent for cosmetic reasons and the rest as breast reconstruction after cancer.