Fw: Lawmakers Concerned About Breast Implants Seek More Research, Oversight ~ AP

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Friday, May 25, 2001 11:40 AM

Subject: Lawmakers Concerned About Breast Implants Seek More Research,

Oversight ~ AP

> ~~~ Thank you Kim! ~~~

>

> Lawmakers Concerned About Breast Implants Seek More Research, Oversight

> By LIBBY QUAID>

>

> WASHINGTON (AP)

>

>

>

> Kim Hoffman was wearing a hospital gown, about to 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 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.

>

>

>