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

Sent: Tuesday, March 20, 2001 9:10 AM

Subject: Europe Considers Safety Guidelines for Breast Implants

> ~~~ Thanks so much to those in our International Support Group in Europe

> who have been working tirelessly on this for so long ... some right this

> moment! BRAVO! ~~~

>

> EU Considers Safety Guidelines for Breast Implants

>

> Brussels, March 20 (Bloomberg) -- The European Commission will propose

> Wednesday new guidelines for breast implants that may require patients to

be

> warned of possible safety problems, place tighter regulations on plastic

> surgeons and fund research.

>

> The commission's action comes in response to a petition sponsored by Bill

> , a ish Labour Member of the European Parliament.

>

> Some breast implant patients allege that they developed health problems

such as

> arthritis and lupus after surgery. Lawsuits forced Dow Corning Corp. to

file

> for bankruptcy protection in 1995. The company denied a link between its

> products and disease.

>

> ``Europe has recognized that there is a problem with silicone implants and

is

> going to do something about it,'' said in a statement. ``The health

of

> thousands of British women is put at risk by an implant industry which

seems to

> have avoided basic standards of information and safety regulation.''

>

> 's petition calls for counseling for patients before and after

surgery by

> someone other than the doctor, a register of surgeons qualified to do

implants

> and national registers of implants done in the 15 EU countries. He also

hopes

> to raise the age limit for surgery to 18 years old.

>

> Ensuring Quality

>

> ``Our role is to ensure the quality and safety levels of the products and

> procedures are maintained at the highest level and constantly improved,''

said

> Per Haugaard, a spokesman for European Enterprise Commissioner Erkki

Liikanen

> who will make the announcement Wednesday.

>

> ``But there are inherent risks in some operations that patients should be

made

> aware of,'' Haugaard said. ``The problems in the past should be avoided in

the

> future if they are properly informed.''

>

> While the Commission can't regulate the age that patients undergo the

> treatment, it can recommend patients under 18 not be allowed cosmetic

surgery,

> said.

>

> ``I'll get them all passed, but in some cases, like age, they'd be

voluntary,

> and others, such as the counseling and research funding, will be

mandatory,''

> said.

>

> A select committee of the U.K. Parliament will meet Thursday to discuss

the

> information given to patients before and after breast implant surgery,

> according to Helen Kearns, a spokeswoman for .

>

> In 1998, a U.K. health panel concluded silicone breast implants weren't

linked

> to connective-tissue disease or abnormal immune reactions.

>

> Mentor Corp. of the U.S. last year won U.S. Food and Drug Administration

> approval for its saline-filled breast implants. In the U.S., the devices

can be

> used for breast reconstruction after cancer and cosmetic augmentation in

women

> over age 18.

>

> At the time of the decision, FDA officials warned that women should be

aware of

> implants' high rate of complications and failure.

>

> Mar/20/2001 8:51 ET

>

>

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