Fw: Saline Breast Implants Still Popular But Women Not ProperlyInformed of Risks.

[Guest guest]

From: Ilena Rose <ilena@...>

Sent: Friday, February 23, 2001 7:22 PM

Subject: Saline Breast Implants Still Popular But Women Not ProperlyInformed

of Risks.

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> This story was printed from FindArticles.com, located at

> http://www.findarticles.com.

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> HealthFacts

> May, 2000>

>

> Saline Breast Implants Still Popular But Women Not Properly Informed of

Risks.

> Author/s: ann Napoli

>

> After a high-profile court case and subsequent Congressional hearings

> revealed that the safety of silicone-gel breast implants had never been

> proven, they were banned in 1992, except for women enrolled in clinical

> trials. The Food and Drug Administration (FDA) permitted the continued use

> of saline-filled implants, though their safety had never been established

> either. Both types were already on the market well before the FDA obtained

> authority to regulate medical devices in 1976 in the wake of bad publicity

> surrounding the Dalkon Shield, the intrauterine device which caused death

> and complications in thousands of women.

>

> Saline implants were allowed to remain on the market not because they were

> any less likely to rupture than silicone implants but because leakage of

> salt water throughout the body was thought to present less of a hazard

> than leaking silicone. Bad press and the virtual unavailability of

> silicone implants caused a major decline in implant surgery. But now

> implant surgery has become more popular than ever. About 103,000 women got

> saline implants last year; most of them for breast enlargement. A minority

> were women with breast cancer who have implants as part of reconstruction

> after a mastectomy.

>

> In March, an FDA-appointed advisory panel of experts met to determine the

> safety of several brands of saline implants. The panel recommended that

> the FDA give conditional approval to two companies that make saline

> implants, Mentor and McGhan. Approval was based on unpublished data

> submitted by each company in compliance with the FDA requirement to follow

> at least 1,000 implant recipients for at least two years.

>

> Zuckerman, executive director of the National Center for Policy

> Research for Women and Families, Washington, DC, who spoke on behalf of

> the consumer at the FDA advisory panel meeting, expressed serious concerns

> about " the adequacy of the studies that had been conducted and the high

> complication rates that the manufacturers reported.' Ms. Zuckerman, who

> has a long history of advocacy on this issue, said in a telephone

> interview that the FDA has not as yet decided to act on the advisory

> panel's recommendation for approval. Furthermore, approval might be

> withheld from Mentor, she explained, because the company is under criminal

> investigation for research irregularities.

>

> During the public comment session of the FDA meeting, women reported that

> they had not been informed by their physicians about the risks of implant

> surgery, a complaint that was heard many times when silicone implants were

> in the news. Long-term health risks are hard to quantify since most

> studies lasted only 7-12 years, and most symptoms show up after that,

> observed Ms. Zuckerman. Virtually all but a small minority of these study

> participants had silicone not saline implants.

>

> According to an FDA panel member, theres a " fairly high chance that a

> woman with saline implants will need additional surgery at some point. "

> Mentor reported follow-up results of 1,680 recipients of its saline

> implants: 27% of them had theirs removed within three years of

> implantation because of capsular contracture, infection, or pain. In about

> 9% of cases, the implants rupture within three years leading to repeat

> surgery. This risk was three times greater for women with breast cancer

> than for women who had implant surgery for breast enlargement.

>

> About 40% of women with breast cancer who had saline implants required

> repeat surgery within three years and 24% experienced capsular

> contracture, the most common complication. A hard web of scar tissue can

> form around any device that is implanted in the body and can only be

> treated with surgery or removal of the implants. Those who decide to give

> up and have the implants removed will inevitably have a bad cosmetic

> result. " Women have to understand that this is an irrevocable decision,

> you can't go back to what you looked like before. The tissue is stretched,

> and the breasts will never look the same, " said Ms. Zuckerman, referring

> to women who had implants for breast augmentation.

>

> Suggestions

>

> -Before deciding to undergo implant surgery, visit the Web site of Ms.

> Zuckermans organization (www.cpr4womenandfamilies.org). You will find an

> extensive critique of the studies that supposedly prove the short-term

> safety of saline implants, plus a critique of the FDA's process for

> approving medical devices.

>

> -For you own records, get as much information as possible about the

> implants, such as the manufacturer and serial number.

>

>