Fw: Implants were not evaluated for safety by the FDA

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Tuesday, September 24, 2002 6:56 AM

Subject: Implants were not evaluated for safety by the FDA

> Implants were not evaluated for safety by the FDA

>

> Before the disclosures of industry and the media forced the issue to a

> head,

> patients assumed that silicone-gel implants had long ago been deemed

> safe.

> Interviews with University of Southern Florida (USF) patients and others

>

> indicate that few plastic surgeons reviewed possible systemic risks in

> any

> significant detail and that, unless specifically requested, they had not

>

> provided patients with the package inserts that came with the implants.

> As

> of January 1982, however, silicone implants had been only

> " preliminarily "

> (not officially) placed in Class III by the FDA--which meant the devices

>

> would be evaluated and regulated to assure safety and

> effectiveness--given

> that the FDA believed the devices posed " a potentially unreasonable risk

> of

> injury. " Still, safety data from manufacturers--due to the 1976

> grandfather

> statute--did not require research findings to be submitted for FDA

> review.

> Implants slipped through an unusual loophole.

>

> After the publication of the Japanese findings in English-language

> journals

> in the late 1970s, only a limited number of other reports of

> silicone-related illnesses appeared in the medical literature, including

> one

> paper by B.F. Uretsky et al. In 1979 in the " ls of Plastic

> Surgery. "

> This article described a woman who nearly died of kidney failure before

> her

> implants were removed. But the publication of these reports failed to

> spur

> significant action. Around the same time, other papers were published,

> also

> apparently without much attention, in such publications as The Journal

> of

> Aesthetic Plastic Surgery, The American Journal of Clinical Pathology,

> The

> British Journal of Plastic Surgery, Plastic and Reconstructive Surgery,

> The

> Journal of the American Medical Association, Arthritis & Rheumatism, and

> The

> Archives of Pathology and Laboratory Medicine.

>

> Then in January 1984 an article appeared in Arthritis & Rheumatism,

> written

> by two well-respected rheumatologists in Pittsburgh, Tom Medsger and

> Gerald

> Rodman. It described 18 patients who had signs of rheumatic disease and

>

> silicone implants. It was this report that focused the attention of the

>

> University of South Florida Division of Rheumatology on the issue.

>

> Between 1984 and 1988, rheumatologists at the USF began to see many more

>

> implant recipients with signs and symptoms of rheumatic illness; yet

> only

> and occasional paper on the subject was published in the medical

> literature.

> It is generally believed that many surgeons and physicians who did look

> into

> the correlation of rheumatic illness and silicone implants found it to

> be

> inconsequential. Nobody thought silicone implants could cause rheumatic

>

> diseases, nor were they viewed as a potential public health problem. As

> a

> result, not until June 1988--26 years after the first implant--did the

> FDA

> issue a final regulation to classify breast implants as potentially

> dangerous, confirming them as a Class III device, thus " requiring " more

> stringent regulation. It was not until early 1992 that the FDA finally

> called for a complete moratorium on and an investigation into

> silicone-gel

> implants.

>

> -------

>

> >From the book, " The Silicone Breast Implant Controversy " by: B.

> Vasey,

> M.D. & Josh Feldstein (pages 18 and 19).

>

> MJ

>