Fw: Over 193,000 Adverse Events reported to FDA

[Guest guest]

Can't remember if I already sent this, so I thought I would again just in

case.

Patty

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

From: Ilena Rose <ilena@...>

<Recipient List Suppressed:;>

Sent: Friday, September 08, 2000 3:49 PM

Subject: Over 193,000 Adverse Events reported to FDA

> (from page 52/3 from their booklet

> http://www.fda.gov/cdrh/breastimplants/indexbip.html)

>

> How many reports of adverse events or product problems has FDA received?

> From 1985 until January 2000, FDA received 127,770 adverse reaction

reports for

> silicone gel-filled breast implants. During the same time period, FDA

> received 65,720

> adverse reaction reports for saline-filled implants. (There may be some

> duplicate

> reports.) The greater number of reports for silicone gel-filled implants

> does not

> necessarily mean that there are more problems with this type of implant

> but may reflect

> that more women received silicone gel-filled implants than saline-filled

> implants. There

> were 1712 additional summary reported problems in which the type of

implant was

> unknown.

>

> As of January 2000, FDA received 123 reports of deaths reportedly related

> to breast

> implants. The reports are not confirmed by autopsy, and they do not show

> that breast

> implants necessarily caused the deaths. In fact, in some cases, the actual

> cause of death

> was not specified. A few of the reports related the cause of death to the

> surgical

> procedure for implants. This included problems with anesthesia during

> surgery, deaths

> from surgical complications such as hemorrhage (heavy blood loss), or

> infection. The

> reports did not show that the implants themselves caused the reported

deaths.

> There were a few reports of women dying of the complications of diseases

> such as cancer

> or CTDs (e.g., rheumatoid arthritis). However, because these illnesses

> occur in people

> with and without the implants, there is no evidence that the implant

> actually caused the

> illnesses or the deaths. According to the scientific studies done so far,

> women do not

> have a significantly greater risk of illness, including scleroderma,

> rheumatoid arthritis

> and cancer, or death if they have breast implants (refer to the Other

> Illnesses section).

>

>