WEBMD: FDA Reviews Ban on Silicone Breast Implants #1

[Guest guest]

From: Ilena Rose <ilena03@...> wrote:Date:

Mon, 11

Apr 2005 17:45:36 -0600

From: Ilena Rose <ilena03@...>

Subject: WEBMD: FDA Reviews Ban on Silicone Breast

Implants #1

http://my.webmd.com/content/Article/104/107388.htm?printing=true

> EXCERPT:

>

> Ilena Rosenthal, director of the Humantics

> Foundation, a group opposed to breast implants, says

> that " thousands " of women in her organization have

> serious health problems that they attribute to their

> breast implants and to silicone. The group is urging

> the FDA to keep silicone implants off the market for

> most women.

>

> " These are not recallable items, at least without

> more surgery to get them out. It's not like taking

> Vioxx or Bextra off the shelves, " Rosenthal says in

> an interview, referring to the two painkillers

> recently pulled from the market due to an elevated

> risk of heart attacks and strokes.

>

> Original page:

> file:///C:/content/Article/104/107388.htm

>

> ---------------------------------

>

> FDA Reviews Ban on Silicone Breast Implants

>

> 2 Companies Want Silicone Gel-Filled Implants Back

> on U.S. Market

>

> By Todd Zwillich

> WebMD Medical News Reviewed By Brunilda Nazario, MD

> on Monday, April 11, 2005

>

> April 11, 2005 - The FDA is beginning a review that

> could see controversial silicone breast implants

> return to the U.S. market. Today an FDA panel heard

> oral presentations from the public.

>

> The implants were banned 13 years ago except for a

> limited number of women participating in clinical

> trials. Now, two makers of the implants - Inamed and

> Mentor -- are trying to show the FDA that the

> implants have been redesigned and carry minimal

> health risks for women. The companies will speak

> before the panel on Tuesday.

>

> But ahead of the three-day hearing, agency reviewers

> questioned whether the companies have enough data to

> show that the silicone gel-filled implants are safe

> in the long term.

>

> An FDA advisory panel voted 9 to 6 in 2003 to

> recommend that Inamed be allowed to sell its

> silicone gel implants to U.S. women. An earlier

> version of the implants was banned in 1992 amid

> fears that they were prone to rupture and leakage

> that may lead to health problems.

>

> But the agency went against its advisers and

> rejected the application, citing concerns that the

> company had shown that the implants can remain

> durable for more than a couple of years.

>

> Concerns About Ruptures

>

> Inamed's implants rupture in up to 21% of patients

> within three to four years, depending on the type of

> surgery used to place them, according to data

> submitted by the company in advance of this week's

> review. The implants ruptured in 3.4% of women who

> used them for cosmetic breast augmentation, the most

> common reason for surgery.

>

> Mentor reported that its implants rupture in up to

> 5% of women within two to three years of surgery and

> in 0.5% of women who have breast augmentation.

>

> Ruptures can lead to pain and hardness in the

> breasts and can also damage the appearance of the

> implants, according to European and American

> studies.

>

>

> Claims of Illnesses

>

>

> Silicone gel-filled implants have also been plagued

> by concerns that they can cause serious systemic

> health problems like lupus or even cancers. A

> federal judge in 1999 approved a $3.2 billion legal

> settlement between one-time manufacturer Dow Corning

> and thousands of women who claimed to have suffered

> adverse health consequences from their implants.

>

> In 1999, a report from the Institute of Medicine

> stated that women with silicone breast implants are

> no more likely to develop life-threatening

> illnesses, but it's clear that they can cause

> serious problems.

>

> Ilena Rosenthal, director of the Humantics

> Foundation, a group opposed to breast implants, says

> that " thousands " of women in her organization have

> serious health problems that they attribute to their

> breast implants and to silicone. The group is urging

> the FDA to keep silicone implants off the market for

> most women.

>

> " These are not recallable items, at least without

> more surgery to get them out. It's not like taking

> Vioxx or Bextra off the shelves, " Rosenthal says in

> an interview, referring to the two painkillers

> recently pulled from the market due to an elevated

> risk of heart attacks and strokes.

>

> A 2003 Danish study of 238 women showed that those

> with ruptured implants -- in which liquid leaked

> beyond tissue immediately around the implant -- were

> three times as likely to report connective tissue

> disease such as rheumatoid arthritis and

> fibromyalgia. They were also twice as likely to

> complain of fatigue as women whose implants remained

> intact.

>

> Other studies have suggested that the silicone

> gel-filled implants can interfere with mammography

> screenings, making it more likely that breast cancer

> goes undiagnosed.

>

> FDA scientists cautioned that the study did not look

> at women using Mentor or Inamed implants.

>

> Both companies say they plan to set up detailed

> patient registries to follow the health of patients

> in the years after their surgeries.

>

> FDA reviewers expressed concern that the data

> submitted by the companies looked only at a

> relatively small number of women and could not

> closely estimate all of the potential health effects

> of ruptures.

>

> They also said it remains impossible to tell how

> many of the implants could rupture 10 or more years

> following surgery. Some theoretical estimates put

> the number between 21% and 74%.

>

> " It is difficult to reasonably predict the

> probability of rupture through year 10, " FDA

> officers wrote in their review.

>

> The committee is expected to cast votes on the two

> companies' products Wednesday.

>

> ---------------------------------

>

> SOURCES: FDA Summary panel memorandum P030053,

> Mentor PMA application. FDA Summary panel memorandum

> P020056, Inamed PMA application. Ilena Rosenthal,

> director, Humantics Foundation.