Woke up to bad news! WASH POST: Surgeon Changes Tune on Breast Implants

[Guest guest]

From Ilena:

>

>

http://www.washingtonpost.com/wp-dyn/content/article/2005/05/10/AR2005051001231_\

pf.html

>

> washingtonpost.com

> Surgeon Changes Tune on Breast Implants

>

> By Marc Kaufman

> Washington Post Staff Writer

> Wednesday, May 11, 2005; A08

>

>

>

> Whalen, the surgeon often credited with

> persuading the Food and Drug Administration in 2003

> to reject wider use of silicone gel breast implants,

> has changed his mind.

>

> Whalen, now a private citizen, wrote to acting

> Commissioner Lester M. Crawford last month that the

> implant makers have made their case that the devices

> are safe and that the FDA should approve the

> applications of two companies that want to sell them

> for general use.

>

> In 2003, as chairman of an expert panel advising the

> FDA on the issue, Whalen criticized the group's

> majority vote in favor of the implants and persuaded

> the agency to turn down the application, arguing

> that the company had not proved their safety.

>

> He was not a member of a separate expert panel that

> reheard the issue last month and unexpectedly

> recommended approval of one company's silicone

> implants while rejecting a competitor's. The FDA has

> said it will make a decision in the near future.

>

> " Much of my change in philosophy over this difficult

> issue arises from a newfound perspective that to not

> allow these devices for women who knowingly make the

> choice to have them is sexist, " Whalen wrote. " I

> feel that the time has arrived and the data is

> sufficient to approve these devices. "

>

> Because Whalen's criticisms of the silicone gel

> application after the 2003 meeting were widely seen

> as an important factor in the FDA's subsequent

> rejection, the turnaround was hailed yesterday by

> some implant makers.

>

> " We certainly believe that we provided FDA the

> information it needs to support our approval, " said

> Dan Cohen, vice president for global government

> affairs for Inamed Corp., whose implants were

> reviewed in 2003 and last month. " We're pleased to

> hear that Dr. Whalen, who chaired the 2003 panel,

> also believes the [application] is approvable. "

>

> But Zuckerman, president of the National

> Research Center for Women & Families, said the

> letter should be disregarded because Whalen had not

> attended the most recent hearing and had not seen a

> transcript of the proceeding before writing his

> letter. As a result, she said, he was not aware of

> what she considered the dangerous shortcomings of

> the safety data presented.

>

> " He was greatly criticized for his position last

> time by the plastic surgeons, who are his fellow

> surgeons, and it seems that they may have pressured

> him to write a letter showing his confidence in them

> and this product that they want approved, " she said.

> " But unfortunately he didn't have the information he

> needed to make a well-informed recommendation. "

>

> Currently, silicone implants are available only to

> women needing reconstructive surgery or who agree to

> take part in a clinical trial; all others must use

> implants filled with saline solution, which many say

> look and feel less natural.

>

> Whalen, a pediatric surgeon at the University of

> Medicine and Dentistry of New Jersey at the

> Wood Medical School in New Brunswick,

> declined to discuss his letter to Crawford, a copy

> of which was obtained by The Washington Post.

>

> The most recent expert advisory panel voted in favor

> of an application by Mentor Corp. but against a

> competing bid by Inamed.

>

> ~~~~~~~~~~

>

> www.BreastImplantAwareness.org

>

>

> ~

>

>