Groups urge US to reject silicone breast implants & Toxic Request

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Note: forwarded message attached.

Click here: US News Article | Reuters.com

http://www.reuters.com/newsArticle.jhtml?type=domesticNews & storyID=8590305

Groups urge US to reject silicone breast implants

Tue May 24, 2005 11:58 AM ET

WASHINGTON (Reuters) - U.S. regulators should deny applications to sell silicone gel-filled breast implants because the manufacturers have not met the legal benchmark for proving safety, 20 consumer groups and individuals said in a petition released on Tuesday. Inamed Corp. and Mentor Corp. are trying to win Food and Drug Administration approval to resume widespread sales of silicone breast implants for the first time since 1992.

The petitioners said neither company has met the requirement in federal law that makers provide a "reasonable assurance" that the implants are safe. "Even if interpreted in the manner most favorable to Inamed and Mentor, the data regarding safety are inconclusive, and FDA therefore must deny both applications," said the petition, signed by Public Citizen, the National Organization for Women and others.

In April, an FDA advisory committee voted 5-4 against Inamed's implants, while urging approval for Mentor's implants by a 7-2 vote. The FDA is considering those recommendations and is expected to make a final decision around mid-July. Many women believe leaking silicone from ruptured implants has made them sick with debilitating illnesses, but studies have failed to find a connection between the devices and chronic disease.

The implants can, however, cause painful scarring and other complications in the breast area. FDA spokeswoman Kathleen Quinn said the agency will carefully review the petition. Spokespeople for Mentor and Inamed could not immediately be reached for comment.

Both companies previously have defended their silicone implants as safe and more natural-looking than saline-filled breast implants, the only option for most U.S. women. Silicone implants are allowed through clinical trials for breast cancer patients and other women who need reconstruction surgery.

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http://www.washingtonpost.com/wp-adv/advertisers/popunders/lowerbills_jan05_wp.html

Groups Petition to Block Silicone Implants

The Associated Press

Tuesday, May 24, 2005; 8:27 PMWASHINGTON -- Federal law requires that makers of silicone-gel breast implants settle questions about how long they last before the devices are allowed back onto the market, critics argued Tuesday in a petition to the government.

That's contrary to a recent recommendation from the Food and Drug Administration's scientific advisers, who in April said manufacturer Mentor Corp. should be allowed to sell the controversial implants if, among other things, it conducted post-marketing studies to settle lingering concerns about durability and safety.

"The law does not allow for an 'approve first, test later' approach," wrote attorney Schultz, a former FDA official who co-authored the petition for the National Women's Health Network and 16 other consumer advocacy groups that oppose the implants' return.

The FDA will consider the petition, a spokeswoman said.

Silicone-gel implants have been virtually banned for 13 years, available only to certain women through research studies, restrictions imposed because of fears that leaking silicone was dangerous. Today, implants have largely been exonerated of causing serious or chronic illnesses such as cancer or lupus. But they can break apart, as well as cause infection and painful, rocklike scar tissue.

Mentor and rival Inamed Corp. want to resume sales, arguing that their studies show only a small percentage break over three or four years _ and that women want an alternative to the salt water-filled breast implants that are today's main option.

FDA scientists have called the companies' research too limited to settle durability questions.

But the agency's scientific advisers last month issued a split decision, backing Mentor's brand but rejecting Inamed's pending more data. The FDA isn't bound by its advisers' decisions, but typically follows them.

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Subj: Toxic Request

Date: 5/24/2005 6:40:30 PM Eastern Standard Time

From: toxicdiscovery@...

Looking for Doctors in NC to review women for the RSP or Dow Claims. Please submit doctor and address.

Thanking you in advance,

Kathy L. ley ston, R.N.

Executive Director

Toxic Discovery

601 W. Nifong - Bldg. 3B.

Columbia, MO. 65203

Phone: (573) 817-2090 - NEW

Fax: (573) 445-4700

kkjohnston@...

www.toxicdiscovery.com