Silicone Implant Saga Illustrates Vital Importance of the Civil Justice System

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Alliance for Justice Releases Important New Study; Silicone Implant

Saga Illustrates Vital Importance of the Civil Justice System

6/21/2006 11:03:00 AM

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National Desk, Health Reporter

Contact: Landis of the Alliance for Justice, 202-464-7350

WASHINGTON, June 21 /U.S. Newswire/ -- Alliance for Justice today

released " Independent Justice: How Our Civil Justice System Protects

Consumers and Patients in Ways the Regulatory System Does Not. " Using

the civil justice system, women injured by silicone breast implants

confronted medical manufacturers. Plaintiffs peeled away layers of

secrecy, obfuscation and outright dishonesty to reveal the real

danger

of leaking silicone implants to the unaware public.

" The implant story illustrates the danger of relying on manufacturers

and government regulators to guarantee the safety of consumer

products

when the government is reliant on research submitted by the very

companies it is supposed to be regulating, " said Nan Aron, president

of the Alliance for Justice. " It was only through litigation that the

danger caused by implants was exposed, " Aron continued.

Responding to the report, the Senior House Democrat on the FDA's

funding subcommittee, L. DeLauro (D-Conn.) said, " There is a

growing list of FDA approved drugs and medical devices -- products

like Vioxx, Fen-Phen, silicone implants and defibrillators -- that

have subsequently proved to be dangerous. The FDA must increase its

oversight of approved products so that women will not have to fend

for

themselves when their health is at risk. "

The report examines the history beginning in the 1960's when implants

came on the market without any government approval, and continues

through the onset of problems and the first successful lawsuit

against

a manufacturer in 1977. During the course of the litigation, company

documents emerged that revealed strong internal concerns about the

implants and established a startling lack of research into implant

safety. As the courts steadily uncovered information about implants,

the FDA took halting steps before finally forcing manufacturers to do

research that demonstrated their products' safety. In the end, the

manufacturers failed to do so, and the agency pulled implants from

the

general market in 1992. Only through the civil justice system was the

general public made aware of the dangers that these implants could

potentially pose to women's health.

Despite subsequent research that has confirmed that nearly all

silicone implants eventually rupture, the FDA today appears poised to

allow silicone-gel implants back on the market for cosmetic purposes.

" Our civil justice system has proven invaluable in the past to ensure

that American patients have ultimate control of their health and

well-being, and it is crucial that Americans can continue to stand up

for their rights, " concluded Aron.

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The full report is available at

http://www.allianceforjustice.org/independentjustice.pdf.

For more information, or to speak with Alliance for Justice President

Nan Aron, contact Landis at 202-464-7350.

http://www.usnewswire.com/

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www.BreastImplantAwareness.org