| BreastImplantAwareness.org 2006-06-21, 4:27 pm |
| 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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To: National Desk, Health Reporter
Contact: Kelly 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, Rosa 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/i...entjustice.pdf.
For more information, or to speak with Alliance for Justice President
Nan Aron, contact Kelly Landis at 202-464-7350.
http://www.usnewswire.com/
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www.BreastImplantAwareness.org
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