Fw: Government Seeks Reimbursement Even as Manufacturers Ask to Put Implants Back on Market

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Tuesday, September 24, 2002 3:13 AM

Subject: Government Seeks Reimbursement Even as Manufacturers Ask to Put

Implants Back on Market

> Settlement Awards Nearly Ten Million Dollars to U.S. Government for

> Silicone Breast Implant Expenses

>

> Government Seeks Reimbursement Even as Manufacturers Ask to Put Implants

> Back on Market

>

> DETROIT, Sept. 20 /PRNewswire/ -- Yesterday evening the judge

> overseeing the Dow Corning bankruptcy signed an order authorizing a $9.8

> million settlement with the U.S. Government for medical expenses from

> breast implant related injuries. The settlement resolves the

> government's claim to reimburse federal agencies for payments related

> to the devices. Ironically, the government is being paid millions of

> dollars even though silicone breast implants are still commercially

> available and manufacturers are requesting that the U.S. Food and Drug

> Administration put the devices back on the market without restriction.

> Manufacturers Inamed, Mentor and Silimed have announced their plans to

> file the U.S. Food and Drug Administration's Pre-Market Approval

> applications for unrestricted sale of silicone implants by the end of

> 2002. Currently all three companies are allowed to sell the devices

> for cosmetic purposes as part of clinical studies. " Injuries from

> silicone breast implants have cost the U.S. Government millions in

> medical expenses; it is inconceivable that the FDA would consider

> lifting any restrictions on their sale, " said Sybil Niden Goldrich,

> Founder and Executive Director of the Command Trust Network and implant

> survivors' representative on the Tort Claimants' Committee. Due to a

> regulatory loophole, the FDA has never approved silicone breast

> implants, nor have they ever been proven safe. However, as many as two

> million women had received the devices by 1992 when the FDA declared a

> partial moratorium on their sale due to health complaints. Until the

> first augmentation-only clinical trial was approved by the FDA in 1998,

> implants were only available to breast cancer survivors and women

> replacing the devices, provided they participated in a

> manufacturer-sponsored study. However, members of the U.S. Congress have

> raised concerns about the data and poor follow-up of these trials and

> have pointed to on-going criminal investigations of Mentor, one of the

> manufacturers conducting the trials. The U.S. government sought

> reimbursement on behalf of the U.S. Department of Defense, Veteran

> Affairs, Health and Human Services, the Indian Health Service and the

> Centers for Medicare and Medicaid Services (formerly the Health Care

> Financing Administration). Although Dow Corning's plan to compensate

> women injured by silicone breast implants was approved nearly three

> years ago, no checks have been sent to claimants to date. The U.S.

> Government claim was one of the last legal roadblocks to implementing

> the plan. Other appeals are pending. The agreement prevents the

> government from seeking any additional compensation for implant claims

> from Dow Corning or from claimants who had Dow Corning breast implants

> except in instances of criminal or fraudulent activity. However, the

> government is free to pursue compensation from other manufacturers.

> The U.S. is in litigation against former implant makers 3M, Bristol

> Myers Squibb and Baxter Healthcare Corporation. gove

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