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Settlement Awards $11.3 Million to U.S. Gov't for Silicone Breast Implant Medicaid Expenses

BIRMINGHAM, Ala.--Sept. 22, 2004--

Resolving a massive lawsuit filed four years ago by the U.S. government, major breast implant manufacturers Bristol-Myers Squibb, Baxter Healthcare Co., 3M, Union Carbide and other parties have agreed to pay $11.3 million to reimburse expenses paid out to women injured by silicone gel breast implants. In September 2002, the government settled for nearly $10 million with the Dow Corning Corporation as part of its bankruptcy proceedings.

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.(1) Manufacturers Inamed and Mentor currently have applications pending. In January, the U.S. Food and Drug Administration refused to make the devices more broadly available, citing safety concerns. The agency asked manufacturer Inamed to submit more data to explain high rupture rates and other problems associated with the device. Currently companies are allowed to sell the breast implants 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, a support group for women with silicone gel breast implants. Goldrich's activism led to initial restrictions on the sale of the devices in the early 1990s.

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 past criminal investigations of Mentor, one of the manufacturers conducting the trials.(2)

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).

"This is a classic case of the government's left hand not knowing what the right hand is doing. At the same time the DOJ is suing breast implant manufacturers due to their safety concerns, the FDA is considering loosening restrictions on their sale," said Goldrich.

"I am glad that the DOJ realizes the safety risks of breast implants. I hope that FDA will follow their lead and make sure that women's health is not further threatened by these devices."

(1) "Panel Chair Opposes Advice on Breast Implants," Washington Post. 
    6 November 2003.
(2) "FDA ends inquiry on maker of implants," Dallas Morning News. 
    1 October 2002.

     Contacts:
     Command Trust Network

Dane VandenBerg, 202-466-9633

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