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Lawsuit Claims That Penile Implants Are Ineffective, Dangerous

May 21, 1994

SAN FRANCISCO (AP) _ Silicone penile implants, widely used as a remedy for male impotence, are ineffective and dangerous, three couples claimed in a lawsuit filed Friday.

Two of the men who filed the lawsuit said they suffer severe pain. The third man said he suffers loss of feeling and has undergone reconstructive surgery.

Their wives said defects in the implants interfered with their sexual relations and marital companionship.

The lawsuit was filed against Minnesota-based American Medical Systems Inc., the largest U.S. manufacturer of silicone penile implants, and its parent company, Pfizer Inc.

Ken Markowitz, a lawyer for American Medical Systems, did not return telephone messages.

The lawsuit, filed by three Sacramento-area couples, seeks damages for medical costs, pain, punitive damages, and funding for a program of medical monitoring and research.

The lawsuit claims the implants can cause infection, disfigurement, and immune-system disorders caused by silicone leakage. Women who have silicone breast implants have made the same claims.

The penile implant lawsuit seeks to represent all buyers of American Medical Systems penile implants since they were first marketed in 1973, said Dan Bolton, a lawyer for one of the plaintiffs. Several men already have won verdicts against penile implant manufacturers, he said.

Penile implants are inserted surgically in men who have become impotent, and are inflated by a pump. About 300,000 men in the United States have them, Bolton said.

The U.S. Food and Drug Administration does not prohibit the implants, but plans to review their safety while considering applications from manufacturers to allow their continued sale, he said.

Bolton has also represented women in breast implant lawsuits, which have led to new FDA restrictions on those products and a proposed $4.7 billion settlement from major manufacturers.

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