A Los Angeles Superior Court jury awarded a Chatsworth bank executive $300,000 in damages Monday from the manufacturer of a penile inflation device that failed, causing him permanent sexual problems, the man’s lawyer said.
William Neuser, 49, won the judgment in Van Nuys Superior Court against American Medical Systems, a Minnesota firm that is the largest U. S. maker of penile implants. Neuser sued the firm in 1989 after a tube in his implant fell out, rendering it useless, said Robert M. Ross, Neuser’s attorney.
Ross said the jury award was the largest in California against a maker of penile implants, which are at the center of a national debate over safety and effectiveness. About 350,000 American men have the devices, and about 28,000 more get them each year.
The U. S. Food and Drug Administration announced this year that makers of inflatable implants--the most popular type--would be required to submit scientific evidence that their products are safe and effective.
The agency also intends to require implant patients to sign informational letters outlining the risks involved, including possible immune-system problems that may be linked to silicone used in the implants.
Recent studies show that over time, implants fail and may require additional surgery in about one-third of all recipients.
Ross said that Neuser, a Great Western Bank vice president, underwent implant surgery in 1988 after diabetes rendered him impotent. Impotence, the inability to achieve and maintain a penile erection, affects about 30 million mostly older American men.
Less than a year later, a tube that channeled saline solution into a silicone cylinder in Neuser’s implant became disconnected, leaving it uninflatable, Ross said. Neuser later underwent surgery to have the implant removed, the attorney said.
The urologist who operated to remove the tube had no choice but to sever a nerve during the surgery, leaving Neuser with a permanent dysfunction, Ross said.
“When they removed it, he lost a portion of sensitivity on his penis. He has an extremely difficult time achieving sexual satisfaction . . . which has had a devastating effect on his sex life,” the attorney said of Neuser, who is separated from his wife.
An attorney for American Medical Systems could not be reached for comment late Monday afternoon, and the company’s Minnetonka, Minn., offices were closed.
Last year, AMS voluntarily recalled 212 penile pumps distributed in the United States, Europe, Canada and Australia because of possible corrosion in a stainless steel component.
In October, the company released statistics showing an 18% chance that after five years, a patient would require surgery to remove or replace its 700 CX implant, the model that Ross said was implanted in Neuser.
According to reports filed with the FDA, recipients have complained of various problems with AMS devices, including infection, deflation, fluid leaks and skin breaks.
The FDA is trying to tighten regulation of penile implants, apparently as a result of its experience with silicone breast implants, which have a high rate of complication and now are available only as part of a government-controlled study.
Like breast implants, penile implants arrived on the market before the FDA was given regulatory authority over medical devices in 1976. The agency plans to check all “high risk” devices that became available before 1976. Penile implants, because they contain silicone, are expected to be among the first to be scrutinized.
The government wants to determine whether silicone in the penile implants produces the same kind of immune system disorders caused by some breast implants.
But some doctors are concerned that the FDA is exaggerating possible problems and scaring off some patients who could benefit. According to the American Urological Assn., 80% of men with penile implants are satisfied with them.