Hard Times

Penile implants are supposed to make life better for men rendered impotent by injury or sickness. Sometimes they just make matters worse.

For Bob Carson the story starts almost 20 years ago in a ditch on the side of a highway. "I was out on a service call, towing a car," he says. "I pulled off to the side of the road and was stringing the cable out and a guy rear-ended my tow truck. It hit me and ran over me."

The accident broke Carson's right hip, his right knee, and his left elbow. It ruptured his spleen, bladder, and intestines, and fractured his pelvis in four places. Three months later, once the rest of his body had begun to mend, he discovered that nerve damage in his lower back had left him impotent as well. He was 28 years old and married.

"I was [young] and pretty active, doing everything that everybody else does," Carson says. "Then finding out that you're impotent--that's a hell of an adjustment." After a series of tests, a urologist mentioned the possibility of an inflatable penile prosthesis. Composed of a fluid-filled reservoir, pump, valve, and two inflatable cylinders, the device would restore his ability to have erections. On the advice of doctors and therapists, Carson got the implant.

But after a short time, the device started malfunctioning. Erections withered without warning. Besides the humiliation he felt, Carson developed a bladder infection and urethral bleeding. During this period Carson and his wife--who had fertility difficulties--tried to conceive without success. Finally, doctors removed the device and found a failed valve and kinked tubing. They implanted another; it was his 11th operation since the accident. In 1986, after 15 years of marriage, the still-childless pair divorced.

Carson has been in semi-retirement since last summer when Hennepin County bought out his business for a highway expansion project. A second marriage ended in divorce earlier this year. These days, he does some volunteer work and fishes on a stocked lake visible from the living room window while he figures out what to do next.

He was reluctant, he says, to sue American Medical Systems, the Minnetonka-based company that had manufactured the failed prosthesis. He was already involved in other litigation involving the accident, and believed the suit would "bring up a lot of bad memories of being crunched up--which you'd like to put behind you as fast as you can." Finally, Carson believed the company was on the same side as impotent men. "Why raise any trouble with them when they're trying to help? Otherwise, your alternate choice is nothing." But he became suspicious when the removed prosthesis disappeared from the operating room, apparently returned to the company's headquarters, despite his explicit instructions to set it aside for independent examination.

In the mid-1980s Carson, along with several other Minnesota men who had failed implants, filed suit against American Medical Systems. Compared to some of them, he'd gotten off easy. One plaintiff's prosthesis suffered a total fluid loss, and then a second total fluid loss a year after that. Four months after the second correction, the implant became infected and the right cylinder eroded into his urethra. His medical reports were grisly. "There was," notes one, "a large accumulation of subsanguinous and seropurulent fluid in the subcutaneous tissue surrounding the tubing from the cylinders." Put plainly, the man's penis was filled with blood and pus. The preponderance of post-surgical scarring made the next device, a safer semi-rigid, non-hydraulic device, almost unimplantable. He would undergo five operations by the time he filed suit.

"I finally decided, if [litigation] is gonna save somebody else, it wouldn't be a bad idea," Carson explains. He says that after lengthy legal wrangling, he accepted an out-of-court settlement of roughly $5,000: "about what it would cost to have the surgery done--the second time you get it taken care of." That was the end of the legal machinations in his case, but today a growing number of implant recipients are suing AMS and other penile implant manufacturers (see sidebar), and the stakes look to be considerably higher for everyone involved.

The search for a surgically implanted treatment for impotence dates back at least 60 years. As early as 1936, doctors attempted the insertion of rib cartilage into a reconstructed penis. This solution didn't work well. Within several years, the cartilage was reabsorbed into the body. In a quarter of cases, the cartilage curled back onto itself. Non-hydraulic, rod prostheses composed of synthetic substances--known as "semi-rigid" or "malleable" implants--emerged in the 1950s. These were not absorbed by the body and could often maintain a modicum of form without buckling during intercourse. They did not, however, expand in length or width. The malleable prosthesis was never entirely erect nor entirely flaccid.

In 1972, F. Brantley Scott, a urologist at Baylor University, conducted some of the first experiments with the Inflatable Penile Prosthesis. The Scott prosthesis addressed all three problems with the malleable product: length, girth, and flaccidity. Adapted from the artificial urinary sphincter--an inflatable silicone balloon used to control incontinence--the IPP was simple in concept and effective in theory. Surgeons made an incision along the perineum (the tissue between the scrotum and the rectum) or above the pubis and, using a metal rod, destroyed erectile tissue in the corpora cavernosa--paired bodies running longitudinally down the shaft of the penis. The cylinders went here, and a valve and pump were placed in the scrotum. A reservoir, originally filled with a colored fluid called radiopaque and later with saline, fit in the lower abdomen. Tubes connected the reservoir, the pump, and the expandable cylinders. This device was the great leap forward.

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