Hard Times

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.  

An article in the July 1973 issue of the medical journal Urology tracked five cases in which the new device had been implanted to treat organic impotence. The results were encouraging: "Two of these patients have had sufficient post-operative follow-up to achieve successful vaginal penetration for sexual intercourse." That same year Scott, along with Gerald W. Timm (of the University of Minnesota Hospital) and two other men, founded a company in Minnetonka to make and market the artificial urinary sphincter and the inflatable penile prosthesis. That company was American Medical Systems.

Early AMS literature highlighted the advantages of the inflatable implants over others. "Full girth erection," one pamphlet claimed, "promotes the satisfaction of the patient and his partner." No less important was the converse claim: "True flaccidity helps the patient be comfortable all day... [the IPP] eliminates embarrassment with public dressing or voiding." Five years later, Scott published an article in the Journal of the American Medical Association evaluating 245 patients, and concluded, among other things, that "the prosthesis can be expected to function for at least 20 years based on mechanical testing."

Patient satisfaction over the first decade of use was remarkable: 79 to 97 percent of patients were either satisfied or highly satisfied in typical tracking studies. This was despite the fact that the glans (or head) of the penis remained floppy due to the placement of the paired cylinders within the penis, and the fact that up to 50 percent of early devices failed, requiring surgical revision or replacement. The reasons for mechanical failure were numerous.

High "intraluminal pressure"--involving the fluid in the reservoir, connecting tubes, and cylinders--caused leaks, ruptures, and valve malfunction. Actual intercourse appeared to heighten the pressure load on the prosthesis and the potential for failure. The connections between components proved particularly susceptible to leakage, and on top of that cylinders commonly developed aneurysms. IPPs likewise could fail to inflate at all, for various reasons--fluid drainage, kinked tubes, broken pumps. The occasional pump made a flatulent sound during inflation. In other cases, unequal cylinder inflation caused the penis to angle off to one side. Malfunctioning valves caused autodeflation during use or autoinflation when not in use. Professionals called the latter case "untimely" or "spontaneous" erection.

Uglier than these cases were incidents of surgical infection and corporeal erosion, both of which demanded prompt and serious attention. The latter occurred when a cylinder (often mis-sized) pierced through the tissue surrounding the corpora cavernosa, perforating the urethra, the glans, or the skin. Occasionally a piece of the silicone coating could be seen peeking out the opening at the end of the penis. Cases in which the pump eroded into the scrotum, or the fluid reservoir into the bladder or bowel, were also encountered; the tissue next to these components sometimes broke down, leading to tissue loss and infection.

Over 20 years after its founding, AMS--since 1985 a wholly owned subsidiary of the pharmaceutical leviathan Pfizer--manufactures a full array of penile prostheses. There is the 650 model, which is not an inflatable prosthesis but actually a pair of malleable rods. The Dynaflex is a "one-piece" model comprised of paired cylinders with built-in reservoirs; squeezing the pump at the head of the penis inflates the cylinders, and bending the penis over the thumb for five seconds deflates them. The two-piece Ambicore consists of paired cylinders with a self-contained reservoir and a pump located in the scrotum. The three-piece 700 series--the top-of-the-line prosthesis--comes in many related incarnations: the CX, the CXM, the Ultrex, the Ultrex Plus. These devices feature a scrotal pump and release valve, and include a separate reservoir that stores fluid in a small silicone balloon in the lower abdomen. Most of these wholesale to hospitals for about $4,000; the surgical procedure costs the patient $10,000-$15,000, depending on the length of hospitalization and other variables. Fixing what is clinically known as "erectile dysfunction" doesn't come cheap.

Clinical studies suggest that contemporary IPPs are more reliable than those they replaced. The product lines described above can accommodate rounded rear-tip extenders for superior fit, which serve to reduce the incidence of migration, extrusion, and erosion. Pre-assembled connections reduce the probability of leakage at joint sites. The CX and CXM expand in girth only; the latter is appropriate for patients with smaller and narrower phallic anatomy. Statistics released by AMS reflect the effects of these modifications, suggesting that now, at most, 18 percent of implant patients undergo surgical revision or replacement within five years. The rate of total failures--including those not repaired and thus not recorded--could potentially be higher. The technical jargon of each improved product line has its own mechanical poetry. Biocompatible and rupture-resistant materials. Dip-coated seamless reservoirs. Controllable girth expansion.  

Max Smith lost sensation in his penis in 1976, after the first in a series of back operations that eventually forced him into a medical retirement. "The doctor told me feeling would come back in six months," the 60-year-old Iowa man says. "Well it came back, and then went away again. First I couldn't get a full erection. Then all of a sudden I couldn't get one at all." In the meantime, Smith's spinal injury began causing him to void blood.

Smith's sexual relations with his wife became less and less frequent, while changing in nature as well. "When I was impotent," Smith explains, "having sex was mostly being close to each other. It was nothing like having regular sex." Smith's doctor prescribed testosterone pills to stimulate his erectile function, but "they really didn't work that good." One doctor diagnosed a double-hernia as contributing to Smith's impotence, and began treating him with vitamin E supplements. Another doctor convinced Smith that the hernia diagnosis was bunk. "Finally," Smith says, "I figured enough was enough." In December 1992, after a decade of intermittent impotence, the retired welder was implanted with an AMS penile prosthesis.

"I had problems right from the beginning," Smith explains. "The swelling took about two weeks to go down. The scrotum was black and blue and [my testicles were] as big as basketballs. And my penis was about four inches in diameter. It looked like a little stub there... It was sort of painful, you know?" Once the swelling receded, and pubic hair shaved for the surgery grew back, little sign of the device remained. "You've just got one little scar below your belly button," Smith says. "About three inches. You really can't see it. When you inflate [the device] you have a regular erection."

But by June 1993, six months after the surgery, a leak in the prosthesis prevented it from inflating properly. Urination became painful. Although the saline that fills the device is not supposed to irritate the body, Smith, like other men with leaking implants, had bad experiences with it. "I got awful sick," he says. "I got real bad stomach aches." Soon, the prosthesis failed to inflate at all.

That same month, Smith had his first device removed and an AMS Ultrex implanted. Yet within a month, Smith says he encountered an equally unappealing problem with his prosthesis: It began to inflate spontaneously. Several times in the next few months, Smith was forced to return to the doctor when he could not detumesce an erection himself with the scrotal valve. Since then, spontaneous and unwanted erections have continued to aggravate Smith. "I have to put it down four or five times a day," he says. "In the summertime, I like to walk around in shorts and jogging pants and now I can't do that."

Smith finds this problem particularly embarrassing in public. "If you came over with your wife for a visit, [and] I got up and the thing would be sticking out--you'd think, what does this guy have on his mind? I could be in church and all of a sudden the thing will go up in the air." Smith's doctor suggested the problem "would correct itself." It didn't. At the same time, Smith developed difficulties urinating: "I stand there, and I wait and I wait and I wait." A doctor examined Smith's prostate--a common source of urinary problems in older men--and found nothing awry. Surprisingly, Smith seems largely unfazed by his daily difficulties with unwanted erections and urinary discomfort. "What are you going to do?" he asks. "It's almost getting to be a way of life.

"If I was a teenager I would have loved it," Smith jokes. But as is, the autoinflation has caused more trouble than the impotence it was designed to correct. Smith modestly gropes for polite words to describe his current sexual experience. "As far as having sexual contact, it's not like it used to be when I was younger. And now I have [the implant] and it's gotten to the point that the thing is always going up on me and I don't even have sex. I sleep in a different room than my wife sleeps, because I don't want to be bothered.  

"My wife is going through it all too," he explains. "She isn't real happy. But we got married young; she was 16 and I was 18. She's a one-man woman. She's understood. She's said to me, whatever will happen will happen. She just wants me to get better." Smith is less willing to talk about his prosthesis with friends and other family. For instance, he dislikes going out to dinner with his three adult sons. "My kids don't even know I got this in me," Smith says. He's embarrassed when his sons ask about his long disappearances from the table--times when he heads to the bathroom to deflate a spontaneous erection. "I wouldn't even tell them. You know how boys are. They like to kid around about stuff like that."

Like many other men with malfunctioning prostheses, Smith is reluctant to undergo yet another uncomfortable operation on his penis, facing the choice of either installing another potentially flawed prosthesis or leaving cavities to re-accumulate tissue--thus complicating the implantation of any future device. For now, Smith tries to forget about the implant: "When it's deflated and it's comfortable I just don't want to disturb it." Smith filed suit in federal district court after finding an advertisement in a newspaper for lawyers seeking to represent men with failed IPPs. "I figured I went through so much garbage, hey, what the hell?" Unlike many men who have enjoyed restored sexual function with a prosthesis before encountering complications, Smith regrets ever having followed the recommendation of his doctor. "To tell you the truth, I think it was the sorriest day of my life."

By some estimates, approximately 20 million men suffer chronic impotence. American Medical Systems estimates that number is closer to 30 million. More than half of impotence cases involve organic (as opposed to psychological) complications. The sources of erectile dysfunction are many. Topping the list is diabetes, which affects approximately 2 million men; half of those may become impotent after age 50. Spinal cord injuries, pelvic injuries, and other back problems can damage the nerves that control both erection and orgasm. Prostate cancer and its treatment can result in impotence. Prescribed medications--particularly sedatives, tranquilizers, and antihypertensives--can interfere with erectile function. Alcohol, cigarettes, and obesity have all been implicated as well.

As few as 5 percent of men who are impotent seek treatment. Jon Pryor, a urologist at the University of Minnesota Medical School, sees these patients. While he does not recommend the inflatable penile prosthesis for cases of "psychogenic" impotence, Pryor has implanted over 100 devices in the last five years. He considers the IPP a treatment of last resort. Before implanting one, Pryor will have exhausted any number of alternate treatments.

Those treatments are varied. Testosterone patches can be applied daily to the shaved scrotum to boost hormone levels. Vacuum constriction devices induce blood into the penis with an external pump; an elastic band holds the blood there. Penile injections (the technical term is vasoactive intracorporal pharmacotherapy) can effect an erection for an hour, or two, or three--lasting even after orgasm. The tastefully illustrated promotional literature for these products alternates between upbeat abstractions and sobering side effects. (In the case of injections, these include scarring, liver toxicity, and priapism.) "Each of us dreams of experiencing life as fully as possible," one pamphlet coos. "Testosterone deficiency can interfere with this." Another explains that "the process of injection can be included in sexual relations, especially between caring and committed partners."

Pryor resists characterizing the inflatable penile prosthesis as a panacea--although according to patient complaints, some physicians do. Pryor tells patients about the failure timetable for the penile prostheses: "Twenty percent of these will malfunction by year five; I tell all my patients to expect to replace it within 10 years." Still, his experience with the AMS prosthetic line is a positive one. "I find that by and large the patients are very happy with them. If you promise them it's going to be as good as when they were 15, they're going to be disappointed. [But] prostheses have helped people. They really do. Is it a perfect treatment? No. But when you think about it, if these patients didn't have a prosthesis, most of them would just not have intercourse.

"Have you ever seen these prostheses?" Pryor asks. He walks into a back room and emerges with an armful of devices: malleable, one-piece, two-piece, three-piece. A two-piece, the Ambicore, is packed in a clear, fluid-filled pouch. A couple of the one-piece Dynaflexes bob in a jar like plastic pickles in brine. Examining the thin white rods, it is difficult to imagine what accounts for the approximately $4,000 price tag.  

Pryor does not describe the incidents of product failure or bodily infection in the same terms as some of the men who encounter them. They tell tales of one, two, even five or six arduous surgeries. Pryor says that any subsequent surgeries are far less traumatic than the first. He says that the swelling of the penis which can accompany such surgery--all the way to "grapefruit" dimensions--is a common risk with even routine urological procedures like vasectomies. Infections are always a working risk, he says, and impotent men are often already unhealthy. For instance, the circulation difficulties common to diabetics and to men with Peyronie's disease (a gnarling of the veins in the penis) can weaken tissue and contribute to "erosion." Yet according to Pryor, and many other accounts, patients gladly undergo surgical revision or replacement of their prostheses, frequently selecting the same device.

They often do so in the face of enormous discomfort. There is this, from the deposition of a St. Paul man taken a decade ago: "For three or four weeks after each surgery, I was in substantial pain to the point that wearing pants was difficult and sometimes impossible. I suffered depression after each prosthesis failed. All that I could think of was having to go through another painful operation."

Pryor compares the mechanical malfunction of a prosthesis to that of a car: Sooner or later, machines break down. "There is no question in my mind that AMS does whatever it can to prevent these things from malfunctioning," he says, citing a litany of product enhancements and their measurable improvement of reliability rates. "After all," he continues, "it's in [the company's] best interest to make sure that they don't malfunction. Will there be changes in the future? Absolutely. It always is getting better."

Tim Williams has gone through four American Medical System penile prostheses since the late 1980s. Williams, a retired Midwestern blue collar worker in his 50s, believes he may have contracted Peyronie's disease and its attendant phallic curvature after a urinary catheter tube got caught in his hospital bed following open heart surgery, inflicting a wound. After an operation that failed to correct the angulation, Williams reports having lost two-and-a-half inches of length at full erection as a result of scarring. While Williams had not encountered impotence, the curvature made sex uncomfortable. "It hurt me and it hurt my wife," Williams says. Afraid that his penis might shorten again after surgery ("If I keep on losing length I'll end up with nothing"), Williams's choice to get an implant seemed to be an easy one. He never asked about the function of the device. "They didn't even talk about that," he says.

Despite some loss of sensation during sex, Williams describes mixed results with the device during the two and a half years when it worked. "It's not the same feeling," he starts, before trailing off. "You lose sensitivity to a point--unless it's infected, then everything you touch [makes] it hurt." The infection arrived in 1993, after a connection between the pump and cylinder broke. And while the saline fluid that leaked from the tube is supposed to be biocompatible, Williams's infection appeared on the affected side of his penis; when the device was removed, he says, "pus just poured out." In May 1993 an AMS Ultrex was implanted. Three months later, another infection forced the removal of that device. From this point, Williams's many medical procedures begin to blur together. "I think they tried another one," he says before pausing. "It's so confusing that I'd probably have to look at the records."

Current AMS product literature is emphatic in its recommendation that patients discuss all aspects of a prosthesis with a doctor. Yet one might be surprised how little most patients seem to know about their prostheses and the possibility of complications. Of the men contacted for this story, none knew the model of any implants he'd received, or their specific features. Twenty years after his first implant, Bob Carson believes he was used as a "guinea pig" to test an unproven product. "I don't remember if they even told me about longevity; I don't know if I ever even asked." The same appears true when it came to the discussion of the dangers of the device. "It never dawned on me," Carson says. "There wasn't a whole lot ever said about it. I really don't know why... [The doctors] definitely wanted me to go ahead with the program and didn't want to discourage me in any way."  

According to Carson, he was easily convinced of the merits of a prosthesis. And when the device worked, it indeed offered a reasonable simulation of normal intercourse. "I was overjoyed that something could be done for me," he says. "I spoke to other men--men with diabetes who had already gone through a lot of surgery. More surgery [after an implant failure] was something we didn't think about. I don't think we wanted to think about it."

No one may be surprised that impotent men seem particularly susceptible to any offer to restore their virility. What may be more difficult to believe are charges that AMS deliberately misled doctors, consumers and the Food and Drug Administration about the safety of their product line and the incidence of failure. Yet hundreds of outstanding cases against the company forward allegations like these in no small detail: from absent or incomplete discussions of longevity expectations in patient and doctor literature to AMS's alleged refusal to adequately report incidence of product failure to the FDA as required by law--a policy that one suit calls "a systematic and intentional pattern of deceit and fraud." Attorney William J. Morton--a lawyer and urologist, and the Chair of the American Trial Lawyer's Association Penile Implant Litigation Group--believes that urologists themselves don't know the facts. "The problem with all these guys," Morton says, "number one, they all hate lawyers; they all hate lawsuits. And they don't really know. The doctors have been duped."

AMS spokeswoman Denise Ulrich categorically denies all these charges. "We didn't go around telling people be careful be careful be careful because there's a possibility it may fail," Ulrich says, "but we certainly didn't hide that fact either." She points to the many clinical trials available to physicians, while attributing some measure of patient dissatisfaction to shifts in the society at large. "Ten years ago," Ulrich says, "the kinds of warnings and precautions on a toaster were very different than what you see now. Our society is changing a little bit as to what the expectations are." And, in fact, AMS is now conscientious about distributing comprehensive warnings that include life-expectancy data for their product line.

This information might have come too late for Tim Williams, who learned of the dangers of his implant only after the fact. "I never had the literature," Williams says. He believes doctors misled him every step of the way. "[First you] lose length when you didn't think you was going to lose it. Then you think that you're getting things cured by letting them talk you into having another one in, [and] you get nothing but infection. How many times do you have to be cut on before they can get something to work?"

Only after visiting doctors in Nashville and Indianapolis did Williams learn of other available treatment options--some of which could not be attempted after his various operations. For Williams, the costs of the device eventually went beyond the scars and the insurance bills. "It cost me a marriage," he states, matter of factly. "Our sex kinda went downhill. My wife said it just don't feel natural for her." While Williams's fourth implant has functioned for nearly a year, the ordeal continues in more than just the courts. "It sticks in your mind," he says, "what you used to be like and what you ain't like no more."

Bob Carson is more circumspect in considering the role of the prosthesis in the dissolution of his marriage. "It definitely didn't help us any," he says. "The embarrassment of having it drove a wedge between us. When I look back on it, the subject of sex was probably more difficult for me than it was for her."

Still, Carson's case can claim something of a happy ending. In 1990, 12 years after his first implant, Carson's nerve endings reattached, restoring his natural erectile function. The prosthesis remains implanted. Carson intends to leave it there indefinitely.

What Carson and Williams seem to share at this point is a mistrust of the medical system, and of the cure for erectile dysfunction that in their cases proved too good to be true. They aren't alone in their troubles with IPPs. Since January 1991, AMS has filed more than 17,000 Medical Device Reports--typically involving some manner of product failure or malfunction--with the FDA. And according to Ulrich, more men are being fitted with AMS prostheses each year.

"We thought doctors were doing these things in our best interest," Carson says. "I never thought of medicine as being a business. I was naive then. I'm not now."

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