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Fred Colelli used to consider himself a regular Don Juan.xxxxxxxxxxxxxxxxxxxxxxxxx

“I was very, very, very active sexually,” says the 68-year-old.

Active, that is, until August 1994, when he had a penile implant installed to treat a rare erectile problem. Although penile implants are generally used to treat problems of impotence, Colelli will tell you in no uncertain terms that he had had no problem sustaining erections prior to his surgery. He opted for the implant because his penis curved at a 45-degree angle as a result of a rare affliction called Peyronie’s disease. Although his organ was fully operational, the bend made his partner uncomfortable during intercourse, so he opted for surgical intervention.

What happened next sounds like a crude barroom joke. After the device was installed in the operating room, he couldn’t get it to deflate. His surgeon managed to get it to go down, after a two-week waiting period, but only after a struggle. By the time Colelli got to the hospital elevator, however, it was back up again. He had to cover his obviously bulging unit with a newspaper on the bus ride home. Colelli called the manufacturer, and a sympathetic executive there FedExed him a video on how to operate the apparatus, but Colelli still couldn’t get it down and the pain became more excruciating. He says the problem became so painful he contemplated jumping off a bridge.

Colelli, who lives in Pittsburgh, went to see specialist after specialist without success. After three months of chronic pain, he had his defective implant removed—and his manhood went with it. Nowadays, “You could hit my penis with a sledgehammer and I wouldn’t feel it,” he says. What’s left of his surgically altered appendage is smaller than his pinkie.

His penis, he says, has “basically disappeared,” but adds, “I must say I was kind of proud of what I did have.”

Colelli’s story might spark some smirking around the water cooler, but there’s really nothing funny about it. Thirty million American men are afflicted with some form of impotence, and over 250,000 men have turned to penile implants as a fix. A sizable number of them—at least 10 percent—have found that what they had hoped was an answer to their prayers has left them with a useless device occupying some very precious real estate.

Don Bulmer wanted to cure his tendency toward brief erections, so he had an inflatable prosthesis put in at Washington Veteran’s Hospital. His problem was the opposite of Colelli’s: After five revision surgeries over three years, he still could not get the device to inflate. He finally had it removed.

“It may seem unbelievable what guys will go through to have sex again,” Bulmer says. “But that’s a big part of a man’s life.”

Another Washington-area man who didn’t want his name used had hoped an implant installed in 1991 would fortify his flagging lily, which was ailing as a result of diabetes and a heart condition. But his device neither goes up all the way—nor down all the way. It’s a soft-on, stuck somewhere in the middle. “We still can have intercourse, but it’s not what we expected it to be,” he says. Both he and his wife based their expectations in part on a promotional video they viewed in the doctor’s office. “Let’s just say my wife told me it wasn’t like what we saw in the video.”

Inflatable penile implants were touted as a sure-fire cure for hard-to-treat cases of impotence. But instead of sowing marital harmony, some of the devices have been quietly wreaking havoc in bedrooms across the country. More than 25,000 device failures have been reported to the U.S. Food and Drug Administration (FDA) in Gaithersburg, Md. Many other men are likely suffering in silence.

But Colelli, Bulmer, and hundreds of other men with failed implants nationwide aren’t going to take the shaft lying down; they are suing the maker of the implants for damages to their most precious asset. The plaintiffs have retained Washington attorney Lewis Saul to confront the manufacturer of their devices, American Medical Systems Inc. (AMS), a fully owned subsidiary of Pfizer. The plaintiffs allege that AMS knowingly made and marketed defective devices—and failed to warn doctors and patients of the risks. Saul may not be able to retrieve their manhood, but he’s hoping to make AMS pay a pretty penny for allegedly taking it away.

“The devices have much, much lower success rates than advertised, and satisfaction rates are much lower,” says Saul, who says his 300 cases make him the nation’s leading attorney in penile implant litigation. Saul is waging a war on AMS from his upper-Wisconsin Avenue office, across from Mazza Gallerie. The only thing vaguely phallic in his office is an 8-foot art-deco replica of the Statue of Liberty. He believes that when AMS put an inadequately tested product on the market, the company robbed many men of their sexual freedom.

Colelli and Bulmer aren’t even Saul’s toughest cases. A few of the plaintiffs have lost their penises entirely to infection. And Saul claims that the device led one man to suicide. When a penile implant goes awry, a host of other complications can arise: spontaneous inflation, erosion or migration of the implant, scar tissue buildup, chronic pain, and sensory loss. Most of these problems eventually lead to the device’s removal, which leaves the man worse off than before.

“Implants should be considered irreversible,” Saul says, because of damage to the natural erection system on installation. “Once you have an implant, you can’t have sexual relations without an implant,” Saul explains.

Saul has become the master of disaster when it comes to penile implants after years of getting weaned on litigation over altered breasts that didn’t live up to expectations. Many women sued manufacturers of breast implants after the devices began leaking, sometimes sparking catastrophic infections. He got his start in penis suits after he attended the American Trial Lawyers Association annual meeting in 1993, where he heard penile implant horror stories that pricked his professional interest. For Saul, it was a natural transition. Breasts and penises are both sources of sexual gratification, insecurity, and no small amount of vanity. But getting your penis overhauled is a little more complicated than lifting and separating. The penile version of an implant has movable parts that are often installed in both the testes and the shaft. To do the job, the device has to inflate on demand. And, hopefully, at some convenient point, deflate.

Problems with penile implants haven’t attracted the media attention breast implants have, despite the fact that penile implants seem to be failing at very high rates.

“Society has a more difficult time talking about penises than breasts,” Saul surmises. To date, Saul, who works on a contingency basis, has settled about 80 penile implant cases against manufacturers, for undisclosed sums. Saul, along with other attorneys, was able to certify the plaintiffs as a class action in a Cincinnati, Ohio, court, but AMS appealed and the class was decertified. A declaration of a class of plaintiffs would have allowed the current plaintiffs’ lawyers to sue on behalf of thousands of others. Saul and his associates did manage to have the cases consolidated into a single case in Minnesota that will likely go to trial in 1998 and include the company’s entire line of penile devices marketed over its past 20 years in the business. AMS dominates the market; its penis boosters have been implanted in more than 150,000 men.

Saul is also battling AMS and Pfizer close to home, spearheading a class-action fight for D.C. residents who had any surgery in a local hospital involving a Hydroflex penile prosthesis that failed. AMS began manufacturing and marketing the Hydroflex in 1985. Saul considers it “an especially faulty device” that was not replaced until the Dynaflex model debuted in 1990. Saul advertised in the Washington Post and the Washington Times to recruit local clients. Dozens of potential plaintiffs responded.

Bulmer was one of them. His Hydroflex device was first implanted at Washington Veteran’s Hospital in 1979, before AMS widely marketed the product. For each of his six operations, the surgeons had to go through his lower abdomen, closing the incision with some 30-plus stitches every time.

“I think I was a guinea pig, really,” says Bulmer, a 72-year-old World War II veteran who has epilepsy as a result of a B-17 bomber crash in 1942. But his penis perils made going down with the plane pale in comparison. “I deserve seven purple hearts for what I went through,” he says.

AMS refuses to comment on the specifics of the pending litigation. “It’s company policy that anything of a legal nature is reserved for the courtroom,” says AMS spokesperson Denise Ulrich.

Saul, on the other hand, sees opportunity in talking up a problem most people aren’t interested in hearing about. Product liability lawyers have a reputation as predatory creatures who feed off others’ misfortune, but Saul comes across as a mild-mannered, straightforward guy with few pretensions about his trade. And he doesn’t have to stifle any Beavisesque giggles when he uses the term “penile implant.” “This is just what I do for a living,” he says. “They’re just devices.”

Law is actually a second career for the Connecticut-born Saul, who is now 48. His office showcases some of his works from his days as a painter and potter, an avocation he was forced to relegate to a hobby after he found himself with four kids and few willing buyers. Saul was barely out of George Mason University Law School when he developed an interest in product liability litigation. A friend of his became sterile after wearing a Dalkon Shield, a devilish-looking intrauterine contraceptive device. At the time, the FDA didn’t require the kind of testing of contraceptive devices that other medical applications were routinely subjected to. Eventually it was discovered that the string attached to the device had a tendency to wick bacteria up into the uterus. Tens of thousands of women contracted pelvic inflammatory disease, many became sterile as a result of the device, and 18 women died. “One thing led to another, and eventually I was representing 500 clients,” he says. Nearly 200,000 women filed claims against the manufacturer; they were eventually settled.

Much like the Dalkon Shield, inflatable penile implants made it to the market without extensive testing. Both were on the market before the 1976 Medical Device Amendments were made to the Food, Drug, and Cosmetic Act, which gave the FDA regulatory control over medical devices. Under the law, penile implants were essentially grandfathered: They were allowed to stay on the market with the understanding that the FDA would later require manufacturers to demonstrate their safety and effectiveness.

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But the FDA has acted very slowly. Penile implants have been available since the early 1970s, and the agency didn’t consider reviewing them until the spring of 1993. “I don’t commend the FDA for the speed with which they’ve dealt with this. They still haven’t published a final rule, when it should have been done 15 years ago,” Saul says. Saul points out that after a similar review in 1992, silicone-gel breast implants were taken off the market.

The FDA expects to issue a final regulation in early 1998 that would require a comprehensive pre-market approval process for the devices, according to Sharon Snider, an FDA spokesperson. “We have had concerns about the numbers of complaints with these devices,” she says. AMS, says Ulrich, insists it has complied with current FDA regulations for revising and changing product lines.

A stalwart phallus is the universal

symbol of power. The eternally rock-hard Washington Monument provides towering visual evidence of our culture’s fascination with the male member. It’s no surprise, then, that impotence is unmentionable in polite company. Not only does the affliction obliterate performance in the bedroom, it eats at a man’s self-confidence and sense of self-worth. “Impotence is really embarrassing. A man feels like he’s not a man anymore,” says Bulmer, who to this day doesn’t know the cause of his particular case.

Largely due to social stigma and embarrassment, “A lot of men go untreated,” says Leroy M. Nyberg Jr., director of the National Institutes of Health’s (NIH’s) urology programs. NIH estimates that somewhere between 10 and 30 million American men suffer from impotence, which is defined as a consistent inability to sustain an erection sufficient for sexual intercourse. Although impotence is not an inevitable part of aging, its incidence rises with age. By age 65, about 20 percent of men have experienced impotence.

The inability to rise on cue is usually caused by an underlying physical condition, such as kidney disease, multiple sclerosis, or circulatory abnormalities like arteriosclerosis or vascular disease. Up to 50 percent of men with diabetes, for instance, experience impotence. Surgery or injury to the prostate, bladder, pelvis, or rectum can damage key nerves and tissues involved in erections and lead to impotence. Many drugs, including blood pressure medications, anti-depressants, ulcer drugs, tranquilizers, and street drugs, often produce impotence as a side effect. Alcohol and nicotine can also be problematic. Psychological factors are estimated to be the primary cause of only about 10 to 20 percent of impotence cases. Ultimately, Nyberg says, “We don’t know the real underlying cause.”

A hard-on may seem like a simple enough affair, but getting it up requires complex interplay between brain stimuli, nerve impulses, blood vessel function, and hormone levels, a ballet of physiology that still baffles researchers. Even if they lack an underlying understanding of its causes, scientists have managed to produce new and better treatments over the past three decades. Penile implants are not the treatment of choice for garden-variety impotence. A guy has to be in serious distress to allow anyone to cut his penis, let alone insert complicated machinery into it. Not surprisingly, as failure rates have become more broadly known in the medical community, the use of penile implants is declining. “They are being used less frequently these days,” Nyberg says. “The trend is toward nonoperative management of impotence.” Drugs can have profound effects in some patients, while others use exterior mechanical devices such as vacuums to get their penises to stand at attention.

While popping a pill to get erect works for some men, the available drugs are not always effective. Creams sometimes work to help sustain an erection, but the leading alternative is to take a syringe and inject drugs like asprostadil and papaverine hydrochloride to restore potency by dilating blood vessels. Asprostadil can also be administered in a suppository form. The downside is obvious—once the bearer has used his erect penis for the only thing it’s good for, he wants it to return to its naturally flaccid state. Injections and creams can cause prolonged erections, which can be painful and cause scarring of penile tissue.

Some 100,000 otherwise limp penises rely on external vacuum devices to get hard by drawing blood into the penis. The cylindrical apparatus is used in tandem with a constriction band to maintain the erection for up to a half-hour. Vascular surgery to repair restricted arteries or leaky blood vessels in the penis also helps some men.

The alternatives have not advanced enough to render inflatable implants obsolete, however. “There will always be a place for penile implants in the man who doesn’t respond to drugs,” Nyberg says. Though the latest injections are effective in 80 to 90 percent of men, more than 25,000 still choose implants every year. For some, the one-time trauma of having a device implanted beats the alternative. “There was no way I was going to stick a needle in my penis every time I wanted to do it. I already was injecting myself in the arm every day for diabetes,” says one District implant user.

The goal of obtaining sustainable erections in impotent men has received a fair amount of effort over the years. Surgeons began experimenting in the 1930s with methods to produce artificial erections. The first prosthesis was actually a rib graft, which led to the implantation of the first synthetic material in the penis in 1950. In the wake of the Vietnam War, research was stepped up to assist American soldiers coming home maimed and mutilated.

When they work, modern-day inflatable penile implants represent an engineering minimarvel. Fully pumped, as Hans and Franz would say, the devices have the same internal pressure as that of an automobile tire—about 30 pounds per square inch. And during sexual congress, the devices—which are made of silicone rubber or polyurethane rubber—undergo additional external pressure. The wear and tear is obviously substantial.

“The technology has advanced phenomenally—having learned a lot from early failures,” says Nyberg. “It’s a very difficult device to make.”

The inflatable or hydraulic implants, which run from $10,000 to $15,000 including installation, typically consist of three parts: a twin set of inflatable cylinders inserted into the shaft of the penis, a pump placed in the scrotum, and a reservoir of saline solution stowed under the abdominal muscles. The entire apparatus is implanted through a small incision at the base of the penis, where it joins the scrotum. Once in place, the rubbery device theoretically provides erections on demand. The user rapidly squeezes the pump nestled in his balls, forcing fluid from the reservoir into the shaft and expanding the twin cylinders.

The man can stay firmly inflated for as long as he or his partner desires, and if things are working right, he can even come—many implant wearers have the capacity for ejaculation if no nerve injury has occurred during implantation. In theory, the pump is simply squeezed again to deflate.

Other hydraulic models have two parts and suspend the reservoir in the scrotum. Still others house all the components within the penis itself and inflate when the tip of the penis is massaged. There are also nonhydraulic semirigid and malleable implants that consist of permanently stiff rods that can be folded out of the way when not in use. The noninflatable devices involve less risk because they have no moving parts but are more unsightly and can cause embarrassment in locker rooms and the like, as the man essentially has a perma-hard-on.

Unlike silicone counterparts installed in women’s breasts, penile implants usually diminish in size over time. Even with inflatables, the erection is generally smaller: about an inch or two shorter in length than a natural one, along with a diminished circumference. The erection is also less rigid than a natural hard-on, and the head of the penis is softer, according to Bernie Zilbergeld, author of The New Male Sexuality. “An implant will change only the stiffness of your penis, not your personality, behavior, or lovemaking technique,” Zilbergeld writes. “And it most certainly will not save a failing relationship.”

Although both of the inflatable AMS devices implanted in Don Bulmer eventually failed, one of the devices worked for a year or so, and during that time he was pleased with the erection it generated. “It was just about natural,” he says. “When you lose everything and [then] can actually do it, it’s unreal.”

Attorney Saul has nothing against restoring men’s sexual prowess. “The concept of helping men achieve erection is a good concept if it can be done in a moral and effective way,” Saul says. Saul charges that AMS, “a company that’s selling hope,” was negligent in development of the devices and failed to adequately inform his clients of the risks associated with them.

F. Brantley Scott, who co-founded AMS in 1972 and is one of the pioneers of the inflatable penile implant, hawked his inflatable wares on the Phil Donahue show in July 1979. Scott told the audience that he got interested in implants while treating paraplegics during his days as a physician in a veterans hospital. He went on to become the head of the urology department at Baylor College of Medicine in Houston. On the show, he claimed that the inflatable devices produced an erection “indistinguishable from a normal erection.” At the time, Scott was still a partner in AMS, which was bought out by the corporate Goliath Pfizer in 1985.

In response to an audience question about how long the devices would last, Scott downplayed the risks: “Unfortunately, we really don’t know. We’ll know a lifetime from now whether or not it will last a lifetime. Some of the bench testing with silicone rubber, which is a very inert material, would indicate that at least probably the majority of the implants will last the lifetime of the patient. Fortunately, however, if there is a problem, it’s usually relatively minor surgery to make a correction, and we’ve done that.”

Today, AMS claims it has never made any guarantees about the life expectancy, success, or satisfaction rates of its devices. In addition, the company says, data on revision and replacements has been easy to access. “The information has always been readily available in the literature to any physician working with the product,” says AMS’s Ulrich.

Between the lines, AMS likes to imply that if there is a problem with the machine, it probably has something to do with the person who installed it. “Each surgeon has a different success rate with this, as well as with any other surgical procedure,” Ulrich says.

Saul charges that AMS has been less than forthcoming with actual failure rates. “Many of the doctors are not told the full truth. The medical community is being misled,” Saul says. For starters, AMS was cited several times in the late ’80s for failing to report device failures and revision surgeries to the FDA, and it has never released long-term follow-up data on the devices.

The body of medical literature on penile implants is incomplete and difficult to interpret, in part because the devices are constantly under revision. New models are introduced before the medical community gets a handle on the efficacy rates of the ones currently in use. Saul says that in depositions doctors across the board say they’re not aware of the failure rates. “How’s the doctor supposed to be aware? They only know by clinical experience,” he says. “And how are the patients supposed to know if the doctors don’t know?” Saul asks.

It wasn’t until 1993 that AMS put out a pamphlet formally disclosing overall revision rates of its latest inflatable devices. The information has also been available on its web page since May of this year. For the AMS 700 CX, a three-part device, the company reports a revision and replacement rate of 8 percent within the first five years. For the AMS 700 Ultrex, another three-parter, the rate is 10 percent within two years. And for the Dynaflex, which is a hydraulic device contained within the penis and activated by tip massage, it reports a 9 percent rate within three years. In the fine print, the company acknowledges that these are only average failure rates and that they do not include devices that had not yet been removed at the time of the study. “The reality is they are mechanical devices,” Ulrich says, the implication being that even the best machines occasionally succumb to stress.

Colelli, like hundreds of other patients who are part of Saul’s national case, claims he was never properly warned of the real risks. “They never told me I would be impotent,” says Colelli. “I wasn’t informed about the outcome. I was told of the positive outcomes only.”

Men who are living with impotence tend to trust what they are being told. “I was told that the device was the best one on the market at the time,” says one Washingtonian whose implant is stuck in limp limbo.

Saul charges that AMS used men in its target market as guinea pigs. “AMS engaged in human engineering instead of investing in research and development,” Saul says. “These devices are all bound to fail at some point.”

“When the devices first came into being, [the failure rates] were very high,” agrees NIH’s Nyberg. “But you have to look at it as when the failures occurred.” Technology has since improved, Nyberg says, and “the devices have a high mechanical success rate. Whether the patient or partner satisfaction is as high is hard to tell.” Unprompted, Nyberg adds that he personally has no experience with or need for an implant.

The devices may be working much better today, Saul acknowledges, but “the technology clearly wasn’t there when they started marketing [them].” And in fact, Saul has some clients with failed devices implanted within the last year.

The National Library of Medicine in Bethesda in a 1990 video details the one- to three-hour implant surgery. Penile pioneer Scott, who by then had left AMS and is now deceased, appears on the tape. “Restoring quality of life in the bedroom has been a satisfying experience for the surgeon, the patient, and his wife,” he says. “Try it; you’ll like it.”CP