(News) Mentor Corp re-introduces gel-filled artificial testicles
Mentor Corp. hopes the reintroduction of gel-filled artificial testicles will help restore emotional health to men who've experienced cancer or other trauma.
On the verge of being the first to offer silicone gel breast implants for cosmetic surgery since they were pulled from the market 13 years ago, Mentor Corp. also wants to bring back the equivalent implant for men: the gel-filled artificial testicle.
Some urologists argue that the prosthetic testicle, which the formerly Minneapolis-based medical device company has been selling in a saline-filled version for the past few years, has received short shrift from the medical community. Few doctors and patients even know they are available.
Dr. Paul Turek wants to change that. He set out to see if the benefits of testicular implants were deeper than just cosmetic by heading a clinical trial involving 149 implant recipients. The study, published in the October 2004 issue of the Journal of Urology, concluded that recipients enjoyed a significant boost in their quality of life.
"It's not simply cosmetic," said Turek, a urologist at the University of California-San Francisco. "We found that it can be vastly important in self-esteem and body image -- it restores men's self-image."
Mentor makes its prosthetic testicle, which is the only one approved by the U.S. Food and Drug Administration, at its complex in Minneapolis. The company was based there until 1985, when Mentor moved the headquarters to Santa Barbara, Calif., where the breast implant company it had just bought was based.
The testicle implant is one of dozens of products made at the Minnesota site, where 350 workers are spread among two manufacturing facilities, a research and development lab and an administrative office building.
Of the 10,000 to 15,000 boys and men in the potential market in any given year, fewer than one of four gets the testicular implant. Mentor hopes that by spreading the word among doctors and patients, it can reach about half of those candidates.
Turek's study has already helped, said Charlie Pitman, the product manager for Mentor's implant as well as other surgical urology and oncology products.
"Many urologists were unaware the prosthetic testicle was back on the market when they saw the Turek study," he said.
Even though Mentor has a virtual monopoly in the market, sales of the prosthetic testicle barely register a blip in sales for the company -- and will never be a big seller. The saline-filled version accounted for only a fraction of 1 percent of the company's $483 million in total sales for the most recent fiscal year, Pitman said. Even if it doubles unit sales and sells the more costly gel-filled version, sales would barely crack the 1 percent mark.
Compare that with breast implants, which accounted for $217 million -- nearly half of last year's sales. And next year, breast implant sales are expected to rise significantly with the reintroduction of the silicone gel version for breast augmentation.
The gel version has remained available for women needing reconstructive surgery after having a breast removed. The prospect of expanding the use is why most investment analysts who follow Mentor focus on the breast implant business to the exclusion of its other products.
The prosthetic testicle is one of dozens of niche products that Mentor offers as part of its portfolio, which includes penile implants to treat erectile dysfunction, urological catheters, and a variety of cosmetic implants. Mentor does not make the breast implants here.
By offering a wide array of niche products as well as standard ones, Mentor may be able to win more urologists as customers, said Thomas Gunderson, an analyst for Piper Jaffray Cos.
Still, it faces competition from dozens of urological companies competing for urologists' attention, including Twin Cities-based firms such as Medtronic, American Medical Systems and Urologix and such national firms as Johnson & Johnson and Boston Scientific.
"In competition with all the other urological companies, Mentor may gain an edge with surgeons by providing more of these types of products," Gunderson said.
The prime market for the prosthetic testicle comprises men who have had a testicle removed because of testicular cancer or other trauma, or those who were born with an undescended testicle that had to be removed, said Dr. Jon Pryor, chairman of urological surgery at the University of Minnesota.
The surgical procedure is easy, low-risk and takes from 15 minutes to 20 minutes, Pryor said. The worst thing that can happen is that the site can become infected, but then the prosthetic testicle can be removed.
"It doesn't have as much to do with health as it does with treating a disfigurement or improving the patient's psychological health," Pryor said.
Although the absence of a testicle is not quite as apparent to the casual observer as is the absence of a female breast, it can still be an issue.
"When you're in the showers at the gym, it's quite obvious you are missing a testicle," Pryor said.
The need is particularly acute among adolescent males, he said. One young man was nearly suicidal about the loss of his testicle, but largely recovered his psychological health once he received the implant, Pryor said.
"They don't feel complete -- this is a way of dealing with that," Pryor said.
Before Mentor's prosthetic testicle was back on the market, Turek said one of his patients had asked if he would implant a "neuticle," a prosthetic testicle used in dogs. He wouldn't, but it helped him recognize how desperate some men are to feel "whole" again.
"It depends on where you are in life as to how important it is to you," Pitman said.
Older men, especially those who are in happy, stable relationships, are less likely to feel the need to have the implant, Pryor said.
Charles Johnson, a 50-year-old who lives north of Minneapolis, sees himself in that category, but he decided to have the implant done anyway.
He was born with an undescended testicle, and had the testicle surgically lowered when he was 5 years old. But the testicle never felt normal, either in size or texture, and it caused him intermittent pain. About five years ago, the pain and the increased risk of cancer convinced him to have it surgically removed.
"At that time, they didn't have an implant available," Johnson said.
A couple of years later, he discovered that they were doing implants again, and he thought about getting one done.
"My wife asked me why," he said. "It didn't matter to her."
But it felt odd having just one testicle -- especially after having two for most of his life.
As it turns out, Johnson was not satisfied with either the size or the texture of the implant.
"It wasn't even close to being the same size as my other one, and it doesn't feel the same either -- it has a superball feel to it," Johnson said. "I expected the size and texture to be better."
Pryor, who performed Johnson's procedure, agrees that if there is one area of improvement Mentor should consider, it would be to offer a larger size.
Mentor plans to add a larger size when it reintroduces the silicone gel testicle, Pitman said.
Mentor sells the prosthetic testicle for $1,150. The procedure, typically done on an outpatient basis, can cost anywhere from $2,500 to $3,500. Johnson says health insurance covered all but a "few hundred dollars" of his procedure.
Shortly after the breast implant scare of the early 1990s, in which leaky implants were suspected of creating a hazard for patients, Mentor also decided to pull its silicone gel-filled prosthetic testicle off the market. Only the saline-filled version has been available in recent years.
But for testicles as for breasts, silicone gel has a more natural feel to it than saline.
"Saline has less give to it and it only compresses a certain way," Pitman said. "Gel has a more natural density to it."