Silicone Testicle Implants

[Guest guest]

We've had reports that men are experiencing the same

health problems with testicle implants as women with

breast implants. . ..

Maybe thousands of men getting sick will be what it

takes to get the attention of the government agencies!

I wonder if the men could save money by getting their

implants here: http://www.neuticles.com/index1.html

Question: Would you still love him if he's missing

one?

Another question . . . I wonder if the number of

implants sold in the U.S. is equal to the number of

implant surgeries reported? Or is there a lot of cash

business going on that doesn't get reported?

Based on what I see, I think the number of implanted

women in the U.S. is much, much larger than the two

million women mentioned in the CSPAN broadcast!

Rogene

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http://www.rednova.com/news/display/?id=200097 & source=r_health

Implanting Self-Image

Aug. 7--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. 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 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 & 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.

, 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, "

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, 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, " said. " I expected

the size and texture to be better. "

Pryor, who performed '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. 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. "

Pitman says the gel-filled testicle is a good year and

a half away from passing muster with the Food and Drug

Administration, which regulates medical devices.

In contrast, Mentor will likely reintroduce the gel

version of the breast implant for cosmetic purposes

later this year.

That prospect has excited Mentor investors-- and it's

the main reason the company's stock price has

skyrocketed more than 60 percent in the last year,

Gunderson said.

Late last month, Mentor said the FDA has outlined

certain conditions the company must meet to receive

final approval for its MemoryGel silicone gel-filled

implants. Gunderson estimates that it will take the

FDA another two to six months to monitor Mentor's data

and finalize approval. Inamed Corp., its only

competitor, might hit the market about three to six

months after Mentor, said Gunderson, who does not own

shares of either company.

Silicone-gel implants were banned in the United States

13 years ago after thousands of women claimed that

leaking implants had damaged their health. The product

liability was enough to force Dow Corning, a joint

venture of Dow Chemical and Corning Inc., into

bankruptcy in 1995. Many other firms abandoned the

product in the face of product liability lawsuits.

After a decade of study and some improvements that

make the implants less prone to leak, the implants are

ready to go back on the market.

Consumers are anxious for the gel version because they

think the look and feel is more natural than their

saline-filled counterparts. About three of 10 women

would switch to gel, according to a survey Gunderson

did last year.

The reintroduction of silicone gel implants should

accelerate both sales and profits at Mentor, Gunderson

said. Although the gel version costs only about 10

percent more to make than the saline version, the

company plans to charge about twice the price for it.

That's a recipe for higher sales and higher profits,

especially because there is likely to be a spike in

sales once the gel version is on the market.

Even with FDA approval, breast implants carry with

them the high-profile controversies from 13 years ago

that prompted the FDA to pull them off the market for

further study.

" There will always be lingering concern, " Pitman said.

Still, that's preferable to the key issue faced by

prosthetic testicles -- obscurity. That's a battle

Turek hopes his study on the quality of life benefits

of the prosthetic testicle will help win.

Women who lose a breast to cancer are required to be

informed that a prosthetic implant is available.

[Thanks to manufacturer lobbying of Congress]

Turek argues that the boys or men who lose a testicle

to cancer or injury should be " given the same

opportunity " by being informed of the prosthetic

testicle.

" Doctors are required by law to inform women of their

options so their quality of life can be restored, "

Turek said. " For a man, there was nothing. Men have

deserved the same option, and now there is something

for them. "

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Source: Saint Pioneer Press (St. , Minn.)