To: Mark McClellan MD; David LePay; Bernard A. Schwetz
Subject: "Orgasmatron" implant experiment_legitimate or dubious?
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Contact: Vera Hassner Sharav
The FDA has approved what one can only call a bizarre expriment
to test a surgically implanted device (orgasmatron) in the spine,
of women--ostensibly to treat "sexual dysfunction."
To implant the device, "wires connected to a battery pack are inserted
through the skin and into the woman's spinal cord."
According to The New Scientist, there are few--indeed only one--volunteer.
During that operation, "the patient began exclaiming emphatically."
The volunteer is kept awake during this painful surgical procedure.
This dubious experiment leads us to wonder about the FDA's standards
for justifying such a drastic experimental procedure whose attendant risks
discomfort outweigh the unproven benefits for what is, at best, a
possibly spurious diagnosis.
The New Scientist
Orgasmatron inventor seeks female volunteers
10:44 27 November 03
Exclusive from New Scientist Print Edition.
Women who cannot have orgasms can now have a device implanted in their
spines that will trigger the sensation for them. Clinical trials of the
"orgasmatron" have begun in the US, with the approval of the Food and Drug
The device was the focus of massive media attention two years ago, after New
Scientist broke the news of its existence and used the term orgasmatron to
But despite all the coverage, few people are volunteering for the trial. "I
thought people would be beating my door down to become part of the trial,"
says Stuart Meloy, the surgeon who patented the treatment. "But so far I am
struggling to find people."
That does not surprise some experts, who think an implant is too radical a
treatment for sexual problems. "Why would you do it invasively if you can do
it with a vibrator?" asks Marca Sipski of the University of Miami, who
studies sexual function in women with spinal cord injuries.
Only one woman has completed the first stage of the trial, and one other is
now being signed up. Meloy hopes to find eight more to complete the first
stage of the study, in which wires connected to a battery pack are inserted
through the skin and into the woman's spinal cord.
The procedure is no riskier than an epidural, Meloy says. But epidurals can
cause complications such as backache in up to a fifth of women. In the
second stage, a self-contained device resembling a pacemaker will be
implanted beneath the skin, switched on and off with a remote control.
Meloy, a pain specialist at Piedmont Anesthesia and Pain Consultants in
Winston-Salem, North Carolina, stumbled on the idea while performing a
routine pain-relief operation on a woman. During this procedure, two
electrodes are inserted in the patient's spine and tiny pulses of
electricity are applied.
Patients are kept conscious throughout the operation so that they can say
when they feel less pain. During one such operation, the patient began
exclaiming emphatically. When Meloy asked what was up, she said, "You're
going to have to teach my husband to do that."
This effect was already familiar to many surgeons performing such
operations, but Meloy patented the idea of using it to treat sexual
dysfunction. He tried to sell his idea to a company called Medtronic, but
when the company lost interest he decided to go it alone. He expects a full
implant to cost around $13,000.
In October, he implanted wires in a married woman who responded to his call
for volunteers in the local media. "When the device was switched on, the
patient reported being almost instantly aroused. She described it as 'really
excellent foreplay'," says Meloy.
The woman, who had not had an orgasm for four years, wore the device for
nine days and had sex with her husband on seven occasions. Meloy says she
had an orgasm every time. "She even told me she had the first multiple
orgasm of her life using the device," he says.
But Sipski thinks that as long as the required nerves in the body are
intact, using a vibrator should work just as well. "My research shows that
orgasm is a purely reflex response. Even the sensation associated with
orgasm does not require the brain. Women with complete injuries to the spine
can still experience orgasm."
Paula Hall, a sex therapist with the UK counselling service Relate, says
that most cases of sexual dysfunction are caused by psychological factors.
"Lack of self-awareness and not experimenting enough are the most common
reasons," she says. "In situations where all else has failed, some people
might consider surgery, but I don't think having an operation is going to
But Meloy is confident that it will. "I don't see it any differently from
procedures such as breast implants," he says.
Return to news story
© Copyright Reed Business Information Ltd.
FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available to advance understanding of ecological,
political, human rights, economic, democracy, scientific, moral, ethical,
and social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in section 107 of the
US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this
material is distributed without profit to those who have expressed a prior
general interest in receiving similar information for research and
educational purposes. For more information go to:
If you wish to use
copyrighted material for purposes of your own that go beyond 'fair use', you
must obtain permission from the copyright owner.