“Orgasmatron” implant experiment – legitimate or dubious?

Fri, 28 Nov 2003

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 and discomfort outweigh the unproven benefits for what is, at best, a controversial, possibly spurious diagnosis.

http://www.newscientist.com/news/news.jsp?id=ns99994419

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 Administration.

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 describe it.

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.

Remote control

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.

“Excellent foreplay”

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 catch on.”

But Meloy is confident that it will. “I don’t see it any differently from procedures such as breast implants,” he says.

David Cohen

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