FDA Approves Its 1st Female Sex Aid

The Food and Drug Administration on Wednesday approved a device designed to help women achieve sexual satisfaction, marking the first time that the federal government has licensed an aid for women with sexual dysfunction.

In recent years, the market has seen a spate of products--including the blockbuster drug Viagra--aimed at enhancing sexual performance, but the emphasis has been primarily on helping men.

The Eros device, made by UroMetrics Inc. of St. Paul, Minn., uses the same basic principle as the drug Viagra to promote sexual arousal--stimulating blood flow to the genital area, in this case to the clitoris.

“It does not help every woman,” stressed Dr. Diane Mitchell, the FDA gynecologist who reviewed the device. In particular, it may not be suitable for women whose sexual dysfunction is psychological in origin.

But the small, hand-held product “may really be of benefit to some,” Mitchell said.

Although statistics are scant and the reasons for female sexual disorders vary, an estimated 43% of women are believed to experience some sexual problems.

Until now, estrogen therapy and vaginal lubricants--to ease dryness--were the only products available to women experiencing sexual dysfunction. Viagra and other drugs are being tested in women--and many women are believed to be using Viagra “off label”--but its effectiveness for them is unclear.

At a cost of $359, the Eros product will be available immediately but, at least for now, only by prescription, said Marlene Wesen, a UroMetrics spokeswoman.

Wesen said she believes that the device will be covered by insurance “because similar devices for men are covered and we assume that insurance companies will not distinguish between genders.”

A prescription will be needed to obtain the product, not because of side effects or because the FDA thinks it may be dangerous, but because it should be used only with a physician’s guidance, Mitchell said. “We want it to reach the right patient population,” she said, in particular, women whose problems are physiological in nature.

However, “once it is out on the market for a while and better understood in a widespread population, I think going over the counter would be worth considering,” she said.

Mitchell noted that “this is really a multifaceted disease” with “lots of reasons why women experience problems.”

She acknowledged that it might take some doing for women to be forthcoming with their doctors about sexual difficulties, making it “an easily overlooked problem.”

As a former practicing gynecologist, she recalled: “You sometimes have to ask them fairly vague questions, like, ‘Are you having any problems with your sex lives?’ ” to encourage dialogue.

Menopause, surgery or injury may be factors in some cases of sexual dysfunction. In others, the cause--for men as well as women--may be emotional, some medical experts said. Clinical researchers have had success in treating some patients with low sexual libido using a combination of education and masturbation exercises.

And several pharmaceutical companies are working on new drugs to enhance sexual arousal for women and men.

UroMetrics, which specializes in products for sexual health, has two devices on the market to help men with sexual dysfunction. The company developed Eros after “the light came on here, and we realized--hey, there’s nothing out there for women,” Wesen said.

The device consists of a small soft plastic cup that is placed over the clitoris. A tube attaches it to a hand-held vacuum.

Within minutes, the action draws blood to the area, engorging the clitoris, and aiding in sexual arousal.

The product was studied in 25 women, each of whom used it at home during six sexual encounters, according to the FDA. Fifteen of the women had been suffering from sexual arousal disorder and 10 had not.

Of the 15, all said that they experienced increased sensation. Seven of them said that they had more orgasms. Twelve reported “more satisfaction” and 11 more lubrication.

Four of the 10 women with normal sexual function said that they experienced more sensation. Four had more orgasms, while two experienced “more satisfaction” and three more lubrication.

The women reported no adverse side effects.

Wesen, of UroMetrics, said that two of the women whose sexual difficulties had seriously impaired their relationships “reported that their sex lives had improved so much that they were getting married.”