Thursday November 21, 2019

“Vaginal Rejuvenation” is Dangerous, Says The FDA

Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options

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The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. Pixabay

The US Food and Drug Administration (FDA) has slammed all those devices being marketed for medical procedures like vaginal rejuvenation as “egregious” and causing “harm”, a statement said.

The regulatory body has found that a growing number of manufacturers were marketing such devices to women, claiming to treat conditions and symptoms related to menopause, urinary incontinence or sexual malfunction.

The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue.

However, “these products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed”, said FDA Commissioner Scott Gottlieb.

The FDA found that the use of these devices caused numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.

Countering an earlier clearance on laser and energy-based devices for treating serious conditions, including pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts), the FDA said at that time its safety and effectiveness had not been evaluated or confirmed for vaginal rejuvenation, the statement said.

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The FDA found that the use of these devices caused numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain. Pixabay

Moreover, these devices are also being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, the regulatory body found.

“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said.

“Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared,” Gottlieb said.

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The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.

“Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options,” Gottlieb noted. (IANS)

Next Story

FDA Wants Women Getting Breast Implants to Receive Stronger Warnings about Possible Risks and Complications

The recommendations are the agency's latest attempt to manage safety issues with the implants

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FDA, Women, Breast Implants
FILE - A photo shows the U.S. Food & Drug Administration (FDA) campus in Silver Spring, Maryland. VOA

U.S. health officials want women getting breast implants to receive stronger warnings about the possible risks and complications. FDA.

The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients for implants.

The recommendations are the agency’s latest attempt to manage safety issues with the implants.

FDA, Women, Breast Implants
The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients. Pixabay

In recent years, the FDA and regulators elsewhere have grappled with a link between a rare cancer and a type of textured implant, some of which have been recalled. Separately, the agency has received thousands of reports of health problems that some women attribute to the implants, including arthritis, fatigue and muscle pain.

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The FDA will take public comment on the recommendations before adopting them. (VOA)