Monday October 22, 2018

“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
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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.

Also Read: Newly Developed Tool to Battle HIV in Women

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)

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First Self-Assisted Hearing Aid Approved by The FDA

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with a professional fitting of the same device

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An 85-year-old Nepalese man is seen fitted with a hearing aid, in Kathmandu, Nepal, April 12, 2017. VOA

The US Food and Drug Administration (FDA) on Friday allowed the marketing of a new hearing aid device that can amplify sounds for individuals 18 years or older with perceived mild to moderate hearing loss.

It is the first hearing aid approved by the agency that enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider, Xinhua news agency reported.

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Hearing loss, permanent or temporary, can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid, according to FDA.

Air conduction hearing aids can capture sound vibrations through one or more microphones and the signal is processed, amplified, and played back through an earphone placed in the ear canal.

FDA
A hearing aid (representative Image). Wikimedia

Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

Also Read: Eat Right Amount of Good Fat to Stay Healthy

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit. (IANS)