Tuesday June 25, 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 Approves Device to Treat Heart Failure Patients

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics

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The US Food and Drug Administration has given approval for a new device that would help treat patients with life-threatening heart failure, and address an unmet need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.

After the device is implanted, a physician tests and programmes the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The device would be beneficial for patients not suited to treatment with other heart failure devices such as cardiac resynchronisation therapy to restore a normal timing pattern of the heartbeat, the US FDA noted in a statement.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, Director at FDA’s Centre for Devices and Radiological Health.

Photo Credit: www.medscape.com

“The FDA recognised the unmet need for these patients and worked with the manufacturer…to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman added.

For the study, the US FDA evaluated data from two clinical trials with a total of 389 patients with moderate-to-severe heart failure.

All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant.

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The Optimizer Smart system improves quality of life and functional status of certain heart failure patients.

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics. (IANS)