FDA warns companies about 'deceptive' vaginal rejuvenation claim

Share
FDA warns companies about 'deceptive' vaginal rejuvenation claim

The procedures, which use lasers and other energy-based devices to remove or reshape vaginal tissue, claim to treat conditions and symptoms related to menopause, urinary incontinence or sexual function.

The laser devices used in vaginal rejuvenation are cleared for some medical uses.

"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously", Jane Mazur, a representative for Hologic, Inc., said in a statement.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said in a statement.

But in a statement released Monday, the FDA said it's identified numerous cases of vaginal burns or scarring tied to vaginal rejuvenation, as well as post-procedural pain during sexual intercourse or recurring or chronic pain.

The seven device makers notified by FDA are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

The FDA clarifies that they have approved laser and energy-based devices for use to treat serious conditions such as genital warts.

Experts say the "therapies", offered by some private clinics in the United Kingdom and the U.S., pose a serious risk of burns, scarring and recurring pain.

The safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" has not been established. The company is one of several that was issued a letter from the agency prompting device manufacturers to respond within 30 days or face potential enforcement actions.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification".

Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain. We will keep the public informed if significant new information becomes available.

The FDA is encouraging women to stop using these devices and report any issues to the FDA's adverse event reporting program, called MedWatch. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Share

Advertisement

Related Posts

Trump to Keep Kelly as His Chief of Staff Through 2020
The longest-serving chief of staff is John Steelman, who spent six years working for Harry Truman. Trump congratulated John Kelly in a tweet that includes a photo of the two men smiling wide.

Pope Francis changes Catholic teaching on death penalty
The Catechism of the Church, which sums up the teachings, had previously stated that the death penalty could be used in some cases.

Tax Free Weekend in Missouri Set for August 3-5
Target for one has had a lot of traffic and have been restocking regularly due to tax free weekend. She adds taxes can be avoided on layaway items, as long as transactions take place this weekend.

Google Clock Gets Spotify Integration for Custom Alarms
Perhaps Google wanted to test it with Spotify users before it invested the man-hours needed to include its own streaming services. Once the alarm goes off and you switch it off, you'll supposedly be able to continue listening to Spotify .

Loans to get costlier as RBI hikes repo rate again
This has now gone down to 0.63%, but it's still higher than it was before the rate increased at the end of 2017. Bank staff believe this weakness was temporary and expect the economy to expand by 0.4% in the second quarter.

Trump Says Jeff Sessions Should 'Stop This Rigged Witch Hunt Right Now'
Trump asserted that neither he nor his campaign had any collusion with the Russians, and all the allegations were a total hoax. No. 3 Senate GOP leader John Thune of South Dakota said, "The idea that they should truncate it doesn't make sense to me".

This week’s Fortnite update is all about explosives
The servers are expected to be down around 1:00 AM PT/4:00 AM ET tomorrow, so expect to see these missiles very soon. And is described like this: "Husks don't stand a chance against this newest addition to the Flintlock Weapon set".

Chipotle shuts Ohio restaurant after reports of illness
Business Insider reported late-Monday that more than 170 people said they fell ill after eating at a restaurant in OH . The local health department found food cooking violations at this location before this story broke.

States suing Trump administration, company over 3D-printed guns
In the United States, it is now illegal to own or make a wholly, plastic gun of any kind - including those made on a 3D printer . By Sunday, 1,000 people had already downloaded 3D plans for AR-15 semi-automatic assault rifles.

'Infowars' host Alex Jones doesn't attend hearing in Sandy Hook lawsuit
One suggestion to ban Jones' podcast from the service has received almost 2,000 votes on Spotify's Community submissions page. In this April 17, 2017, file photo, " Infowars " host Alex Jones arrives at the Travis County Courthouse in Austin, Texas.

© 2015 ExpressNewsline. All Rights reserved.