FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

The Food and Drug Administration (FDA) has issued an alert to healthcare providers concerning the use of energy-based devices for vaginal "rejuvenation", a term used to describe non-surgical procedures meant to treat vaginal laxity, atrophy, dryness, or itching; pain during sexual intercourse or urination; or for decreased sexual sensation.

The administration said some of the procedures use lasers or "energy-based devices" to "destroy or reshape vaginal tissue".

"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY.

To view the full article, register now.

Russian Federation is continuing efforts to interfere in USA politics: intel chief
Stewart said when he made his predictions, he was asked about who he thought Russian Federation wanted to win the election. Mr Coats said: "Our focus here today is simply to tell the American people we acknowledge the threat".

The US Food and Drug Administration (FDA) has warned against the use of devices that promise "vaginal rejuvenation", stating that it can cause serious effects. But the agency has not cleared the devices for symptoms related to menopause, urinary incontinence or sexual function.

According to CNBC, the American College of Obstetricians and Gynecologists recommends "doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures".

But the FDA says these companies have not gone through the correct approval process to show that the treatments work as advertised, or even that they are safe.

Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a risky procedure with no proven benefit". "We are deeply concerned women are being harmed", said FDA commissioner Dr Scott Gottlieb in a statement. Their notifications express concerns over the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures".

A Year Of California Wildfires
Officials say 20 people who had been reporting missing in California's devastating wildfires are now accounted for. Meanwhile, 32,000 residents are still evacuated from the fires and more than 1,000 homes have been destroyed.

"In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain", the agency said.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.

The FDA will closely monitor reports of problems associated with "vaginal rejuvenation" procedures, and will keep the public informed, Gottlieb said.

Hologic, Inc., which owns Cynosure, wrote in an email that they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".

Zimbabwe elections on 'unlevel playing field,' say European Union observers
Police patrol outside the Zimbabwe Electoral Commission offices in Harare, Zimbabwe . A presidential candidate needs more than 50% of the vote to win outright.

The companies involved say they are reviewing the warning letters from the FDA, which advises them to stop promoting the treatments.

Related news:

Hot News

isis-killer-beheading-video-story-top Whoops: UK Retailer Reveals New DJI Mavic 2 Before Official Release
Aug 03, 2018 - 11:12
We'll have to wait and see, but if all of this comes to fruition there are some big product launches on the way from DJI. In the catalogue, there is no mention of the recording capabilities, though we would not rule out 4K recording features.

isis-killer-beheading-video-story-top Alisson Becker feeling at home at Liverpool as Premier League season nears
Aug 03, 2018 - 11:08
Klopp confirmed over a week ago that this is likely to come during the preseason friendly with Napoli in Dublin on Saturday. It is an improved situation that these players don't use us and then go.

isis-killer-beheading-video-story-top Trump received letter from North Korea's Kim on 1 August: White House
Aug 03, 2018 - 10:48
Another method of identification was through chest x-rays that were on file for those who served in the Korean War, McKeague said. Army soldiers who fought in the November, 1950 Battle of Chosin Reservoir - 1,024 Americans are still missing from that battle.

isis-killer-beheading-video-story-top Judge Grants Temporary Restraining Order Against Making 3-D Guns
Aug 03, 2018 - 10:46
The Supreme Court has yet to tackle the case, but lower courts previously struck down the freedom of speech argument. On Tuesday, before the court decision , the States Department Spokeswoman said, it'll be a hot topic.

isis-killer-beheading-video-story-top Florida firefighters report for duty on front lines of California fires
Aug 03, 2018 - 10:06
Cal Fire said that "steep terrain, erratic winds, and previously unburned fuels are contributing to spot fire potential". The fire, which is almost twice the size of Sacramento, was only 35 per cent contained after more than a week.

Donald Trump mulls imposing 25% tariffs on Chinese goods
Aug 02, 2018 - 22:25
When the list was initially published last month, the planned levy was just 10 per cent. China has already complained to the World Trade Organization about the 10% tariff plan.

Trump thanks Kim for handing over remains of war dead
Aug 02, 2018 - 22:20
The ambassador added a good starting point would be a North Korea list of nuclear facilities. General Assembly meeting when world leaders gather in New York City.

isis-killer-beheading-video-story-top Chelsea manager Sarri rules off exit for Blues' striker
Aug 02, 2018 - 22:04
Real Madrid , Barcelona , Villarreal, Juventus, Bayern Munich and Monaco were all keen on signing a player who scored 21 goals in 30 games across various age groups last season.

isis-killer-beheading-video-story-top Apple is first public company worth $1 trillion
Aug 02, 2018 - 20:07
Amazon's market cap stands at around $877 million, while Alphabet's is $851 million and Microsoft is worth about $822 million. Companies typically do so when they consider their stock to be undervalued-or to return funding to investors.

isis-killer-beheading-video-story-top India's Smriti Mandhana scores joint-fastest fifty in women's T20
Aug 02, 2018 - 11:11
Indian T20I vice-captain Smriti Mandhana has been in fine form in the ongoing Kia Women's Cricket Super League T20 tournament. With today's win, Western Storm moved onto nine points, going past their opponents with an extra point under their belt.

isis-killer-beheading-video-story-top Three die in plane crash in Greenville
Aug 02, 2018 - 11:11
A spokesperson with the Piscataquis County Sheriff referred all questions to the FAA, which is now conducting an investigation. Crandall said when he arrived at the scene the plane was in a field, and first responders found the bodies in the fuselage.

isis-killer-beheading-video-story-top Samsung Galaxy J6 price slashed in India
Aug 02, 2018 - 10:48
It has a resolution of 2500 x 1600 and keeps Samsung's favorite Super AMOLED technology, the same as found on last year's model. Revenue in Samsung's mobile division declined 22 percent in the quarter to 22.67 trillion won ($20.2 billion).

USA considers higher tariffs on $200 billion in Chinese imports
Aug 02, 2018 - 10:43
A first round of tariffs came into effect on 6 July, when the USA imposed 25% taxes on $34bn of Chinese imports. A hearing on the levies is scheduled for August 20-23.

isis-killer-beheading-video-story-top Vehicle bomb explodes near Army checkpoint, 10 killed, 5 wounded
Aug 02, 2018 - 09:44
Philippine military officials say a bomb explosion killed a soldier, five militiamen and four villagers amid threats of bombings in a southern province.

isis-killer-beheading-video-story-top Federal judge blocks release of plans for 3D-printed guns
Aug 02, 2018 - 09:17
Gottlieb says the entire thing is political, that if some Washington leaders had their way they would prohibit all guns. His goal is to keep publishing blueprints until every gun design on Earth is available to anyone online.