‘Vaginal rejuvenation’ laser treatments can cause burns and pain, FDA warns

The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday

The Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as "vaginal rejuvenation", saying they were risky and deceptive treatments.

"But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation, ' " he added.

"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 FDA said it was "deeply concerned" people were being injured with these procedures.

While these energy-based devices (radiofrequency or laser) have been approved for general gynecologic tool indications (i.e., destruction of abnormal or pre-cancerous cervical or vaginal tissue, condylomas), the Agency has become aware of some manufacturers marketing these devices for vaginal "rejuvenation" or vaginal cosmetic procedures.

"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.

The FDA said they issued warnings over "inappropriate marketing" to device manufacturers Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

According to Scott Gottlieb, many manufacturers have marketed their devices as being useful in "vaginal rejuvenation" (a procedure that usually destroys or reshapes the tissue).

Chipotle slumps nine percent after OH outlet linked to food poisoning complaints
In early morning trading, Chipotle's stock hovered around $436 a share, down about 6 percent from Monday's closing price . That news also surfaced through iwaspoisoned.com when 89 reports and 133 customers reported falling sick.

Watch Dwayne Johnson Surprise His Stunt Double With an Amazing Gift
Reed glanced around and spots a shiny new pickup truck with a big red bow attached to the hood, and became immediately emotional. As you can see, it's clear that Tanoai was pretty touched by his cousin's gift, and looked quite tearful when he hugged him.

Cristiano Ronaldo's Replacement Confirmed By Julen Lopetegui
Former Real Madrid star player Pedja Mijatovic has revealed he believes that Ronaldo's departure was down to his relationship with Perez.

If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand.

In particular, the FDA was concerned about laser treatments as they have been known to potentially cause "serious adverse events, including vaginal burns [and] scarring". However, a new warning from the Food and Drug Administration (FDA) has suggested women stay away from these procedures as they haven't yet been properly tested or approved by the FDA yet.

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 agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore RF Ablation System and other devices, telling them to stop promoting them for the rejuvenation procedure.

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

We've been focused on advancing new policies to improve our oversight of device safety.

The FDA urges anyone who suffered a complication linked to a vaginal "rejuvenation" treatment to report it through MedWatch.

Related news:

Hot News

Trump’s Tweets Today Are Especially Unhinged and Illuminating :: Politics :: Features :: Donald Trump
Aug 03, 2018 - 01:35
Trump attorneys say both sides have exchanged proposals for conditions for such a Trump interview. He used Mr Mueller of "creating the illusion of objectivity around his investigation".

isis-killer-beheading-video-story-top Spotify Removes Multiple Episodes Of Alex Jones' Podcast From Service
Aug 03, 2018 - 00:41
The parents have said Jones has engaged in a campaign of "false, cruel, and unsafe assertions", court filings showed. He has also promoted a theory that the 9/11 attacks on NY and Washington were staged by the government.

isis-killer-beheading-video-story-top OPEC Oil Production Hits 2018 High In July
Aug 02, 2018 - 23:32
Later in the week, the API and the EIA will report on U.S. crude oil stockpiles on Tuesday and Wednesday, respectively. Despite all the pipeline bottlenecks, the increase of rig counts is a negative factor for oil prices.

isis-killer-beheading-video-story-top McDonald’s coffee calamity: Pregnant woman served cleaning solution in her latte
Aug 02, 2018 - 23:14
Since she did not swallow any of the fluid, Douglas was ultimately fine and given the all-clear by a doctor, she said. Upon lodging a complaint she learnt from staff members that two cleaning lines were linked to the coffee machine.

isis-killer-beheading-video-story-top Trump celebrates Kelly's first full year as chief of staff
Aug 02, 2018 - 23:06
Kelly has told allies that he feels it his duty to serve even if he and the president differ on style and messaging. But it appears that the president is eager to end the rumors of Kelly's departure for good.

isis-killer-beheading-video-story-top Call of Duty: Black Ops 4 multiplayer beta teases Blackout Royale
Aug 02, 2018 - 23:00
PC players will have their own open beta which will take place from 6pm on Saturday, August 11 until Monday at 6pm, August 13. The company released a new trailer promoting the multiplayer beta which also included our first look at Blackout .

Disney Says That The Rehiring Of James Gunn Is Unlikely
Aug 02, 2018 - 22:46
Gunn's firing was approved by Disney's films division chief Alan Horn, with his boss Bob Iger weighing in on the final decision. This raises another question: will Pratt and his ragtag crew reprise their roles for Guardians of the Galaxy Vol. 3?

isis-killer-beheading-video-story-top Rangers Trade Diekman To Diamondbacks For 2 Prospects
Aug 02, 2018 - 22:41
The Marlins received minor league reliever Tommy Eveld in return for Ziegler, a right-hander with a sidewinding throwing motion. The 24-year-old Huang was a combined 6-2 with a 2.31 ERA in 29 games with Class A Visalia and Double-A Jackson this season.

isis-killer-beheading-video-story-top Trump administration to freeze fuel efficiency requirements
Aug 02, 2018 - 22:35
Cars drive past a California emissions testing site in Oceanside, California, U.S. on September 29, 2015. Apparently, this could save 1000 lives a year if fuel economy standards remain at 2020 levels.

isis-killer-beheading-video-story-top Honor Play to get GPU Turbo update in August
Aug 02, 2018 - 22:33
The phone, just like previous flagships from Honor, comes with some AI Features like Scene Detection, Portrait Mode, etc. It provides better gaming experience with options like screen recorder, bright mode, do not disturb and more.

isis-killer-beheading-video-story-top Fortnite Content Update V5.10 Adds Guided Missiles, New Limited Time Mode
Aug 02, 2018 - 22:15
The legendary guided missile launcher originally dealt 105 damage, while the epic did 110 damage. Available Wednesday, August 1 at 8:00 PM ET until Wednesday, August 8 at 8:00 PM ET.

New Report Sheds Light on Presidential Twitter Tirade Against Robert Mueller
Aug 02, 2018 - 22:00
He has repeatedly said Trump wants to interview with Mueller, while simultaneously casting doubt on the chances of it happening. Trump called Mueller's team of investigators " 17 Angry Democrats ", accusing them of bias in favor of the Democratic party.

isis-killer-beheading-video-story-top Mourinho confirms star midfielder will miss the start of the season
Aug 02, 2018 - 21:24
Smalling and Luke Shaw are doubtful for the game against Champions League winners Real. I think I can make the step now to play every week at Manchester United ".

Google plans censored version of search engine in China, says U.S
Aug 02, 2018 - 20:56
The (successful) refusal of Google staff to work for the USA military has proved that workers have a say in the company's future. China's top internet regulator, the Cyberspace Administration of China, has not commented on the reported plans.

isis-killer-beheading-video-story-top Death penalty is inadmissible in all cases, says Pope Francis
Aug 02, 2018 - 20:54
Pope Francis recently approved changes to the Catholic Church's catechism that forbids the death penalty in all circumstances. Francis has long railed against the death penalty , insisting it can never be justified, no matter how heinous the crime.