‘Vaginal Rejuvenation’ Devices Have Serious Side Effects, Unproven Claims: FDA

The federal agency has sternly cautioned against the use of these treatments, warning doctors not to resort to using laser or other energy therapies to treat sexual dysfunction or other issues affecting women following childbirth or menopause.

"We requested that the manufacturers address our concerns within 30 days", said Gottlieb.

The FDA noted in a safety alert issued Monday that vaginal "rejuvenation" often is used to describe nonsurgical procedures meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during intercourse or urination. "The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

But their use to treat vaginal dryness, itching and laxity, the FDA said, has not been approved. 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.

The FDA said these unapproved therapies - often radiofrequency or laser devices cleared for condylomas, abnormal or pre-cancerous tissue, and other conditions - could lead to serious side effects, including vaginal scarring and burns, pain during sex, and chronic pain.

"But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation, ' " he added. The notified manufacturers include: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen.

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

Priyanka Chopra and Nick Jonas are Engaged!
The filmmaker wrote a cryptic post very heavily hinting that the star is going to tie the knot soon with Nick . Pictures of the actor enjoying the event and interacting with Nick's family went viral on the internet.

Facebook finds 'sophisticated' efforts to disrupt elections
Among the new accounts were one called " Resisters " which promoted a fake anti-right wing protest in August in Washington D.C. The participants include the " Aztlan Warriors ", "Black Elevation", "Mindful Being", and " Resisters " pages.

International News Mourinho says United in trouble 7 hours ago
Darmian played just 8 EPL games last season, providing back-up to Manchester United's regular full-backs, Ashley Young and Valencia.

Jane G. Mazur, a spokeswoman for Hologic Inc. whose subsidiary sells the MonaLisa Touch, said they were reviewing the FDA notice.

The statement issued by the FDA says, "We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures". In addition, there are many reports of women being injured by these procedures.

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".

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".

"These products have serious risks and don't have adequate evidence to support their use for these purposes", said Dr. Scott Gottlieb, the FDA commissioner.

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".

(Copyright © 2015. All Rights Reserved.)
 
Recommended

Investigators gave up search for missing Flight MH370 months ago
No irregularities were found in the on-board cargo, which included items like lithium batteries and about 2,500 kgs of mangosteen. To date, the only confirmed traces of the Boeing 777 aircraft have been three wing fragments washed up on Indian Ocean coasts.

Wedding bells heard for Nick Jonas & Priyanka Chopra Trending
Katrina might be considered as possible replacement for Priyanka in " Bharat ", sources add. Getting engaged after a few months of dating seems to be popular in Hollywood lately.

Egypt zoo accused of painting donkey to look like a zebra
Mohamed Sultan, the zoo's director, told a local radio station that none of the animals in the facility are fraudulent. In 2009, a zoo in Gaza did the same thing, saying that it could not procure real zebras due to an Israeli blockade.

One Israeli dead, two wounded in West Bank knife attack
Sources confirmed that another artillery shell also coincided with a Hamas observatory outpost east of Gaza City. The kites have caused hundreds of fires inside Israel in recent months, according to Israeli officials.

Trump denies knowing of 2016 Trump Tower meeting with Russians
Rivera said Cohen was somewhat of a "consigliere" to Trump, in that he was the "one key person we tell all of our life story to". Trump Jr responded "I love it" when first offered the political " dirt " on Clinton, the Democratic presidential nominee.

North Korea possibly constructing new intercontinental ballistic missiles
And 38 North is also skeptical concerning reports of "secret uranium processing facilities" that have emerged over the last month. Trump later suspended annual military drills with South Korea which North Korea had long called an invasion rehearsal.

Trump Threatens US Government Shutdown over Immigration
Trump is noting that Italian voters got "tired" of their country's immigration policies. Government funding expires midnight September 30.

Expected star witness may not testify in Trump ex-aide Manafort's trial
The comments were the first volley in the bank fraud and tax evasion trial. "It's not the American way", the judge said. Asonye told Ellis Wednesday afternoon that prosecutors could rest their case as early as next week.

Vettel fastest in Hungary but Mercedes in a spin
Vettel said he was not concerned, either by his championship position or by comparisons with past year . "Absolutely not. In lap number 10, the advantage of Hamilton grew to 4.4 seconds, while in lap 14, Raikonnen stopped to change tyres.

Facebook finally suspends Alex Jones and Infowars for hate speech
Within Facebook, the free-speech issues raised by Infowars and Jones have become an especially contentious topic. YouTube's "strike" against Infowars means it is banned from live-streaming on the platform for 90 days.

Manchester United confirms that Valencia has become permanent captain
Anthony Martial can be "one of the best players in the world", according to Manchester United team-mate Ander Herrera . Chelsea FC have so far only made one signing this summer after having brought in Jorginho from Napoli last weekend.

Injury-hit Manchester United 'in trouble' for new campaign, says Jose Mourinho
They deserve the best teams and invest to bring the best clubs to the US. "But you don't know what goes on behind closed doors". And Mourinho is angry at United's failure to deliver all the transfer targets he identified at the start of the summer.

The Manafort trial: Opening statements begin
If the judge rules in their favor, prosecutors could present evidence that delves deeper into Manafort's Russian connections. The trial is expected to drag on for at least three weeks, with jury selection for the case beginning on Tuesday.

Sky's Thomas poised for victory as record-chasing Froome breaks
With that in mind, Thomas even pushed for a four-second time bonus allocated to the rider taking third place in the stage. Froome has been a repeated target of fans in this Tour after he was cleared of doping five days before the race began.

World Hepatitis day observed at Sindh Institute of Urology and Transplantation
Treatment is required for only those who have an active infection, and has to be taken for long periods, often years. The alarming report showed that among people living in north India, hepatitis A and B is also prevalent.


More News

News
More News