FDA warns about vaginal 'rejuvenation' device claims
Aug 03, 2018, 11:12
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 are deeply concerned women are being harmed", Gottlieb said.
The FDA also noted in a safety alert that vaginal rejuvenation is often used to describe nonsurgical procedures that are meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during urination, among others.
USA regulator the FDA says it will take action if deceptive marketing of the "dangerous procedure with no proven benefit" continues.
Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for "vaginal rejuvenation" [news release]. Needless to say that the FDA has yet to review, let alone recommend, these 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 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.
Understand that the FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function. But the FDA noted the devices haven't been evaluated or approved for vaginal rejuvenation.
Several manufacturers - Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen - were put on notice, and their device claims will be monitoring.
One such company that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch. "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib 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".
However, these devices have not been approved for so-called vaginal rejuvenation. "But these reports indicate these procedures can cause serious harm", the FDA said. The administration says if the companies fail to address the issue within the notice period, it will take "potential enforcement actions". Some of the companies such as Cynosure that is owned by Hologic Inc. state that they have based their treatments on science.
The Pro version has a 1-inch CMOS sensor Hasselblad camera , while the Zoom version has a 2x zoom lens and Dolly Zoom effect . A spokesman for DJI said: "This pre-printed catalogue was scheduled before we postponed our "See the Bigger Picture" event".
Facebook also said it has reported its findings to law enforcement and will continue to search for other fake accounts. The most followed Facebook Pages were " Aztlan Warriors ", "Black Elevation", "Mindful Being", and " Resisters ".
To date, the fires have burned over 320,000 acres and damaged or destroyed over 1,600 homes and other structures. Meanwhile, 32,000 residents are still evacuated from the fires and more than 1,000 homes have been destroyed.
Individuals living with a disability were receiving an additional $6,000 per year. "I'm disappointed and upset", Knoll said. That government had targeted involving 1,000 participants in the Thunder Bay area, with a total of 4,000 across Ontario.
Defense Secretary Jim Mattis last week also cautioned that the remains might not all be those of US service members. Experts say the North likely wants a declaration of the end of the Korean War as part of US security assurances.
Officials are lifting more evacuations across Shasta County as firefighters gain containment on a wildfire burning in the region. The fire is progressing into the town of Lewiston, Cal Fire spokesman Gabe Lauderdale said in a press video Wednesday morning.
In an interview with McMurphy, Courtney reportedly said she and Shelley regularly talked about Zach's abuse in 2015. Zach Smith was sacked last week after an OH court granted a domestic violence protective order to Courtney Smith .
The report added that details of the Priyanka's role are not confirmed as of now but she will be the leading lady. Her first global stint came in 2012 when she launched her worldwide single "In My City" featuring will.i.am.
But the recovery might not have happened if Jobs hadn't evolved into a more mature leader after his exit from the company in 1985. Just months away from his death, Jobs officially handed off the CEO reins to Cook in August 2011.
In that time, its focus has shifted away from collusion, to looking for evidence that Trump and his team obstructed justice. In a series of tweets, Trump called a "TOTAL HOAX " the idea his campaign worked with Moscow, which Mueller is examining.
Tesla also said it's working on a new version of its Autopilot semi-autonomous software that will have greater safety features. The company laid off nine percent of its workforce in the second quarter as it attempted to become profitable.
Russia Deploys Military Police on Golan Heights
Israel has called for Iranian-backed forces to withdraw from Syria, appealing to Russian Federation to enforce their exit. Israeli troops were on "high alert and readiness" following the strike.