US Food and Drug Administration warns against vaginal rejuvenation devices

US Food and Drug Administration warns against vaginal rejuvenation devices

The FDA said "vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures meant to treat vaginal symptoms and/or conditions including, but not limited to: vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; and decreased sexual sensation".

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.

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).

We've recently become aware of a growing number of manufacturers marketing "vaginal rejuvenation" devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function.

The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta.

The FDA warned against "vaginal rejuventation" treatments.

Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment.

'Game of Thrones' castle can be yours -- but bundle up
In " Game of Thrones ", the castle served as the childhood home of Catelyn Stark, the matriarch of the infamous Stark family. According to the listing on Maison Real Estate's website, the building has no heating system.

Police ID suspect in Houston cardiologist's murder
Bush's doctors last month as Pappas, the son of a woman who died while the doctor was operating on her more than 20 years ago. Authorities on Wednesday, Aug. 1, 2018, identified a man who they believe gunned down one of former President George H.W.

Nicaragua’s president Ortega quizzed on country’s deadly crisis
The Nicaraguan protesters are demanding democratic reforms after years of fraudulent elections and repression of opposition parties and independent media, the White House said.

"We're deeply concerned women are being harmed by these procedures", he added.

"The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain", the FDA stressed.

The seven companies called out by the FDA are: BTL Industries, Inc; Cynosure, Inc.; Alma Lasers; Sciton, Inc.; Thermigen, Inc.; BTL Aesthetics; and Inmode MD Ltd. Their notifications express concerns over the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures". "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib said. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures.

The FDA has requested that the manufacturers address the concerns within 30 days.

The new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful. Some of the companies such as Cynosure that is owned by Hologic Inc. state that they have based their treatments on science.

BTL and Cynosure, a division of Hologic, said they were reviewing the warning letters. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".

Related Articles