Opening up about this issue, a woman who used the "Thermiva" device from ThermiGen to treat her urinary incontinence said, "I was in so much pain. went to my OBGyn and she then informed me that I had bruising and she looked on the FDA website and told me that the product is not approved from FDA".
"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. "We are deeply concerned women are being harmed", Gottlieb said.
The FDA has requested that the manufacturers address the concerns within 30 days.
The cases were linked to energy-based devices, such as laser and ultrasound equipment, that were approved to treat conditions like removing genital warts. But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for "vaginal rejuvenation".
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".
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When pressed on why the program was being cancelled, MacLeod responded only that it was not going to be sustainable. Paul Knoll receives disability benefits and lives with his sister Helen Ries, who is his primary supporter.
"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said. The FDA also encourages women suffering from vaginal or sexual dysfunction problems to discuss their symptoms and potential treatments with their health care provider. "These products have serious risks and don't have adequate evidence to support their use for these purposes".
The FDA has warned seven companies that are promoting their devices for these procedures, and issued a general alert for patients and doctors. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain. Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said the laser technology held promise but more study was needed to understand the safety as well as which patients the devices might help.
Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to "vaginal rejuvenation" devices, ' according to the agency.