If you are one of millions of women who suffer from urinary incontinence, vaginal dryness, itching, and loosening you may be considering having a vaginal rejuvenation procedure. You may have seen these types of procedures advertised online or in a magazine, or you may have heard about them from a friend. But what you probably haven’t heard is that the devices used in these procedures have been called out for some serious injuries. Women who suffered serious injury should consider speaking with a vaginal rejuvenation surgery attorney to learn about their rights.
The FDA Has Received Injury Reports
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Some women’s health physicians are recommending that women demand the science behind new procedures before having them done, and others are telling women to avoid unproven treatments that may not even be as effective as approved and proven treatments that are currently on the market. The FDA is telling women that its received complaints and injury reports and to avoid having vaginal procedures performed using these devices until they have been proven safe and approved by the government agency.
Devices included on the FDA watchlist:
- DiVa Laser Vaginal Therapy
- MonaLisa Touch
- Ultra Femme 360
- Venus Fiore
The FDA sent It Has Come to Our Attention letters to the makers of these devices, including Alma Lasers, BLT Industries, Cynosure, InMode, Sciton, ThermiGen, and Venus Concept. These letters warned the manufacturers against overstating the health benefits of their devices and requested they prove the devices have been cleared for vaginal rejuvenation procedures.
Device Makers have 30 Days to Respond to FDA Warnings
Cynosure, maker of the MonaLisa Touch and the Vitalia probes, said after receiving the FDA letter that it will halt the distribution of Vitalia until it meets the FDA requirements. The company said it will work with the FDA on the issues surrounding the MonaLisa Touch but will not be pulling it from the market.
In a statement issued from Dr. Scott Gottlieb, Commissioner of the FDA, the agency wrote how these devices destroy and reshape vaginal tissue and about its concern that women are suffering harm. According to the statement, women reported suffering pain during sex after the procedure, as well as chronic pain, and vaginal burns and scars. The government watchdog agency gave the manufacturers 30 days to respond to the letters.
We Can Help
We are filing lawsuits on behalf of women who suffered burns, pain and scarring due to vaginal rejuvenation procedures performed with one of these unregulated devices. These lawsuits question why these device manufacturers didn’t warn women of the risks and dangers that may be associated with their devices, and why they advertise and market these devices as safe and effective treatments when they have yet to prove their safety and efficacy to the FDA.
If you or a woman you love suffered injury from a device used during a vaginal rejuvenation procedure, contact us today. We have been fighting for the rights of patients who suffer injury from devices and drugs that were advertised as safe and effective, and we will fight for you. Contact us now to learn more about these devices, your rights, and whether you are entitled to seek significant compensation for your vaginal rejuvenation injuries.