Vaginal Rejuvenation Procedures
Several manufacturers have been marketing devices to be used for vaginal rejuvenation procedures, even though the FDA originally approved them to treat serious conditions like cancer and genital warts. Deceptive marketing like this can prevent patients from getting the correct treatment they need.
Women have reported serious injuries following these procedures. Unfortunately, not enough doctors and patients are aware that these devices are unsafe for vaginal rejuvenation procedures.
Case Quick Facts
On July 30, 2018, the FDA warned several manufacturers to stop marketing their devices for vaginal rejuvenation procedures. The FDA claims these devices were never approved for this kind of procedure, but rather for cancer and genital warts. Some of the devices were approved for dermatology procedures, like wrinkle treatment.
The FDA claims these are “dangerous and deceptive treatments.” While a product can be used off-label by a doctor, they cannot be promoted off-label.
There have been 14 adverse events reported following vaginal rejuvenation procedures. While the extent of side effects is unknown, reported injuries include:
- Vaginal burns
- Chronic pain
- Numbness or less of sensation
The FDA sent out warning letters to the following companies:
- Alma Lasers
- BTL Aesthetics
- BTL Industries
These warning letters requested the clearance or approval number for the product they are marketing. Since the FDA’s statement was released, some manufacturers removed the product from their website. BTL Industries, Inc. removed the Exilis Ultra 360 product from its website after the FDA called them out for using deceptive promotional content.
It isn’t right that these manufacturers illegally and deceptively marketed these products to be used for something they were not approved to treat. If you or a loved one experienced a serious injury following a vaginal rejuvenation procedure, contact GoldenbergLaw. We have the experience and success to fight on your behalf.Do I Qualify?
Studies & Reports
Fractional laser treatment of vulvovaginal atrophy and U.S. Food and Drug Administration clearance. ACOG. American College of Obstetricians and Gynecologists. Obstet Gynecol 2016.
This position statement affirms that many lasers used for vaginal rejuvenation procedures were not approved by the FDA, and further warns OB-GYN’s to be cautious in adopting new approaches and procedures on the basis of marketing.
Studies & Reports
Vaginal “rejuvenation” and cosmetic vaginal procedures. ACOG Committee Opinion No. 378. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;110:737–8.
This article from a medical journal suggests that doctors should inform patients about the lack of data surrounding the efficacy of vaginal rejuvenation procedures.
Why Choose GoldenbergLaw?
When it comes to handling a vaginal rejuvenation procedure lawsuit, our team should be the first you call. GoldenbergLaw is made up of a team of individuals who care about our clients, and want to get them the compensation they deserve. If you have been affected negatively by a vaginal rejuvenation procedure, contact us and get a free consultation.
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