After giving birth, most women look forward to getting their bodies back to “normal”. This is especially true since a vaginal delivery can lead to such problems as vaginal laxity and dryness, sexual dysfunction, and stress incontinence.
Non-surgical vaginal rejuvenation is rapidly growing in popularity. Following the lead of numerous
celebrity endorsements and advertisements in popular magazines, tens of thousands of women are
choosing to use energy-based medical devices to achieve vaginal rejuvenation and for cosmetic
purposes. Now, the Federal Drug Administration is warning both patients and the health care community of the dangers of these products and procedures.
Alert from the Federal Drug Administration
Stating that the safety and effectiveness of these devices has not been established, the FDA warning
includes possible serious outcomes including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain. The FDA stresses that it has not approved any energy-based medical device for vaginal rejuvenation or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to urinary incontinence or sexual function. A May 2016 position statement issued by the American College of Obstetrics and Gynecologists urges physicians to be “wary of adopting new or innovative procedures on the basis of promotions and marketing”.
Types of Energy-Based Devices for Vaginal Rejuvenation
Energy-based devices for feminine rejuvenation first became available in 2008 in Europe. There are two main technologies utilized:
Radiofrequency (RF) Treatments: Emit electromagnetic waves to heat the tissue. Brand names include:
- ULTRA Femme 360
- Venus Fiore
- Protégé Intima
CO2 and Er:YAG (erbium: yttrium-aluminum-garnet) Lasers: Emit laser energy in the mid-infrared invisible light spectrum to heat the tissue. Brand names Include:
- MonaLisa Touch®
- CO2RE Intima
- Petit Lady
The complications which can occur from these products and procedures can mean that a new mother’s body may have more serious issues after the treatment than before the treatment. The FDA says the benefits of these devices for vaginal rejuvenation have not been proven, and it has reports of substantial injuries these devices have caused. Just because a procedure is non-surgical, does not mean that it is non-dangerous.
If you have been seriously injured by an energy-based device used for a vaginal rejuvenation procedure, contact Brown & Brothers to learn your options. Brown & Brothers has 20 years of experience specializing in cases of medical negligence. Simply fill out the online form for a free case review.