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16 Oct / 2021

Amber’s Edit: Vaginal Rejuvenation Adverse Events Reported to the FDA

Amber's Edit

Study Reveals Adverse Events Linked to Device-Assisted Vaginal Rejuvenation Procedures

As women, we are often pressured to look younger and make attempts to improve the way we look from head to toe. Many women who have had children or who have gone through menopause report a variety of vaginal and pelvic symptoms and conditions that can be chronic and debilitating. Such symptoms and conditions include, among others, the following:

  • Lichen sclerosus
  • Vulvar pain
  • Urethral pain
  • Dyspareunia, which is pain during sexual intercourse
  • Urinary incontinence
  • Vaginal atrophy

Vaginal rejuvenation procedures utilize lasers and energy-based devices that have been linked to serious injuries in many women. According to an article published by the American Society for Laser Medicine & Surgery, Inc., the most common adverse event reported to the Food and Drug Administration (FDA) is pain (including vaginal pain, bladder pain, urethral pain, and unspecified pain).

As of January 2019, a total of 45 separate adverse events had been reported to the FDA concerning injuries associated with device-assisted vaginal rejuvenation procedures. Given the significant number of adverse events, and the similarity of the adverse events, a study was conducted to determine whether the devices used in vaginal rejuvenation procedures are safe enough.

Multiple Vaginal Rejuvenation Adverse Event Reports Become Subject of Recent Study Concerning Safety

Adverse events concerning medical devices are reported in the Manufacturer and User Facility Device Experience (MAUDE) database, which is publicly available. After identifying numerous adverse events linked to vaginal rejuvenation procedures reported to the MAUDE database, doctors felt it was necessary to further study the adverse events for safety concerns.

The study, which is titled “Lasers and energy-based devices marketed for vaginal rejuvenation: A cross-sectional analysis of the MAUDE database,” sheds light on the dangers of device-assisted vagina rejuvenation procedures that may not otherwise be known. According to the study, women who experienced injuries after undergoing device-assisted vaginal rejuvenation procedures sought medical care for the treatment of the following:

  • Long-term pain;
  • Numbness;
  • Burning;
  • Bladder disturbances;
  • Infections;
  • Scarring;
  • Dyspareunia (pain during sexual intercourse);
  • Worsening of the symptoms the vaginal rejuvenation procedure was intended to address;
  • Aggravation of lichen sclerosus; and
  • Disfigurement.

Unfortunately, women who have suffered injuries following vaginal rejuvenation procedures are suffering from conditions that the vaginal rejuvenation procedure is supposed to cure. Such an outcome is not unlike the use of transvaginal mesh to treat urinary incontinence and pelvic organ prolapse. Rather than treat the conditions at issue, transvaginal mesh proved to cause more harm than good for many women.

The devices used in vaginal rejuvenation procedures are no different. Without a medical device industry that will properly warn patients, all patients must arm themselves with knowledge to ensure they are making decisions that are in their best interests. Far too many women have fallen victim to miracle procedures that turn out to be nothing more than a big nightmare.

Impacted by a Vaginal Rejuvenation Procedure? Get Mad With Me.

Have you suffered injuries following a vaginal rejuvenation procedure? Find out whether you may be entitled to compensation by speaking with me about your situation. Many medical devices have proven to be dangerous for women, and devices used in vaginal rejuvenation procedures are no exception.

I am an experienced personal injury lawyer in Atlanta and routinely handle complex cases involving medical devices. My goal is to make every effort to protect my clients’ rights to pursue legal action. I am a woman too. Hear me when I say that you deserve a full and impartial evaluation of your potential legal claims.  We have offices in Alpharetta and Cumming for your convenience.  

Stay safe out there, 

Amber Gilormo, Esq.

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