Our Philadelphia vaginal rejuvenation injury lawyers are evaluating cases involving side effects / injuries sustained by women who have undergone vaginal rejuvenation procedures. Vaginal rejuvenation involves the tightening or reconstruction of a patient’s female genitalia. Alternate terms for vaginal rejuvenation include:

  • female genital rejuvenation surgery
  • female genital cosmetic surgery
  • female genital plastic surgery
  • designer vagina surgery
  • vulvovaginal plastic surgery

Physicians often use medical devices known as energy-based devices to perform these procedures. These devices, which are not FDA-approved for vaginal rejuvenation, use radio frequency and lasers that can cause serious injury to patients. Injuries from vaginal rejuvenation procedures performed with energy-based medical devices include:

  • nerve damage causing pain or loss of sensation
  • loss of sensation from scarring
  • sexual dysfunction
  • bladder and / or kidney injury
  • vaginal burns
  • infection
  • severe and chronic pain

Vaginal Rejuvenation FDA Warnings

On July 30, 2018, the U.S. Food & Drug Administration (FDA) issued a warning “against use of energy-based devices to perform vaginal ‘rejuvenation’ or vaginal cosmetic procedures.” The stated purpose of the warning was to alert healthcare providers and patients that “serious adverse events” are associated with use of these devices to perform:

  • vaginal rejuvenation
  • cosmetic vaginal procedures
  • certain non-surgical vaginal procedures

The warning also stated that the FDA has not approved use of energy-based devices for any of these procedures, including procedures to treat:

  • vaginal laxity, dryness, or atrophy
  • pain during intercourse
  • pain during urination
  • loss of sexual sensation
  • other symptoms related to sexual function, urinary incontinence, or menopause

The FDA also sent warning letters to device manufacturers that may have improperly marketed the devices for these unapproved uses. These include:

  • Alma Lasers (manufacturer of FemiLift)
  • BTL Industries, Inc. (manufacturer of Exilis Ultra 360)
  • Cynosure, Inc. (manufacturer of MonaLisa Touch)
  • Inmode MD, Inc. (manufacturer of FormaV, FractoraV)
  • Sciton, Inc. (manufacturer of JOULE DiVa)
  • Thermigen, Inc. (manufacturer of THERMiva)

Vaginal Rejuvenation Lawsuits

Lawsuits instituted by Philadelphia vaginal rejuvenation injury lawyers may allege that the manufacturers of energy-based medical devices used to perform vaginal rejuvenation:

  • produced and marketed unreasonably dangerous products / medical devices
  • knew or should have known of the dangerous side effects associated with use of energy-based medical devices for vaginal rejuvenation procedures
  • engaged in deceptive and illegal marketing of these devices
  • marketed and sold these devices for use in vaginal rejuvenation without FDA approval for their use in these procedures
  • violated federal law by marketing medical devices for a purpose not approved by the FDA

Contact our Philadelphia Vaginal Rejuvenation Injury Lawyers

If you suffered injuries as a result of a vaginal rejuvenation procedure employing an energy-based medical device, you may be entitled to compensation from the device manufacturer. Contact our Philadelphia vaginal rejuvenation injury lawyers, today, for a free evaluation of your case.