Medical Device Injuries

Manufactured by Inmode MD Ltd., FormaV and FractoraV lasers were targeted by the U.S. Food and Drug Administration recently for claims they can be used to treat “sexual dysfunction, vaginal rejuvenation and urinary stress incontinence.” …

The Exilis Ultra 360 System is a type of device used for “vaginal rejuvenation” to treat rhytids and wrinkles. The Exilis Ultra 360 is manufactured by BTL Industries, Inc. and has been marketed to treat …

Monalisa Touch is one of the brands the U.S. Food and Drug recently called out in an effort to combat the misuse of energy-based devices as a means for “vaginal rejuvenation.” Monalisa Touch is a …

ThermiVa is a type of device used in procedures some women undergo in order to address complications they have in their most intimate of regions. ThermiVa is a non-invasive, non-hormonal treatment that uses controlled radiofrequency …

FemiLift is a type of device used in “vaginal rejuvenation” procedures some women undergo in order to address complications they have in their most intimate of regions. FemiLift is one of many brands to be …

The JOULE Multi-Platform System and DiVa Laser Vaginal Therapy are manufactured by Sciton, a company based out of Palo Alto, California. The JOULE device was cleared by the FDA as a laser/light powered device for …

On July 30, 2018, the U.S. Food & Drug Administration (FDA) issued a letter to manufacturers of vaginal laser and energy-based gynecological devices stating that the agency has become aware the devices are being used in an “off-label” fashion and putting women’s health at risk. The lasers are being promoted for “Vaginal Rejuvenation”. Compensation may be available by filing a vaginal rejuvenation lawsuit and the lawyers at Johnson // Becker may be able to help.