Safety Information

Early Warning System - Alert Communication

The USFDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication

5 September 2018

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
How to report adverse effects

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, notes that a safety communication has been issued by the USFDA in relation to certain medical devices used to perform vaginal rejuvenation or other vaginal cosmetic procedures. In the interests of patient safety, Medsafe is drawing this to the attention of the New Zealand suppliers and has requested that they review the information and advertising pertaining to the devices they supply and also that they contact their customers to make them aware of the potential health risks.

Patients/Consumers should be aware of the potential risks in having treatment with these devices.

The USFDA is aware that certain device manufacturers in the US may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.

Vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:

To date, the USFDA have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function.

The USFDA statement on this matter can be viewed at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm?utm_campaign=07302018_Statement_vaginal%20rejuvenation&utm_medium=email&utm_source=Eloqua.

The USFDA warning notice can be viewed at:

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm

The Warning letters to the individual companies involved in the US can also be viewed by searching at: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#Recent.

Products Affected

The product is: Energy-based devices to perform vaginal rejuvenation or other vaginal cosmetic procedures

Information for consumers and caregivers

  • Be aware that the USFDA has warned that the safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" or cosmetic vaginal procedures has not been established.
  • Understand that the USFDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
  • Discuss the benefits and risks of available treatment options for vaginal symptoms with your health care provider.
  • If you have undergone treatment for vaginal "rejuvenation" and experienced a complication, you are encouraged to report this to the treatment provider and to Medsafe.
  • Complication can include: serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

 

Information for healthcare professionals

  •  Be aware that the USFDA has warned that the safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" or cosmetic vaginal procedures has not been established.
  • Understand that the USFDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
  • Discuss the benefits and risks of available treatment options for vaginal symptoms with your patients and consumers.
  • If anyone has experience adverse effects from procedures that involved the use of energy-based devices to perform vaginal "rejuvenation", cosmetic procedures, or treat genitourinary symptoms of menopause, sexual dysfunction, or urinary incontinence, please report to Medsafe and the New Zealand device suppliers. 

How to report adverse events

Email devices@moh.govt.nz
Online Adverse Event Report (Consumers) (Microsoft Word document 85 KB, 3 pages)
Post Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415


Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.