FDA Concerns about Laser Devices

Virginia Women’s Center offers the MonaLisa Touch® procedure to patients suffering from vaginal atrophy that results in painful intercourse, vaginal dryness, burning, and itching.

You may have heard that the FDA recently contacted the manufacturer of MonaLisa Touch and other similar devices, with concerns regarding the accuracy of their marketing messaging.

Years ago, the FDA approved the use of the MonaLisa Touch for general gynecological indications including incision, excision, ablation, vaporization, and coagulation of body soft tissues. However, the FDA has not specifically approved the device for vaginal rejuvenation in the United States. At Virginia Women’s Center, we take patient safety very seriously. However, we also know it’s important to keep on the cutting-edge of technological advances to best serve our patients.

Virginia Women’s Center is committed to providing women with the personal care they deserve. Since 2015 we have successfully treated hundreds of women suffering from menopause-related vaginal symptoms using the MonaLisa Touch, without any serious side effects. We believe this is a safe, effective treatment option for women who can’t take or don’t want hormone containing therapies. If you have questions about the FDA’s warnings, please reach out to Virginia Women’s Center’s Drs. Kristin Schraa or Peter Wilbanks, 804.288.4084.

Below is a list of studies supporting the efficacy and safety of the MonaLisa Touch for use in managing the symptoms of vaginal atrophy.

https://www.ncbi.nlm.nih.gov/pubmed/29286986

https://www.ncbi.nlm.nih.gov/m/pubmed/29726916/

https://www.ncbi.nlm.nih.gov/pubmed/29795970

https://www.ncbi.nlm.nih.gov/pubmed/28881431

https://www.ncbi.nlm.nih.gov/pubmed/28866727

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5584900/

https://www.ncbi.nlm.nih.gov/pubmed/28056209

https://www.ncbi.nlm.nih.gov/pubmed/27823733

https://www.ncbi.nlm.nih.gov/pubmed/27170261

https://www.ncbi.nlm.nih.gov/pubmed/27558459

https://www.ncbi.nlm.nih.gov/pubmed/27404032

https://www.ncbi.nlm.nih.gov/pubmed/27648595

https://www.ncbi.nlm.nih.gov/pubmed/27383297

https://www.ncbi.nlm.nih.gov/pubmed/25333211

https://www.ncbi.nlm.nih.gov/pubmed/25596815

https://www.ncbi.nlm.nih.gov/pubmed/24605832

https://www.ncbi.nlm.nih.gov/pubmed/28843942

https://www.ncbi.nlm.nih.gov/pubmed/26536212

https://www.ncbi.nlm.nih.gov/pubmed/29492713