Description of Event or Problem · 0
IN (B)(6) 2022, I UNDERWENT TWO SESSIONS OF THE MONALISA TOUCH PROCEDURE (A LASER-BASED VAGINAL REJUVENATION TREATMENT), 6 WEEKS APART. (THE PROCEDURE IS SUPPOSED TO TAKE PLACE OVER THREE SESSIONS BUT I CANCELED THE THIRD.) THE REASON I HAD THIS TREATMENT WAS TO ALLEVIATE PAIN DURING INTERCOURSE, IN MY CASE AS A RESULT OF MENOPAUSE. I WAS TOLD THAT THE PROCEDURE IS PAINLESS AND RISK-FREE AND THAT PATIENTS TYPICALLY EXPERIENCE RELIEF QUICKLY, SOMETIMES AFTER THE FIRST SESSION. (NOTE: THERE WAS A LARGE POSTER IN THE DOCTOR'S WAITING ROOM ADVERTISING THE PROCEDURE, WITH NO MENTION ABOUT RISKS OR SIDE EFFECTS. TWO MONTHS LATER, I LEARNED THAT THE FDA HAD ISSUED A WARNING TO CONSUMERS ABOUT THE DANGER OF THIS TYPE OF PRODUCT.) RATHER THAN EXPERIENCING ANY RELIEF, I EXPERIENCED SIGNIFICANTLY INCREASED PAIN DURING INTERCOURSE, WHICH I CAN BEST DESCRIBE AS FOLLOWS: PRIOR TO HAVING THE PROCEDURE, THE PAIN HAD PRIMARILY OCCURRED UPON PENETRATION AND HAD FELT AS THOUGH THE PENIS WAS BREAKING THROUGH A BARRIER, BUT AFTER THAT, THE PAIN GENERALLY EASED UP AND INTERCOURSE SOMETIMES BECAME PLEASURABLE. SINCE HAVING THE TWO MONALISA TOUCH SESSIONS, HOWEVER, THE PAIN IS MUCH MORE SEVERE. ADDITIONALLY, THE PAIN IS NOT JUST UPON ENTRY, BUT THROUGHOUT ALL OF INTERCOURSE. FURTHER, THE PAIN DOES NOT JUST OCCUR AT THE BEGINNING OF THE VAGINA BUT THE WHOLE WAY THROUGH, LIKE A BURNING SENSATION. THE PAIN IS SO SEVERE THAT I HAVE HAD TO CLENCH MY TEETH AND THEN DISCONTINUE INTERCOURSE. I DISCUSSED THIS ADVERSE OUTCOME WITH THE DOCTOR, WHO SAID SHE HAD NEVER HAD A PATIENT EXPERIENCE INCREASED PAIN FROM THE PROCEDURE, AND RECOMMENDED THAT I NOT GO THROUGH WITH THE THIRD SESSION BECAUSE SHE DIDN'T WANT TO HURT ME ANY MORE. DUE TO THE PROBLEMS THIS PROCEDURE CAUSED, I DID RESEARCH AND LEARNED THAT THE FDA HAD ISSUED A WARNING NOTICE TO PROVIDERS AND PATIENTS REGARDING THE USE OF VAGINAL LASERS FOR VAGINAL REJUVENATION. THE NOTICE SAID THAT THE FDA HAS "FOUND NUMEROUS CASES OF VAGINAL BURNS, SCARRING, PAIN DURING SEXUAL INTERCOURSE, AND RECURRING OR CHRONIC PAIN" AND THAT "THESE REPORTS INDICATE THAT THESE PROCEDURES CAN CAUSE SERIOUS HARM." YET I WAS NEVER GIVEN INFORMATION ABOUT THIS POTENTIAL HARM. I AM CONCERNED THAT MY VAGINAL TISSUE MIGHT HAVE BEEN BURNED AND IRREPARABLY DAMAGED, AFFECTING MY SEXUAL HEALTH AND SEXUAL RELATIONSHIP WITH MY HUSBAND. THE FDA NOTICE ALSO REFERRED TO THE "DECEPTIVE MARKETING OF UNPROVEN TREATMENTS," WHICH I FEEL I WAS CERTAINLY A VICTIM OF, GIVEN THE LARGE, APPEALING POSTER OF THE MONALISA TOUCH PROCEDURE IN THE DOCTOR'S WAITING ROOM, WITH NO CAUTION ABOUT THE RISKS. CYNOSURE. FDA SAFETY REPORT ID # (B)(4).