Description of Event or Problem · 1
REPORTER PAID $1,400 FOR 14 ENDERMOLOGIE TREATMENTS - AN FDA APPROVED TREATMENT FOR CELLULITE. SHE WAS TOLD BY THE RN WHO DID THE TREATMENTS THAT THERE WERE NO SIDE EFFECTS. SHE SIGNED SOME DOCUMENTS FROM THE MFR THAT ALSO STATED THERE WERE NO SIDE EFFECTS. REPORTER STARTED TREATMENTS ON JULY 6, 1999; AND HAD TWO TREATMENTS PER WEEK, AS ADVISED. AFTER 6 TREATMENTS SHE STARTED GETTING RED AND BLUE VEINS ON VARIOUS PARTS OF HER BODY. THE RN WHO DID THE TREATMENTS CALLED LPG. MFR EMPLOYEE SAID THAT SOMETIMES THIS HAPPENS, BUT REPORTER SHOULD CONTINUE WITH TREATMENTS AND THEY WILL "GO AWAY". REPORTER HAD 2 MORE TREATMENTS AND THEY GOT WORSE. SHE CALLED LPG AGAIN AND SPOKE TO ANOTHER EMPLOYEE AT MFR ON 7/30/99. "HE WAS VERY RUDE; HE SAID HE 'DOESN'T HAVE ANYTHING TO DO WITH THAT' AND TO 'WORK IT OUT' WITH THE PLACE WHERE I HAD THE TREATMENTS DONE." ON AUGUST 2, REPORTER SPOKE ON THE PHONE WITH MFR EMPLOYEE WHO TRAINED THE RN WHO DID HER TREATMENTS. SHE TOLD THE REPORTER THAT LPG TOLD HER "OFF THE RECORD" THAT THIS CAN HAPPEN. SO THEY KNOW ABOUT IT BUT ARE HIDING IT. ON AUGUST 3, REPORTER WENT TO HER DERMATOLOGIST. SHE SAID THE VEINS WOULD NOT JUST "GO AWAY". REPORTER WOULD NEED SCLEROTHERAPY. IT IS EXPENSIVE, REQUIRES MULTIPLE TREATMENTS, IS PAINFUL, AND HAS 1-2 WEEK RECOVERY PERIODS FOR EACH TREATMENT. THE VEINS CAN BE CAUSED BY "TRAUMA" TO THE AREA.