Additional Manufacturer Narrative · 1
VISIBLE BRUISING - THAT IS ONE OF THE POTENTIAL SIDE EFFECTS. DIMPLING - THIS MAY SUGGEST POOR TECHNIQUE, THAT THE DR. WAS TOO SUPERFICIAL, DIMPLING IS TYPICALLY SEEN SOON AFTER DEPLOYMENT OF THE THREADS OR IMMEDIATELY WHEN THE THREAD IS DEPLOYED TOO SUPERFICIAL BY THE DR. AS OPPOSED TO A COMPLICATION THAT OCCURS LATER - IT SAYS IT WAS SEEN ALMOST IMMEDIATELY AFTER DEPLOYMENT WHICH IS CONSISTENT WITH A PHYSICIANS ERROR IN DEPLOYMENT. THE REASON THE CONTOUR THREAD IS PLACED ON A 7 INCH NEEDLE IS TO ENABLE THE PHYSICIAN TO CORRECT THIS DURING THE PROCEDURE. THIS IS REVIEWED DURING TRAINING COURSES. SURGEON HAD TO ADJUST THREADS TO MINIMIZE PUCKERING AND DIMPLING AROUND 2 AND 3 WEEKS. FIRST AS MENTIONED, DIMPLING IMPLIES DEPLOYMENT ERROR, TOO SUPERFICIAL. SECOND IF PHYSICIAN "ADJUSTED" THREADS AT 2 AND 3 WEEKS - THEY HAVE BROKEN DOWN THE BIOLOGICAL HOLD AROUND THE BARBS AND SET UP THE PT TO HAVE A FAILED PROCEDURE. THIS IS CRITICAL HEALING PERIOD AND BY ADJUSTING, THE SURGEON BROKE DOWN THE HEALING ARCHITECTURE AROUND THE BARBS WHICH SETS UP THE DEVICE TO FAIL AND NOT HOLD LONG TERM AND EFFICACY FAILURE WOULD BE EXPECTED. PATIENTS ARE DIRECTED NOT TO MOVE OR ADJUST TISSUE DURING THIS PERIOD, THIS IS IN CONTRADICTION TO TRAINING AND ADVICE. IRRITATING THIS TISSUE MAY ALSO STIMULATE AND INFLAME TISSUE TO SET UP FOR COMPLICATION AT A LATER POINT AND MAY HAVE BEEN A REASON THE SCARRING PROBLEMS OCCURRED AROUND THE THREAD. BROW LIFT FELL - THIS IS NOT A COMPLICATION THIS IS A FAILED PROCEDURE, AS WITH EVERY OTHER PROCEDURE SUCCESS IS NOT 100%. PT NEVER SAW ANY IMPROVEMENT - THIS IS INCONSISTENT WITH THE LATER STATEMENT "APPROX 8 TO 9 MONTHS LATER, THREADS NO LONGER APPEARED TO LIFT - WHICH IMPLIES FOR 8 TO 9 MONTHS THERE WAS AN EFFECT. PT NEVER SAW ANY IMPROVEMENT WITH THE SO CALLED BROW LIFT - WE DON'T HAVE THE PT DEMORGAPHICS IF THE PT WAS AN APPROPRIATE CANDIDATE. DON'T HAVE INFO ON DEPLOYMENT TECHNIQUE. WHEN DEPLOYMENT IS PERFORMED APPROPRIATELY IN THE APPROPRIATE PATIENTS, USUALLY THERE IS A TREATMENT EFFECT VISIBLE IMMEDIATELY POST OPERATIVELY, IF THERE IS NO EFFECT, EITHER THE PROCEDURE DID NOT WORK OR THE PT WAS THE WRONG PROFILE, OR THE TECHNIQUE WAS INCORRECT. RAISED AREA APPEARED WHERE ONE THREAD WAS PLACED. SURGEON HAD TO REMOVE PART OF THE THREAD AND PERFORM "SCAR REVISION" - NO DEMOGRAPHIC ON PT AVAILABLE, DON'T KNOW THAT PT WAS APPROPRIATE. TYPICALLY THIS HAPPENS IF THREAD IS PLACED TOO SUPERFICIALLY (SHOULD BE IN SUBCUTANEOUS PLANE), READING ABOUT PUCKERING PHENOMENA ABOVE, THIS ALSO SUGGESTS THIS MAY BE A CASE OF SUPERFICIAL DEPLOYMENT - NO DETAILS AVAILABLE. THREAD REMOVAL USUALLY CORRECTS DIMPLING WHEN DONE EARLY ON. IF THREAD IS POORLY DEPLOYED AND THERE IS A DELAY IN PULLING OUT THREAD OR CORRECTING IT, THIS SKIN DEFORMATION MAY STAY. SCAR REVISION WAS PERFORMED - THERE ARE NO DETAILS, IT IS UNCLEAR WHAT THIS MEANS USUALLY IMPLIES AN ELLIPTICAL INCISION AROUNG A SCAR WITH A PRIMARY CLOSURE TO THIN OUT A SCAR LINE. SCAR WAS NOW VISIBLE ALONG THE THREAD PLACEMENT SITES ALONG CHEEKS AND SCARS - NO DETAILS OF NATURE OF SCAR (HYPERTROPHIC, PIGMENTED, AND PUCKERING?) AND SCAR CONTINUES TO WORSEN, BUT IT IS NOT UNDERSTOOD THE NATURE OF WORSENING. SCARRING IN SEVERAL AREAS OF FACE - THERE IS NO DETAIL REGARDING LOCATION OF THE NATURE OF SCARRING. PT RECEIVED NO BENEFIT - TWO POTENTIAL REASONS: FIRST - IT WOULD SEEM THE THREADS WERE PUT INTO THE WRONG TISSUE PLANE GIVEN THE DIMPLING AND SCARRING COMMENTS. SECOND - THE THREADS WERE MOBILIZED TWICE DURING CRITICAL HEALING PERIODS WEEKS AND WEEK 3.