FDA Adverse Event Injury Summary report: N

NOVASURE

MDR report key: 2150764 · Received June 29, 2011

Report

Report Number
MW5021227
Event Type
Injury
Date Received
June 29, 2011
Date of Event
November 12, 2004
Report Date
June 29, 2011
Manufacturer
HOLOGIC
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2004, MY OB/GYN PERFORMED AN ENDOMETRIAL ABLATION USING THE (B)(4). I WAS UNDER GENERAL ANESTHESIA. THIS PROCEDURE WAS RECOMMENDED BY MY OB/GYN TO RELIEVE PAINFUL AND HEAVY PERIODS. ACCORDING TO OP RECORDS, MY OB/GYN UTILIZED 2 MINS OF 103 JOULES TO THE MESH THEN REMOVED IT. I CONTINUED TO "SPOT" MONTHLY AFTER THE PROCEDURE AND GRADUALLY (OVER A FEW MONTHS) THE PAIN I HAD BEEN EXPERIENCING PRIOR, HAD RETURNED AND GOTTEN SIGNIFICANTLY WORSE. EVERY MONTH I WOULD SPOT AND THE PAIN WOULD INCREASE IN INTENSITY AND SEVERITY. SEVEN MONTHS AFTER THE PROCEDURE, MY PAIN WAS EXCRUCIATING, CAUSING ME TO BE IMMOBILE, NAUSEOUS, AND AT TIMES, FEELING AS IF I WOULD PASS OUT IF I TRIED TO MOVE OR STAND. I INFORMED MY OB/GYN OF THESE ADVERSE REACTIONS ON SEVERAL OCCASIONS. I WAS INSTRUCTED TO TAKE IBUPROFEN AND USE A HEATING PAD. IN (B)(6) 2005, MY OB/GYN INSTRUCTED TO ME TO COME TO HIS OFFICE WHILE EXPERIENCING THIS PAIN. DURING THAT VISIT, HE TOLD ME THAT MY PAIN HAD NOTHING TO DO WITH THE ABLATION AND ACCUSED ME OF "OVERREACTING" AND ADVISED ME TO TAKE OVER THE COUNTER PAIN MEDICATION AND ADDED THAT HE DID NOT FEEL COMFORTABLE PRESCRIBING PAIN MEDICATION FOR IT - WHICH I HAD NOT ASKED FOR. THE FOLLOWING MONTH, (B)(6) 2005, WHEN THE PAIN BECAME UNBEARABLE, INSTEAD OF RETURNING TO MY OB/GYN, I CALLED MY PRIMARY CARE PHYSICIAN WHO SAW ME RIGHT AWAY AND SENT ME TO THE EMERGENCY ROOM FOR EVAL. THE EMERGENCY ROOM ADMITTED ME, DID AN ABDOMINAL MRI, AND HELD ME OVERNIGHT. THE SURGEON RELEASED ME THE NEXT DAY STATING I WAS NOT A "SURGICAL" CANDIDATE. THE MRI SCANNED ONLY MY ABDOMEN, NOT MY PELVIC AREA - BUT THE SURGEON WAS CONFIDENT THAT IT WAS "GASTROENTERITIS." AS A MEDICAL PROFESSIONAL MYSELF - I WAS CONFIDENT HE WAS WRONG. THE FOLLOWING MONTH, (B)(6) 2005, WHEN THE PAIN RETURNED, I REPORTED TO A DIFFERENT (BETTER) EMERGENCY ROOM WHERE A COMPLETE MRI AND PELVIC ULTRASOUND WERE PERFORMED. I WAS GIVEN PAIN MEDICATION, A REFERRAL TO A GYNECOLOGICAL SURGEON, AND A REPORT OF ABNORMALITIES IN MY UTERUS. THAT SURGEON RECOMMENDED COMPLETE HYSTERECTOMY. NOT WANTING TO RUSH INTO SUCH A SERIOUS SURGERY, I CONSULTED ANOTHER SURGEON FOR A SECOND OPINION. THAT SURGEON CONCURRED WITH THE PREVIOUS RECOMMENDATION AND MY HYSTERECTOMY WAS PERFORMED ON (B)(6) 2006. THE SURGEON STATED MY UTERUS WAS LARGE, DISTORTED, FILLED WITH FIBROSIS AND ADENOMYOSIS. BOTH SURGEONS VERBALIZED CONCERN HOW THESE SYMPTOMS RAPIDLY INCREASED IN INTENSITY AND FREQUENCY FOLLOWING THE (B)(4) ENDOMETRIAL ABLATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NOVASURE UTERINE MESH FTL HOLOGIC UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 42 YR Other