FDA Adverse Event Summary report: N

NATURAL Y POLYURETHANE MAMMARY IMPLANT, 350 CC

MDR report key: 17129 · Received October 24, 1994

Report

Report Number
MW1003786
Date Received
October 24, 1994
Report Date
February 11, 1994
Manufacturer
MEDICAL ENGINEERING CORP.
Product Code
FTR
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RPTR HAD THESE IMPLANTS PLACED IN SUBCUTANEOUS POCKET TO REPLACE SUBPECTORAL IMPLANTS. ON 5/31/90 SHE HAD EXCISIONAL BIOPSY AND FROZEN SECTION OF LEFT BREAST MASS. NODULE WAS REMOVED BY "PIECEMEAL". IT WAS ADHERENT TO IMPLANT WHICH WAS INADVERTENTLY PUNCTURED. THERE WAS A 3-4 MM SIZE RENT WHICH WAS REPAIRED WITH 3-0 ABSORBABLE SYNTHETIC SUTURE IN CONTINUOUS STITCHES. THERE WAS NO LEAK. THE IMPLANTS WERE REPLACED 10/13/92 DURING A CAPSULECTOMY. BOTH IMPLANTS WERE RUPTURED WITH GEL FLOATING INSIDE THE POCKETS. RPTR ALSO COMPLAINS OF THE FOLLOWING: FIBROCYSTIC BREASTS, CHRONIC INFLAMMATION/FOREIGN GIANT CELL GRANULOMA, LIPOMA BREAST: DEFORMITIES, DISCOMFORT, PAIN, MULTIPLE OPERATIONS, CAPSULAR CONTRACTURES, HEMATOMAS, BRUISING, DISCOLORATION, SEVERE PAIN, ADHESIONS, SWELLING, ASYMMETRY, IMPLANT FOLDS, EXCESSIVE BLEEDING, IMPLANT WRINKLES, INCORRECT SIZE OF IMPLANTS, ASYMMETRY, MALPOSITION OF IMPLANTS, VISIBLE WRINKLES OF IMPLANTS, SLOSHING NOISES FROM IMPLANTS, CLOSED CAPSULOTOMIES 3/16/81, 3/30/81, 1/29/82 - UNSUCCESSFUL, 3/2/82 - UNSUCCESSFUL, ARM AND SHOULDER DISCOMFORT, CHEST PAIN (PROBABLY GI OR MUSCULOSKELETAL, TMJ, APICAL SYSTOLIC MURMUR, BREAST MASSES, BACK PAIN AND HEMATURIA, CHRONIC ARTHRITIC SYMPTOMS IN NECK, BACK, CHEST, ARMS, SWOLLEN LYMPH NODES IN NECK, SINUSITIS, RIGHT LUNG PAIN, IMPLANT RUPTURES, NEUROFIBROMAS, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, HARDENING OF SKIN AROUND IMPLANT, SWELLING OF FINGERS AND HANDS, UNEXPLAINED RASHES, BREAST TENDERNESS, FATIGUE, GENERAL ACHING AND STIFFNESS, HAIR LOSS, AND COLDNESS AND PAIN OF EXTREMITIES, RAYNAUDS, FIBROMYALGIA AND NON-SPECIFIC AUTO-IMMUNE CONDITION. (ALSO SEE 1003783- 1003785 AND 1003787.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NATURAL Y POLYURETHANE MAMMARY IMPLANT, 350 CC Implant BREAST IMPLANT FTR MEDICAL ENGINEERING CORP.

Patients

Seq Age Sex Outcome Treatment
1 *