FDA Adverse Event Summary report: N

SURGITEK HIGH PROFILE SILASTIC IMPLANT, 600/680 CC

MDR report key: 11055 · Received January 25, 1994

Report

Report Number
MW1000485
Date Received
January 25, 1994
Report Date
January 14, 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 A RIGHT MODIFIED MASTECTOMY ON 5/13/85. ON 6/5/86, SHE HAD ANOTHER CO'S TISSUE EXPANDERS IMPLANTED ON 6/17/87. THEY WERE REPLACED WITH A SECOND CO'S BREAST IMPLANTS ON 9/23/86. THE BREAST IMPLANTS WERE REMOVED AND REPLACED WITH A THIRD CO'S TISSUE EXPANDERS ON 6/17/87 AND THIS CO'S SILICONE BREAST IMPLANTS WERE IMPLANTED TO REPLACE THE EXPANDERS ON 9/16/87. ON 9/25/91, RPTR HAD BILATERAL OPEN CAPSULOTOMY AND BREAST RECONSTRUCTION USING ABDOMINAL TRAM FLAPS. IMPLANTS WERE REMOVED AND THERE WAS SIGNIFICANT SCAR CONTRACTURE. RPTR HAS ALSO NOTED/SUSPECTED THE FOLLOWING PROBLEMS: CARCINOMA OF RIGHT BREAST, FIBROCYSTIC OF LEFT, IMPLANT TIGHTNESS, SEVERE CAPSULE FORMATION, RIGHT NIPPLE UNNATURAL IN APPEARANCE, BREAST DRAINAGE, DEPRESSION, FATIGUE, ARM, FINGER AND SHOULDER PAIN, EXPANDERS SHIFTED, OPEN CAPSULOTOMIES, RUPTURE, BREAST SWELLING, BACK PAIN, ALL OVER ACHING, FIBROMYALGIA AND CARPAL TUNNEL, BURSITIS, SCAR CONTRACTURE, MILD ANKYLOSING SPONDYLITIS, CHRONIC MILD MYOFASCIAL SYNDROME, FIRST IMPLANTS LOOKED AWFUL, RIGHT SIDE WAS HARD, AND HAD A LOT OF PAIN, HAD BACK AND SHOULDER PAIN, BURNING, SEARING PAIN IN LEFT BREAST BEFORE SECOND IMPLANTS WERE REMOVED, COULDN'T STAND TO MOVE ARM, IT HURT TO BREATH, MIGRAINES, HIGH BLOOD PRESSURE, ALLERGIES, ULCER, ANXIETY AND PANIC ATTACKS, MULTIPLE BREAST SURGERIES, ARTHRITIS AND SYMPTOMS, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, SWELLING OF HANDS/FINGERS, BREAST TENDERNESS, COLDNESS/PAIN EXTREMITIES, INCORRECT SIZE OF IMPLANTS, SLOSHING NOISES, BREAST LUMPS AFTER IMPLANTS, SHAKING, DOESN'T SLEEP AT NIGHT AND EMOTIONAL. (ALSO SEE MEDWATCH 1000482-484.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SURGITEK HIGH PROFILE SILASTIC IMPLANT, 600/680 CC FTR MEDICAL ENGINEERING CORP. 12868-87C, 12871-87C

Patients

Seq Age Sex Outcome Treatment
1 *