FDA Adverse Event Injury Summary report: N

SILASTIC MAMMARY IMPLANT

MDR report key: 170229 · Received May 29, 1998

Report

Report Number: 1816403-1998-00248
Event Type: Injury
Date Received: May 29, 1998
Date of Event: April 30, 1998
Report Date: April 30, 1998
Manufacturer: DOW CORNING CORP.
Product Code: FTR
Adverse Event: Yes
Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

METHODS: ENVELOPE THICKNESS MEASUREMENT. WEIGHT MEASUREMENT. FEATURE DIMENSIONAL MEASUREMENT. MICROSCOPIC EXAMINATION. RESULTS: LOSS OF SHELL INTEGRITY, ENVELOPE SLIT. CREASE LINES. SLIGHT AMBER COLOR. LOSS OF SHELL INTEGRITY, ENVELOPE TEAR. WEIGHT LESS THAN SPECIFIED. FOREIGN MATERIAL IN GEL. AMBER COLOR. WEIGHT MEASUREMENT. ENVELOPE THICKNESS. CONCLUSIONS: COLOR WITHIN SPECIFICATIONS. CREASES AND/OR WEAR RESULT OF FOLDING ACTION IN-VIVO. AMBER COLOR CONDITION OF AGING. CAUSE OF TEAR(S) UNDETERMINED. GEL NOT ALL RETURNED. FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED. TEAR(S) CAUSED BY STRESS. ENVELOPE THICKNESS WITHIN SPECIFICATION LIMITS. SLITS CAUSED BY SHARP OBJECT CONTACT. WEIGHT LOW DUE TO GEL MISSING.

Description of Event or Problem · 1

BILATERAL BREAST CAPSULAR CONTRACTURES RUPTURED RIGHT BREAST IMPLANT. BILATERAL REMOVAL OF SILICONE IMPLANTS, REPLACED WITH SALINE IMPLANTS. IMPLANTS IMPLANTED AT MEMORIAL HOSPITAL IN MARTINSVILLE, VA 24111, 2/2/82. REPORTER (ADDITIONAL INFORMATION RECEIVED WHEN DEVICES WERE RETURNED) ALLEGES CAPSULATION OF LEFT BREAST WITH CLOSED CAPSULOTOMY AND OPEN CAPSULECTOMY, BREAST MASS RIGHT "INDURATION ALONG INNER ASPECT/IMPLANT PROBLEM ENCAPSULATION", ABNORMAL MASSES IN BREASTS, RIGHT BREAST LESION EXCISION AND LEAKING IMPLANT RIGHT BREAST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SILASTIC MAMMARY IMPLANT Implant	MAMMARY IMPLANT, GEL-FILLED	FTR	DOW CORNING CORP.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	*		Other\| R