STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

Report

Report Number: 9617229-2019-03191
Event Type: Injury
Date Received: April 24, 2019
Date of Event: January 28, 2019
Report Date: April 24, 2019
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
PMA / PMN Number: P040046
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ARTICLE CITATION: 'ENDOSCOPIC TRANSAXILLARY VERSUS INFRAMAMMARY APPROACHES FOR BREAST AUGMENTATION USING SHAPED IMPLANTS: A MATCHED CASE¿CONTROL STUDY' DONG WON LEE, SOO JUNG KIM, HANJO KIM; 28 JANUARY 2019 SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE AND INTERNATIONAL SOCIETY OF AESTHETIC PLASTIC SURGERY 2019. THE EVENT OF CAPSULAR CONTRACTURE, HEMATOMA, AND WOUND DEHISCENCE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem · 1

THROUGH JOURNAL ARTICLE ¿ENDOSCOPIC TRANSAXILLARY VERSUS INFRAMAMMARY APPROACHES FOR BREAST AUGMENTATION USING SHAPED IMPLANTS: A MATCHED CASE¿CONTROL STUDY¿, THE FOLLOWING ADVERSE EVENTS WERE REPORTED: CAPSULAR CONTRACTURE (BOTH GRADE III AND IV REPORTED)- OCCURRING IN 10 PATIENTS; HEMATOMA- OCCURRING IN 4 PATIENTS; AND WOUND PROBLEM (WOUND DEHISCENCE)- OCCURRING IN 1 PATIENT. SIDE EXPERIENCING EVENT IS UNKNOWN. STATUS OF DEVICES IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
337162	STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention