FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule

Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DOW CORNING CORP. SILICONE BREAST IMPLANT, 340 CC   back to search results
Lot Number H100940
Event Description

Rptr had bilateral breast implants in 1981 and removal because of rupture in 1993. Surgeon report states: "it was immediately obvious that the implant had ruptured. The implant was splayed out over the chest wall and into the axilla. Using both electrocautery and scissor dissection the thinly encapsulated silicone was dissected across the medial aspect of the chest wall, inferiorly, and laterally into the axilla. Superiorly the silicone was scooped out of the soft tissue and removed from the operative field. The chest defect was irrigated with warm saline, and multiple lapartomy sponges were used to remove any additional silicone from the area. The chest was inspected for bleeding; bleeding was controlled by electrocautery. The chest was packed. Attention was turned to the left anterior chest. It was immediately obvious that this implant had also ruptured. This implant herniated across the midline of the chest, and the herniated silicone was dissected out from underneath the cleavage. Dissection was carried inferiorly, laterally into the axilla, and superiorly where thinly encapsulated silicone was present. The silicone again was scooped out from the soft tissue and removed from the operative field. The left chest defect was irrigated with saline and removed using multiple lap pads. Bleeding was controlled by electrocautery. The wound was packed. " (*).

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameSILICONE BREAST IMPLANT, 340 CC
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DOW CORNING CORP.
midland MI 48686
Device Event Key11816
MDR Report Key11816
Event Key7911
Report NumberMW1000935
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 02/15/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/01/1994
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device LOT NumberH100940
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH