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. SILASTIC ROUND BREAST IMPLANT   back to search results
Catalog Number 590
Event Description

10/10/74 bilateral breast augmentation using silicone gel breast implants. Since that time rptr has been suffering from muscular pain and stiffness in her neck, back and shoulder. She has been diagnosed with fibrositis, an autoimmune connective tissue disease. A physical exam by a plastic surgeon reveals capsular contractures as well as calcification of both capsules in the breasts. Xeromammogram and ultrasound confirm bilateral ruptures of implants. Her internist states her past medical history is significant for fibrositis, hypothyroidism, depression, allergic rhinitis, leaking breast implant, hormone imbalance, alopecia, infertility and miscarriage, temporomandibular joint dysfunction or myofascial pain syndrome and dermatitis. Her symptoms are consistent with silicone associated illness.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameSILASTIC ROUND BREAST IMPLANT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DOW CORNING CORP.
midland MI 48686
Device Event Key12579
MDR Report Key12579
Event Key8763
Report NumberMW1001469
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 03/09/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/1994
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device Catalogue Number590
Device LOT NumberHH0243
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 06, 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