MAUDE Adverse Event Report: MENTOR MENTOR; HIGH PROF. GEL BREAST IMPLANT

Model Number EART107339-004F

Device Problem Failure to Osseointegrate (1863)

Patient Problem Tissue Damage (2104)

Event Date 03/18/2015

Event Type  Injury  

Event Description

After years of sickness to include exhaustion and depression, i proceeded to obtain consultation to have my gel implants removed.Due to the high cost in the u.S., i decided to go to a highly reputable surgeon in (b)(6).He requested i undergo various medical exams which included an (b)(6); to my horror the (b)(6) came back (b)(6).How could this be? i have had only one sex partner all of my life.He would not proceed with the surgery due to my results.At that time i pleaded and assure him this was an error.My husband of (b)(6) agreed to be tested and i had a second blood test.His results came back negative mine (b)(6) again.At that time we proceeded with a dna test which came back negative.Even though the blood work and (b)(6) test came back negative one month after removal of the gel breast implants.I continue to have some of the symptoms to include swollen lymph glads and sore throat.Unfortunately, i don't have medical insurance at this time to continue monitoring my condition.Dr.(b)(6) agreed to proceed with the removal of breast implants on (b)(6) 2015.When he opened me up, he found a rupture of the right implant.The surgical procedure took 8 hrs due to the infection surrounding the implant.He put met on antibiotics and had me re-tested for (b)(6).One month after removal of cel breast implants.My blood work came back negative.It is clear that absent removal of the gel implants the autoimmune disease i had due to the leaking of the gel implant would have caused my death.I plead for the fda to completely remove and recall the mentor gel implants from the market as the leaking is life threatening.Event abated after use stopped or dose reduced: yes.

• Brand Name: MENTOR
• Type of Device: HIGH PROF. GEL BREAST IMPLANT
• Manufacturer (Section D): MENTOR; santa barbara CA 93111
• MDR Report Key: 5018286
• MDR Text Key: 23696881
• Report Number: MW5055544
• Device Sequence Number: 1
• Product Code: FWM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/03/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EART107339-004F
• Device Catalogue Number: 5750254-022-026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 64