MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Swelling (2091); Rupture (2208); Chronic Obstructive Pulmonary Disease (COPD) (2237); Complaint, Ill-Defined (2331); Arthralgia (2355)

Event Date 12/18/1998

Event Type  Injury  

Event Description

I had a saline breast implant rupture (b)(6).On (b)(6) i had neck fusion.Woke up systemically ill and in widespread body pain.Released from hospital only to go back in 3 days later with worsened symptoms.I was near death and couldn't figure out what happened.Bedridden 9 years and on narcotics for pain.Doctors were baffled because lab testing was normal for some time.Then, my ana, c-reactive protein and other tests were elevated.Years later i was diagnosed with copd and for 6 years.It resolved with detoxing and i have residual lung scarring but no asthma or copd.I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses.I was on biologic drugs several years without any relief of joint pain or swelling.I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellon's, ulcerative colitis and neuropathy.

• Brand Name: SALINE BREAST IMPLANT
• Type of Device: SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6975814
• MDR Text Key: 90312076
• Report Number: MW5072937
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 65 YR
• Patient Weight: 75