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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS
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MENTOR SMOOTH SALINE BREAST IMPLANTS Back to Search Results
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Emotional Changes (1831); Fatigue (1849); Muscle Weakness (1967); Pain (1994); Tingling (2171); Myalgia (2238); Arthralgia (2355); Numbness (2415); Sleep Dysfunction (2517)
Date of Event 05/01/2002
Type of Reportable Event Serious Injury
Event or Problem Description
I had mentor smooth saline breast implants placed in 1998.Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain.By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain.In 2011, my right implant was encapsulated with severe intermittent pain.I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue.In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain.Other generalized symptoms included night sweats, increased emotional lability, nocturia, muscle weakness, loss of strength in my arms and hands, intermittent numbness and tingling in hands and feet, raynaud's like symptoms in my feet, calcified right breast encapsulation, and progressive joint pain in hands and wrists.All symptoms continued to worsen until surgical removal with total encapsulectomy bilaterally in (b)(6) of 2017.
 
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Brand Name
SMOOTH SALINE BREAST IMPLANTS
Common Device Name
SMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6529584
Report NumberMW5069395
Device Sequence Number12342415
Product Code FWM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1998
Device Explanted Year2017
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 04/26/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/26/2017
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ADDERALL; CELEBREX ; CLONAZEPAM; FIORECET ; HIGH DOSE VITAMIN D; HYDROCODONE; IBUPROFEN; TYLENOL; VITAMIN C; XYREM
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age55 YR
Patient Weight66
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