MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Fatigue (1849); Muscle Weakness (1967); Pain (1994); Tingling (2171); Myalgia (2238); Arthralgia (2355); Numbness (2415); Sleep Dysfunction (2517)

Event Date 05/01/2002

Event Type  Injury  

Event 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.

• Brand Name: SMOOTH SALINE BREAST IMPLANTS
• Type of Device: SMOOTH SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6529584
• MDR Text Key: 74053064
• Report Number: MW5069395
• 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: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADDERALL; CELEBREX ; CLONAZEPAM; FIORECET ; HIGH DOSE VITAMIN D; HYDROCODONE; IBUPROFEN; TYLENOL; VITAMIN C; XYREM
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 66