MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANTS; PROSTHESIS BREAST

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Capsular Contracture (1761); Dehydration (1807); Dry Eye(s) (1814); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Inflammation (1932); Pain (1994); Rash (2033); Visual Impairment (2138); Tingling (2171); Dizziness (2194); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Impaired Healing (2378); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
Date of Event	02/10/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were "safe".I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds.Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on.My hormones are completely of whack.I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs.Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain.Premature aging, vision disturbances, digestive issues.Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks.Depression, diagnosed in 1990 with ms 3 years after original silicone implants.

• Brand Name: SMOOTH SALINE IMPLANTS
• Common Device Name: PROSTHESIS BREAST
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6875906
• Report Number: MW5072200
• Device Sequence Number: 1114419
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/17/2017
• 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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Disability
• Patient Age: 56 YR
• Patient Weight: 54