MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANTS PROSTHESIS BREAST

Device Problem Insufficient Information (3190)

Patient Problems 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)

Event Date 02/10/2005

Event Type  Injury  

Event 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
• Type of Device: PROSTHESIS BREAST
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6875906
• MDR Text Key: 86830423
• Report Number: MW5072200
• 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: 09/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 09/18/2017 Patient Sequence Number: 1