MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number UNKNOWN SALINE IMPLANT

Device Problems Defective Component (2292); Device Contamination with Chemical or Other Material (2944)

Patient Problems Autoimmune Disorder (1732); No Code Available (3191)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

This complaint was reported via medwatch form # mdr mw5070517 no device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.(b)(4).The product is not returned.

Event Description

It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002.She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms.She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery.She claimed that the implants were removed in 2016.The implants were found with faulty valves and mold.She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her children's immune system were over-reactive to everything.

• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: carl hansen ; north irving, TX 75038-3540 ; 9497893858
• MDR Report Key: 6786582
• MDR Text Key: 82459163
• Report Number: 1645337-2017-00050
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/11/2017

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: Health Professional
• Device Catalogue Number: UNKNOWN SALINE IMPLANT
• Other Device ID Number: UNKNOWN SALINE IMPLANT
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention