MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for SALINE BREAST IMPLANTS MENTOR 35-3270 manufactured by Mentor.
[110699811]
Shortly after receiving saline mentor implants breast in 2003, i began having problems and severe neck pain and headaches. I had a discectomy and laminectomy with a triad allograft in 2004 continued experiencing problems with grip and coordination which escalated until i walked with a cane for years. I was healthy before implants but was diagnosed with several different auto immune diseases after implants. Not sure if they are the cause but my children think so and the disease keep accumulating. Original diagnosis was neuropathy which a few years went to graves disease, multiple sclerosis diagnosis. Fibromyalgia, sjogrens, problems with swallowing dysphagia, chronic heartburn, gerd's, cns neuropathy, thrombophlebitis. Brain lesions, positive for 23 kda and 41 kd bands only on lyme test consistently, arthritis and/or swelling of extremities, fatigue, memory problems. Visions, hearing, mood swings, insomnia, changes in nail bed, difficulty walking, breathing difficulties, etc. Breast lesions high risk multiple biopsies, add'l growth of cysts, back pain and burning in back, chest pain, carpal tunnel syndrome or ulnar nerve neuropathy, etc. Dates of use: 15 years. Diagnosis or reason for use: bigger boobs, breast augmentation. Name and strength: im sm rm sal fill mamm prosh, mfr: mentor, lot # 258250 or 58; hi pro sm ru sal fill mamm prosh, mentor, lot # 250926.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077705 |
| MDR Report Key | 7582283 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-05 |
| Date of Event | 2004-04-01 |
| Date Added to Maude | 2018-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SALINE BREAST IMPLANTS |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2018-06-07 |
| Model Number | MENTOR 35-3270 |
| Lot Number | 257250 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Brand Name | SALINE BREAST IMPLANTS |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2018-06-07 |
| Model Number | MENTOR 35-3270 |
| Lot Number | 259926 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Brand Name | ALLOGRAFT, TRIAD |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NUN |
| Date Received | 2018-06-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2018-06-07 |