MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-12 for NATRELLE SILICONE GEL FILLED 45-700 manufactured by Allergan.
[64996050]
Patient with history of breast cancer and double mastectomy, reports complications with natrelle cohesive silicone breast implants. Patient decided to have breast reconstruction after her mastectomy in 2008. She states she did not want the cohesive implant, however the surgeon explained she would not be a candidate for saline breast implants due to reconstructive tissue. The patient was implanted with tissue expanders following her mastectomy. The left tissue expander ruptured during chemotherapy treatment, and was replaced with a new one. In (b)(6)2009, the patient had her breast implant procedure where she also implanted alloderm surgical mesh to hold implants in place. She states the left-sided mesh separated and was replaced with a new one. Over the last 8 years, patient states she experienced pain and periodic rashes around her armpits and implant area. She also had bulging, callous, and discoloration/irritation around the left breast and armpit. Patient had an mri done in (b)(6) 2016 and found the left breast implant had ruptured and the gel escaped from the scar capsule. The gel traveled to her lymphatic system into her lymph nodes on the right side of her body. The surgeon who implanted the device states the gel cannot travel and this event occurred from something else. The doctor was unable to remove the material due to expected lymphedema problems. Since the rupture patient states she has developed 3 auto-immune disease, including celiac disease, as well as cellulitis, weight loss, dermatitis, rosacea, microscopic colitis, occipital neuralgia, difficulty swallowing, stomach issues, headache, and fatigue. Patient reports she has developed sensitivity to smell, gluten, wheat, dairy, and antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067193 |
| MDR Report Key | 6249059 |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-12 |
| Date of Event | 2008-10-06 |
| Date Added to Maude | 2017-01-13 |
| 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 | NATRELLE SILICONE GEL FILLED |
| Generic Name | BREAST IMPLANTS |
| Product Code | FTR |
| Date Received | 2017-01-12 |
| Catalog Number | 45-700 |
| Lot Number | 14036204 |
| Device Expiration Date | 2013-11-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Brand Name | NATRELLE SILICONE GEL FILLED |
| Generic Name | BREAST IMPLANTS |
| Product Code | FTR |
| Date Received | 2017-01-12 |
| Catalog Number | 20-750 |
| Lot Number | 13906509 |
| Device Expiration Date | 2013-11-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Brand Name | NATRELLE EXPANDER |
| Generic Name | TISSUE EXPANDER |
| Product Code | LCJ |
| Date Received | 2017-01-12 |
| Model Number | 133FV |
| Catalog Number | 6997 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Brand Name | NATRELLE EXPANDER |
| Generic Name | TISSUE EXPANDER |
| Product Code | LCJ |
| Date Received | 2017-01-12 |
| Model Number | 133FV |
| Catalog Number | 6997 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Brand Name | NATRELLE EXPANDER |
| Generic Name | TISSUE EXPANDER |
| Product Code | LCJ |
| Date Received | 2017-01-12 |
| Model Number | 133FV |
| Catalog Number | 6997 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Brand Name | ALLODERM 18 X 16 |
| Generic Name | SURGICAL MESH |
| Product Code | OXH |
| Date Received | 2017-01-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | ALLODERM 18 X 16 |
| Generic Name | SURGICAL MESH |
| Product Code | OXH |
| Date Received | 2017-01-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Brand Name | ALLODERM 18 X 16 |
| Generic Name | SURGICAL MESH |
| Product Code | OXH |
| Date Received | 2017-01-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 8 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-12 |