MAUDE Adverse Event Report: ALLERGAN SALES, LLC NATRELLE 133S TISSUE EXPANDER (RIGHT); TISSUE EXPANDER AND ACCESSORIES

Model Number	133S-FV-13-T
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 2022, i received double mastectomy surgery for left ductus carcinoma.The plastic surgeon did not communicate previous appointments, surgery informed consent did not state the information that i should no longer have mris or post-surgery appointments that i could not have an mri with the tissue expanders containing a magnetic/metal port that they use to help locate the port to put in iv fluid post-surgery and expand the tissue.(b)(6) 2022, i had the right breast tissue expander placed and not on the left.Next surgery for the left tissue expander surgery (b)(6) 2022 - no information was provided on any plastic surgery appointments prior to this surgery, on informed consent surgery form or post-surgery regarding the restriction of not having an mri completed.Asked by rn to sign a blank informed consent.I had multiple sclerosis (ms) prior to cancer and stated at my pre-surgery appointments that i had my ms medication halted with the potential of cancer secondarily to this (later noted not related to her 2+ cancer diagnosis).When i am not taking any ms medications, my neurologist prefers to have a brain mri completed every 6 months to monitor any progression in potential brain lesions increasing in size or new lesions forming.When i arrived for a brain mri ordered to be completed on march (b)(6) 2023, at (b)(6) hospital (b)(6).The mri technician caught this potential safety concern when i mentioned that i currently have two tissue expanders post-surgery following a double mastectomy and stated some of these expanders have metal/magnetic ports.My husband has a ph.D.In medical imaging as a physicist and noted when told of the same concern - he was present when i went for this appointment and spoke with the mri team.This technician stated she will research this and contact me after i have supplied my medical device information and she can confirm what is safe.I messaged my ms neurologist and noted the hold on getting the brain mri.I then received a message back via mychart that my tissue expanders had metal/magnetic and i would not be able to get an mri at this time.With concerns of my current plastic surgeon, i switched surgeons and post-covid - even for cancer patients there is a 6-12 month wait to have the saline breast implants of the reconstructive surgery using one's own tissue.This was previously not a concern of using metal in tissue expanders pre-covid with the ability to have them removed in 8 weeks.Without the ability to have a brain mri, this also eliminated the opportunity to have an mri if there was a potential of cancer returning.The highest risk of this is within one year of the initial cancer and i had a breast mri prior to my first surgery for this reason - to make sure it had not spread and a better image than the ultrasound used in a biopsy.Two poor health outcomes - 1) inability to monitor my ms with the appropriate tesla imaging using flair and t2-weighted mri knowing that any progression is permanent and can lead to a variety of disabilities and 2) the inability to monitor my cancer recurring.When i felt scar tissue forming i was told i cannot have a biopsy without surgery with the risk of puncturing the expanders and i cannot have an mri.The only monitoring was with an ultrasound device that is a toddler level of imaging compared to an mri.Main concerns reviewing the cdc breast cancer and up-to-date data there is a high mortality rate for black women is twice as high compared caucasians, although the incident rate is similar - needs changed to monitor for cancer recurring mri tissue expanders with metal/magnetic need a new fda policy that notes that all cancer patients need tissue expanders used that are non-magnetic/non-metallic.They are being made.Personally the fda needs to eliminate all tissue expanders with metal as in my situation, a patient may have a secondary medical condition that needs monitoring via mri.Unable to load a copy of both tissue expanders below.Lot number: rh238198015.Reference report: mw5117620.

• Brand Name: NATRELLE 133S TISSUE EXPANDER (RIGHT)
• Common Device Name: TISSUE EXPANDER AND ACCESSORIES
• Manufacturer (Section D): ALLERGAN SALES, LLC
• MDR Report Key: 16952647
• Report Number: MW5117619
• Device Sequence Number: 6286661
• Product Code: LCJ
• UDI-Device Identifier: 10888628043794
• UDI-Public: 10888628043794
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 133S-FV-13-T
• Device Catalogue Number: 133S-FV-13-T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPHETAMINE-DEXTROAMPHETAMINE 20 MG 24 HR CAPSULE (XR), AND 5 MG QUICK RELEASE ADDERALL, LASIX 20 MG BID, POTASSIUM CHLORIDE 20 MEQ ER, ODANSETRON 4 MG PRN, HYDROXYZINE 25 MG PRN, RIZITRIPTAN 10 MG PRN, GLATIRAMER 40 MG/ML PREFILLED (MS MED ON HOLD), ABBVIE ALLERGAN LIFE CELL ALLODERM SELECT ACELLULAR MATRIX CONTOUR.; K2 PO, ACETYLCARNITINE HCL 500 MG CAP, ASPIRIN 81 MG TABLET, NAC (N-ACETYLCYSTEINE) 600 MG, RIBOFLAVIN 400 MG, ASCORBIC ACID WITH ROSE HIPS (VITAMIN C) 1000 MG, CALCIUM ASCORBATE 500 MG, TYLENOL 500 MG PRN, VITAMIN D3 5,000 UNITS, MAGNESOIM 200 MG.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White