MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3543607MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Capsular Contracture (1761); Cyst(s) (1800)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient underwent primary breast augmentation with a (left) 375cc mentor memorygel breast implant and a (right) 360cc mentor memorygel breast implant.Post-operatively, the patient self-diagnosed a left breast lump and a right breast cyst.As a result, the patient underwent a series of examinations.Ultrasound found microcalcifications on both breasts, and nodules in the left breast which were reported to be possible silicone in the left axillary lymph nodes.There is also suspicion of bilateral breast implant ruptures.The patient underwent excision of the mass from the left axilla.Pathology showed presence of silicone material within the axillary lymph nodes but there is no evidence of malignancy.There is however evidence of enlargement of chronic inflammatory reaction occurring in the axillary area.The patient was also diagnosed with bilateral breast ptosis.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2022, mentor received additional information indicating that the patient has been scheduled for bilateral implant removal on (b)(6) 2022.Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Reason for device explant and/or reoperation: breast cyst, implant site calcification, material rupture.
Additional Manufacturer Narrative
On (b)(6) 2022, mentor became aware that the patient was also diagnosed with bilateral breast ptosis (grade 3), bilateral breast capsular contractures (baker grade unknown), and bilateral double bubble deformity.The patient underwent bilateral capsulectomies, and bilateral biopsies.The patient's implants were replaced with the following: (left) 650cc mentor memorygel breast implant catalog: shpx650 lot: 9639098 sn: (b)(6) and (right) 650cc mentor memorygel breast implant catalog: shpx650 lot: 9639098 sn: (b)(6).This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On march 14, 2022, the mentor failure analysis lab received the device for evaluation.On march 29, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that the sx mod classic gel, 360cc breast implant had parallel lines of shell wear on the posterior aspect.Additionally a tear was noted within the shell wear, measuring approximately 1.6 cm.The evaluation determined that the cause of the rupture is consistent with normal wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.A breast cyst is a fluid-filled sac within the breast.One breast can have one or more breast cysts.They are often described as round or oval lumps with distinct edges.Breast cysts are usually and typically do not require treatment, but they can be drained using fine needle aspiration if the cyst is large or uncomfortable.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13232465
• Report Number: 1645337-2022-00351
• Device Sequence Number: 4610212
• Product Code: FTR
• UDI-Device Identifier: 00081317004424
• UDI-Public: 00081317004424
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 3543607MC
• Device Catalogue Number: 3543607MC
• Device Lot Number: 6823244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 02/04/2022; 03/03/2022; 03/14/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/26/2022; 03/08/2022; 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White