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

Model Number	3542007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Code Available (3191); Cancer (3262)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: breast cancer and rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a primary breast reconstruction with mentor memorygel breast implants (300cc on the left side; 200cc on the right side).The patient reported that she was diagnosed with right-sided breast cancer on (b)(6) 2020.She stated that she would have to go into radiation but her physician does not believe that her implants could handle the treatment.She also stated that an mri on (b)(6) 2020 confirmed bilateral intracapsular rupture.As a result, the patient's devices were scheduled for removal on (b)(6) 2020.This report is for the patient's right-sided device.
Additional Manufacturer Narrative
Additional information: on may 4, 2020, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: on june 5, 2020, mentor became aware that the patient also experienced calcification on the right side.As a result, the patient underwent a core biopsy on the right side.On june 12, 2020, the product investigation was updated.Updated device investigation summary: during the visual evaluation of the device, a delamination with leaks was observed at the union between shell and patch.Calcification and breast imaging calcification of a biomaterial occurs when calcium salts are deposited in the tissue capsule surrounding the implanted device.Calcification occurs in association with a wide variety of implanted prostheses, including breast implants, heart valves, vascular grafts, and soft contact lenses, as well as in the mature breast tissue of women that have not undergone breast surgery.Calcification of the fibrous capsule that may occur following implantation of breast prostheses is generally not of clinical significance, although it may exacerbate symptoms of capsular contracture.Concern has been raised, however; that calcification may interfere with tumor detection, because microcalcifications are considered a halfmark of malignant breast disease.Although clinicians have recommended pre- and post-surgical mammograms for augmentation patients to assist in distinguishing post-operative findings from calcification associated with malignancy, benign calcification resulting from surgery is generally considered distinguishable from malignant-type calcification.Further, no published reports were identified that document any actual occurrences of missed or delayed diagnoses attributable to capsular calcification.Calcification is not a phenomenon unique to breast implants.It occurs in 11 to 53 percent of women who underwent breast reduction procedures (abboud et aj.1995, m&nick et al.1990, brown et al.1987).In the breasts of women who have not undergone any breast surgery, the prevalence of benign calcifications increases progressively with age from 8 percent in women 25 to 29 years old up to 86 percent in women 75 to 79 years old (stomper et al.1996).Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.This report is for the patient's right-sided device.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On may 13, 2020, the product investigation was completed.Device investigation summary: during visual evaluation of the device, a delamination with leaks was observed at the union between shell and patch.A manufacturing record evaluation for the complaint device could not be performed, since the physical record could not be located.An internal corrective action has been opened to address this issue.If the physical record is located, a manufacturing record evaluation will be performed, and a supplemental report will be submitted.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).

• 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
• MDR Report Key: 9908401
• Report Number: 1645337-2020-04175
• Device Sequence Number: 11448522
• Product Code: FTR
• UDI-Device Identifier: 00081317000631
• UDI-Public: 00081317000631
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/11/2020

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 Model Number: 3542007
• Device Catalogue Number: 3542007
• Device Lot Number: 29827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 05/13/2020; 06/05/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 05/04/2020; 05/14/2020; 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR