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

Catalog Number	3341209G
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Cyst(s) (1800); Granuloma (1876); Deformity/ Disfigurement (2360)
Date of Event	11/07/2023
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.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.  this report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.  this report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.  if certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: breast cyst, granuloma, implant site calcification.  manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with 350cc mentor memoryshape breast implants.Post-operatively, the patient experienced a rupture of her left prosthesis, which was confirmed via ultrasound and complicated by granuloma formation in the left axilla.Small cysts were observed in the upper outer quadrant of the right breast and the retro areolar region of the left breast.It was also reported that the patient experienced implant site calcification of the left breast.As a result, the patient underwent bilateral removal and replacement with 355cc mentor memorygel boost breast implants on (b)(6) 2024.This report is for the left implant.Refer to manufacturing report number 1645337-2024-04362 for the contralateral event.
Additional Manufacturer Narrative
On april 24, 2024, mentor received the device for evaluation.On april 30, 2024, mentor completed a visual inspection and microscopic examination of the returned device.Device evaluation summary: visual analysis of the returned sample revealed that the breast implant was found to be ruptured, received in two (2) parts.Microscopic examination was performed and the cause of the tear could not be identified.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation but is more likely to occur the longer the implant is implanted.The following may cause implant to rupture: stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.Granulomas are noncancerous nodules that are a common tissue reaction to the presence of a variety of foreign materials, such as silicone.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).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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 03, 2024, mentor became aware that information was inadvertently omitted from the previous supplemental report.Manufacturer¿s reference number: (b)(4) in the previous report, h10 additional manufacturer narrative should have included the following information: 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.

• Brand Name: MENTOR MEMORYSHAPE 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19083840
• Report Number: 1645337-2024-04361
• Device Sequence Number: 8283402
• Product Code: FTR
• UDI-Device Identifier: 00081317005070
• UDI-Public: 00081317005070
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 07/16/2014
• Device Catalogue Number: 3341209G
• Device Lot Number: 5921098
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 05/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/03/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2009
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic