MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number 3501655

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Fatigue (1849); Pain (1994); No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

The product investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. The device history record (dhr) of lot number 5547192 was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

Event Description

It is reported that a patient had both mentor implants sal smooth rnd diap 350cc (catalog#3501655; lot# : 5547192-088) removed due to severe nipple pain, body was rejecting implants. Patient kept implants. Patient had implants in for 10 yrs. Mold was reported in the valve and on the outside of the implant. Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation.

Manufacturer Narrative

In the initial report, medwatch # 1645337-2017-00062 submitted 8/18/2017, it was mistakenly stated that the device had been returned to mentor, and that the investigation was in progress. However, the device was not actually returned. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. As such, the investigation will be closed. If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate. The device history record (dhr) was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

Event Description

It was reported that a (b)(6) female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. The patient underwent explantation procedure on (b)(6) 2016. It was reported that the inside of the valve and the outside of the implant had mold. The implants were intact upon explantation. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation.

Manufacturer Narrative

Device evaluation summary: it was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor saline smooth round moderate profile implants 350cc (catalog # 3501655) reported multiple symptoms that began right after implantation. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. The patient underwent explantation procedure in (b)(6) 2016. It was reported that the inside of the valve and the outside of the implant had mold. The implants were intact upon explantation. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made. The manufacturing record evaluation (mre) of lot number 5547192 was reviewed and no anomalies were found related to this complaint. The mre review verifies that the device was manufactured in accordance with documented specification and procedures. No anomalies were identified which would result in foreign matter on device, specifically the valve and shell surface. The product was within specification and was manufactured and sterilized in accordance with procedures. Manufacturing controls: the manufacturing process (from shell fabrication to secondary packaging) was reviewed for foreign matter/ particulate control at mentor irving cmes (controlled manufacturing environment) which includes shell fabrication, main assembly, primary packaging areas, gamma sterilization, and secondary packaging areas. At multiple points of the manufacturing process, devices within the lot are processed to ensure any foreign matter, particulates or contaminants are removed or 100% visually inspected for any defects including foreign matter or particulates and subsequently rejected when identified. All manufacturing areas where the shell or device is exposed to environment is a controlled manufacturing environment (cme). Gowning is required and strictly enforced for all individuals entering designated controlled manufacturing environments (cme) at mentor, whether they are mentor employees, visitors or contractors. The cme garments consist of hair coverings (bouffant and/or hood), frock or jumpsuit, and shoe or boot covers. Sterilization records were also reviewed for product code 3501655, lot# 5547192. Environmental monitoring for viable airborne particulates and surface microbials is routinely performed in each controlled manufacturing environment (cme) on a weekly basis. Review of the environmental monitoring data for viable airborne particulates and surface microbials during the manufacturing of product code 3501655, lot# 5547192 identified all acceptable results in order to release the lot. Non-viable particulates are measured on a quarterly basis. Review of the non-viable particulates data for q204 and q304 (periods before and after the manufacture of product code 3501655, lot# 5547192) were reviewed and no excursions were identified. In addition, per (b)(4) ¿mentor medical assessments for complaints revision 1, a root cause failure analysis will not be conducted since the investigation could not confirm that an actual failure of the device to conform to expected performance had occurred. Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant. Infection is a known complication associated with any surgery. The application failure modes and effects analysis (afmea) was reviewed for the defect in question (foreign matter/mold) with the severity being determined to be as low as possible, with no further action required. If the complaint device is received in the future, the complaint will be re-opened and additional investigation will be completed. Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038 3540
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038 3540
• Manufacturer Contact: joaquin kurz ; 3041 skyway circle north; irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6819169
• Report Number: 1645337-2017-00062
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/29/2008
• Device Catalogue Number: 3501655
• Device Lot Number: 5547192
• Other Device ID Number: 3501655
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 43 YR
• Patient Outcome(s): Required Intervention