MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX; BREAST - ABSORBABLE MESH

Catalog Number	GP0608
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Breast Cancer (1759)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed with breast cancer occurrence five years post-implant of galaflex.The surgeon did not identify any causal relationship between the cancer and the galaflex implant used to treat the patient.The surgeon's conclusion on this case considers that common breast cancers can develop in patients who have had absorbable mesh implants placed under the breast gland and on top of the chest wall muscles, and that these cancers can be detected, in their early stages, by common radiologic surveillance protocols.Review of manufacturing records confirms product was manufactured to specification.In an abundance of caution, events for which relatedness cannot be completely ruled out are processed for mdr reporting.The information provided by bd represents all of the known information at this time.
Event or Problem Description
On (b)(6) 2016 patient underwent internal and external mastopexy, lotus scaffold implant and autologous fat transfer to bilateral breasts from abdomen, hips and thighs.As reported galaflex 15.3cm x 20.3cm mesh was used to create the scaffold, treat the patient.On (b)(6) 2021, the patient was diagnosed with a left breast invasive ductal carcinoma.On (b)(6) 2021, the patient underwent bilateral nipple sparing mastectomy with immediate reconstruction with internal mastopexy and use of p4hb lotus with phasix mesh.Surgeon reports the patient is doing well and continues to follow up with cancer specialists and is on adjuvant endocrine therapy with anastrozole.Per the physician, the patient had a common breast carcinoma develop in her left breast gland (corpus mammae), on the inferior and lateral edge.The cancer was shown on pathologic exam under the microscope to be within the breast gland, which covered the nearby remnants of the mesh implant.There was no cancer cells within the mesh fibers or implant.The cancer was detected and diagnosed through annual radiologic surveillance.In the fall of 2021, the patient went for a mammogram that found some new calcifications in the left breast.An ultrasound of this breast was performed to investigate these calcifications.The calcifications turned out to be benign, but a nearby soft tissue mass was detected on the ultrasound.Needle biopsy made the diagnosis of invasive ductal carcinoma (9x13 mm).Pre-mastectomy mri showed this cancer was in the breast gland overlying the remnants of the mesh implant and not within the mesh.

• Brand Name: GALAFLEX
• Common Device Name: BREAST - ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15631404
• Report Number: 1213643-2022-00659
• Device Sequence Number: 12761689
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: GP0608
• Device Lot Number: 150154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 75 KG