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

Catalog Number	UNKAA128
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per medwatch # mw5111923:- "the p4hb based mesh phasix has been used off-label, by a (b)(6) plastic surgeon for breast reconstruction in women with breast cancer, post-mastectomy.Unfortunately, p4hb materials can activate a pro-oncogenic immune response named the "m2 macrophage" response.Because p4hb activates m2 macrophages, its use in women with breast cancer patients is potentially dangerous.Additionally, introduction of any pro-inflammatory mesh product in a breast cancer resection space, could interfere with subsequent surveillance of cancer recurrences and, thus, lead to a life-threatening delay in diagnosis.Fda safety report id# (b)(4).
Additional Manufacturer Narrative
The allegation made, p4hb materials used in galaflex mesh activates a pro-oncogenic immune response (m2 macrophage) was submitted to fda by a former bd employee.No specific patient event was referenced in the medwatch report.A pro-oncogenic immune response is not a clinically anticipated outcome associated with use of p4hd mesh.Our review identified no increased concern that the use of p4hb mesh may cause nor otherwise influenced this condition/disease-related adverse event.Mdrs have been submitted in an abundance of caution by bdi surgery for reports of cancer recurrence associated with the indicated plastic surgeon in women with breast cancer, post-mastectomy.The surgeon did not identify any causal relationship between the cancer patient¿s experiencing recurrence and the galaflex implant used to treat the patients.Ref.Mdr: 1213643-2022-00597, 1213643-2022-00602, and 1213643-2022-00604.The date of event is provided as an estimate based on the date of awareness.

• 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: 15626630
• Report Number: 1213643-2022-00658
• Device Sequence Number: 18997117
• Product Code: OOD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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 Catalogue Number: UNKAA128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening
• Patient Sex: Female