MAUDE Adverse Event Report: TEPHA, INC GALAFLEX; SURGICAL MESH

Model Number	CE0408
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Capsular Contracture (1761); Patient Problem/Medical Problem (2688)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was used in (b)(6) (ce616166) and is equivalent to a us device gp0408 (k140533).The device history records were reviewed and indicated that the product met all acceptance criteria.Product was sterilized per validated parameters.The patient had a history of developing a capsule around the breast implant as a result of the original surgery performed in 2008.The physician also reported that the original left breast implant was ruptured.In the subsequent surgery performed in late 2019 to replace the allergan breast implants with motiva breast implants the galaflex scaffold was used to provide support.The physician cut the galaflex device in a manner that is not commonly performed on the scaffold and inconsistent with the product instructions for use.Based on the placement of the device it is inconclusive if the device caused or contributed to the adverse event.In the most recent revision surgery ((b)(6) 2020) as a result of the patients' complaint about pain in the breast and the recurrent capsular contracture, the physician removed the galaflex scaffold and the capsule tissue for analysis.The explant has been sent to a laboratory for histopathology to provide further understanding of the situation.
Event or Problem Description
Patient was originally operated on in 2008 and was implanted with allergan style 410 fm 395 breast implants.During 2019 she started developing firm breast and severe capsule contraction in the left breast (grade iv) and in her right breast (grade ii).In (b)(6) 2019 her physician performed a bilateral total capsulectomy.The original left breast implant was ruptured and there was some brownish fluid around the implant.The capsule tissues from both breasts were sent for alcl testing, both were negative.The physician stated he then performed an implant change using motiva ersm-500 q breast implants and using the galaflex scaffold to support the implants in a "hammock design" covering half of the implant in the lower pole and lower posterior site.The implants and galaflex were soaked in double solution antibiotics.Within approximately 3 months post-op the patient started to develop firm breast grade iv bilaterally.On (b)(6) 2020, the physician performed revision surgery and observed that both breasts had extremely thick capsulae (around 1 cm thick and rubberlike) where the galaflex had been set, especially the right breast.The galaflex scaffold was explanted.
Event or Problem Description
Patient was originally operated on in 2008 and was implanted with allergan style 410 fm 395 breast implants.During 2019 she started developing firm breast and severe capsule contraction in the left breast (grade iv) and in her right breast (grade ii).In (b)(6) 2019 her physician performed a bilateral total capsulectomy.The original left breast implant was ruptured and there was some brownish fluid around the implant.The capsule tissues from both breasts were sent for alcl testing, both were negative.The physician stated he then performed an implant change using motiva ersm-500 q breast implants and using the galaflex scaffold to support the implants in a "hammock design" covering half of the implant in the lower pole and lower posterior site.The implants and galaflex were soaked in double solution antibiotics.Within approximately 3 months post-op the patient started to develop firm breast grade iv bilaterally.On (b)(6) 2020, the physician performed revision surgery and observed that both breasts had extremely thick capsulae (around 1 cm thick and rubberlike) where the galaflex had been set, especially the right breast.The galaflex scaffold was explanted.
Additional Manufacturer Narrative
Product was used in (b)(6) (ce616166) and is equivalent to a us device gp0408 (k140533).The device history records were reviewed and indicated that the product met all acceptance criteria.Product was sterilized per validated parameters.The patient had a history of developing a capsule around the breast implant as a result of the original surgery performed in 2008.The physician also reported that the original left breast implant was ruptured.In the subsequent surgery performed in late 2019 to replace the allergan breast implants with motiva breast implants the galaflex scaffold was used to provide support.The physician cut the galaflex device in a manner that is not commonly performed on the scaffold and inconsistent with the product instructions for use.Based on the placement of the device it is inconclusive if the device caused or contributed to the adverse event.In the most recent revision surgery ((b)(6) 2020) as a result of the patients' complaint about pain in the breast and the recurrent capsular contracture, the physician removed the galaflex scaffold and the capsule tissue for analysis.The explant has been sent to a laboratory for histopathology to provide further understanding of the situation.Follow-up information: the histopathology analysis, performed on the explanted tissue provided by the physician, has been completed.While the data are not conclusive, the histology results show that the tissue response to the galaflex scaffold was moderate, with moderate deposition of fibrous connective tissue, minimal inflammation, and no evidence of adverse pathology.However, there were thicker areas within the samples that demonstrated increased smooth muscle actin (sma), and contained multiple layers of mesh material, while there were also thinner areas that showed minimal/more typical smooth muscle actin, and contained a single to double layer of mesh material.Sma is a contractile protein expressed within smooth muscles, vascular smooth muscle cells and myofibroblasts.It is normally produced by myofibroblasts during wound healing and functions to contract the wound.It also probably plays a role in capsular contraction.The pattern of expression in the samples suggests that the mesh alone does not seem to be instigating sma expression.In the histology samples, the sma staining is robust in the capsule and extends into the mesh.It is theorized that enhanced smooth muscle actin expression in the thick areas may have served to gather the mesh, which had been fenestrated and minimally anchored at implantation, and led to the significant bunching seen in those areas.Fibroblasts (fb) are part of the normal healing response, and they infiltrate the newly formed tissue within the mesh.If the mesh were the causative agent of the contraction and bunching, the fbs present throughout the mesh as part of the normal healing process would change phenotype, express sma and contract.But this is not happening, as evidenced by other areas in the tissue containing multiple layers of mesh that are not staining strongly for sma.In addition to the histology staining results, the mesh fibers were interpreted as largely intact but with some evidence of bioresorption, and complete infiltration/integration by the host tissue response, as expected for this time point.

• Brand Name: GALAFLEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TEPHA, INC; 99 hayden ave; lexington, ma
• MDR Report Key: 9771948
• Report Number: 3005670760-2020-00001
• Device Sequence Number: 12377135
• Product Code: OOD
• Combination Product (Y/N): N
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CE0408
• Device Catalogue Number: 100035-36
• Device Lot Number: 190008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOTIVA ERSM-500 Q BREAST IMPLANTS.; MOTIVA ERSM-500 Q BREAST IMPLANTS.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR