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

Model Number	100035-14
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Breast Discomfort/Pain (4504)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.Photo evaluation finds the explanted breast implant, however galaflex cannot be identified in the photo.As the galaflex was implanted approximately 33 months ago it is unlikely that the mesh was still present at the time of breast implant explant procedure.Per ifu, "bioresorption of the scaffold material will be essentially complete within 18-24 months." pain is a known inherent risk of surgery and was identified as possible complication in the adverse reactions section of the instructions-for-use, supplied with the device.Based on the information provided, no conclusions can be made the degree to which the device may be causing or contributing the patient¿s reported symptoms.A review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this lot of (b)(4) units.Note, the date of implant ((b)(6) 2022), date of event and device explant date ((b)(6) 2024) are considered to be a best estimate.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, following breast implant surgery in 2020, the patient underwent implant of galaflex and replacement of breast implants with smaller ones in (b)(6) 2022.It was reported that post implant of galaflex, patient had pain, developed "iron breast syndrome" and also a "lump" on the right lateral breast.It was also reported that during last week, the patient underwent removal of the "wadded up galaflex".
Event or Problem Description
As reported, following breast implant surgery in 2020, the patient underwent implant of galaflex and replacement of breast implants with smaller ones in (b)(6) 2022.It was reported that post implant of galaflex, patient had pain, developed "iron breast syndrome" and also a "lump" on the right lateral breast.It was also reported that during last week, the patient underwent removal of the "wadded up galaflex".Addendum: it was additionally reported that the explanting surgeon told the patient that "it was sure what removed was balled up galaflex and did not believe the product had been placed correctly.".
Additional Manufacturer Narrative
As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.Photo evaluation finds the explanted breast implant, however galaflex cannot be identified in the photo.As the galaflex was implanted approximately 33 months ago it is unlikely that the mesh was still present at the time of breast implant explant procedure.Per ifu, "bioresorption of the scaffold material will be essentially complete within 18-24 months." pain is a known inherent risk of surgery and was identified as possible complication in the adverse reactions section of the instructions-for-use, supplied with the device.Based on the information provided, no conclusions can be made the degree to which the device may be causing or contributing the patient¿s reported symptoms.A review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this lot of (b)(4) units.Note, the date of implant (b)(6) 2022, date of event and device explant date (b)(6) 2024 are considered to be a best estimate.Addendum: this supplemental mdr is submitted to document the additional information provided and the video evaluation results.As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.A video was provided of the surgeon examining the explanted silicone breast implants removed during a procedure he performed.In the video the surgeon identifies that the patient has been in pain since her last implant surgery which was 4 years ago.He also states that there was a palpable material in her right breast.While showing the capsulated implants he identifies the area in the capsule of the right implant that contains what he thinks could be a drain.While dissecting the capsule around the implant the surgeon removes the material and identifies what he describes as remnants of a plastic or silicone surgical drain that was used in the prior surgery 4 years ago.He also finds remnants of the same material in the left implant.There is no galaflex observed or mentioned.Based on the video and surgeon statements it can be concluded that the galaflex mesh did not cause the post operative pain and complications.Updated fields: b4, b5, e1, g3, g6, h2, h6, h10 note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, following breast implant surgery in 2020, the patient underwent implant of galaflex and replacement of breast implants with smaller ones in (b)(6) 2022.It was reported that post implant of galaflex, patient had pain, developed "iron breast syndrome" and also a "lump" on the right lateral breast.It was also reported that during last week, the patient underwent removal of the "wadded up galaflex".Addendum: it was additionally reported that the explanting surgeon told the patient that "it was sure what removed was balled up galaflex and did not believe the product had been placed correctly." addendum per information provided by contact: it was reported that the galaflex mesh was implanted in (b)(6) 2023.Patient also reported that the "surgeon saying that he believed the matter he found was ¿degrading tubing¿, after that he came to talk to her and had changed his mind and believed it was gf (galaflex) due to the ¿honeycomb¿ design.".
Additional Manufacturer Narrative
As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.Photo evaluation finds the explanted breast implant, however galaflex cannot be identified in the photo.As the galaflex was implanted approximately 33 months ago it is unlikely that the mesh was still present at the time of breast implant explant procedure.Per ifu, "bioresorption of the scaffold material will be essentially complete within 18-24 months." pain is a known inherent risk of surgery and was identified as possible complication in the adverse reactions section of the instructions-for-use, supplied with the device.Based on the information provided, no conclusions can be made the degree to which the device may be causing or contributing the patient¿s reported symptoms.A review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this lot of (b)(4) units.Addendum #1: this supplemental mdr is submitted to document the additional information provided and the video evaluation results.As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.A video was provided of the surgeon examining the explanted silicone breast implants removed during a procedure he performed.In the video the surgeon identifies that the patient has been in pain since her last implant surgery which was 4 years ago.He also states that there was a palpable material in her right breast.While showing the capsulated implants he identifies the area in the capsule of the right implant that contains what he thinks could be a drain.While dissecting the capsule around the implant the surgeon removes the material and identifies what he describes as remnants of a plastic or silicone surgical drain that was used in the prior surgery 4 years ago.He also finds remnants of the same material in the left implant.There is no galaflex observed or mentioned.Based on the video and surgeon statements it can be concluded that the galaflex mesh did not cause the post operative pain and complications.Addendum #2: h11: this supplemental mdr is submitted to document the additional information provided and to correct the implant date.Note, the date of implant ((b)(6)2023), date of event and device explant date ((b)(6)2024) are considered to be a best estimate.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.Photo evaluation finds the explanted breast implant, however galaflex cannot be identified in the photo.As the galaflex was implanted approximately 33 months ago it is unlikely that the mesh was still present at the time of breast implant explant procedure.Per ifu, "bioresorption of the scaffold material will be essentially complete within 18-24 months." pain is a known inherent risk of surgery and was identified as possible complication in the adverse reactions section of the instructions-for-use, supplied with the device.Based on the information provided, no conclusions can be made the degree to which the device may be causing or contributing the patient¿s reported symptoms.A review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this lot of 297 units.Addendum #1: this supplemental mdr is submitted to document the additional information provided and the video evaluation results.As reported, patient had pain, iron breast syndrome, mesh deformation post implant of galaflex and got explanted.A video was provided of the surgeon examining the explanted silicone breast implants removed during a procedure he performed.In the video the surgeon identifies that the patient has been in pain since her last implant surgery which was 4 years ago.He also states that there was a palpable material in her right breast.While showing the capsulated implants he identifies the area in the capsule of the right implant that contains what he thinks could be a drain.While dissecting the capsule around the implant the surgeon removes the material and identifies what he describes as remnants of a plastic or silicone surgical drain that was used in the prior surgery 4 years ago.He also finds remnants of the same material in the left implant.There is no galaflex observed or mentioned.Based on the video and surgeon statements it can be concluded that the galaflex mesh did not cause the post operative pain and complications.Addendum #2: h11: this supplemental mdr is submitted to document the additional information provided and to correct the implant date.Addendum #3: h11: this supplemental mdr is submitted to document the additional information provided and to correct the explant date.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, following breast implant surgery in 2020, the patient underwent implant of galaflex and replacement of breast implants with smaller ones in (b)(6) 2022.It was reported that post implant of galaflex, patient had pain, developed "iron breast syndrome" and also a "lump" on the right lateral breast.It was also reported that during last week, the patient underwent removal of the "wadded up galaflex".Addendum: it was additionally reported that the explanting surgeon told the patient that "it was sure what removed was balled up galaflex and did not believe the product had been placed correctly." addendum per information provided by contact: it was reported that the galaflex mesh was implanted in (b)(6) 2023.Patient also reported that the "surgeon saying that he believed the matter he found was ¿degrading tubing¿, after that he came to talk to her and had changed his mind and believed it was gf (galaflex) due to the ¿honeycomb¿ design." addendum per explant operative report: it was reported that the patient underwent capsulectomy, bilateral implant removal, bilateral muscle repair, bilateral mini mastopexy on (b)(6)2024.It was noted during the explantation that there was an additional capsule with a foreign object attached to the inferior extent of the implant capsule and this was removed along with the breast implant and capsule.Encapsulated piece of mesh removed and noted fused to capsule of both breast implants.Right side and left side mesh retrieved were folded upon itself.

• Brand Name: GALAFLEX
• Common Device Name: 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: 20925148
• Report Number: 1213643-2024-00581
• Device Sequence Number: 12051765
• Product Code: OOD
• UDI-Device Identifier: 00855920006027
• UDI-Public: (01)00855920006027(17)240731(10)LXGX0034
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2025

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: 07/31/2024
• Device Model Number: 100035-14
• Device Catalogue Number: GP0208
• Device Lot Number: LXGX0034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 12/31/2024; 01/23/2025; 02/07/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/30/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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: 48 YR
• Patient Sex: Female