GalaFLEX 3D 100042-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810054980292), received between Apr 8, 2022 and Apr 12, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K161092); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  AS REPORTED PER PATIENT: ON (B)(6) 2023 PATIENT UNDERWENT BREAST REVISION SURGERY FOR A CAPSULAR CONTRACTION THAT WAS REMOVED AND WAS IMPLANTED WITH GALAFLEX 3D MESH. IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS POST IMPLANT PATIENT EXPERIENCED EXCRUCIATING PAIN AND PATIENT THOUGHT OF HAVING MUSCLE SPASMS. PATIENT VISITED THE SURGEON WHO THOUGHT SPASMS OF PECTORALIS MUSCLES MAY HAPPENING. IT WAS REPORTED THAT PATIENT WAS FEELING MESH HAS GATHERED UNDERNEATH THE BREAST IMPLANT AND PLANNING TO HAVE REVISION SURGERY ON (B)(6) 2024. IT WAS ALSO REPORTED THAT THE RIGHT BREAST IS THE SIDE THAT IS AFFECTED. PER MEDICAL RECORDS: ON (B)(6) 2023 PATIENT UNDERWENT BREAST IMPLANT REVISION/EXCHANGE WITH PLACEMENT OF GALAFLEX 3D, BREAST LIFT, FAT GRAFTING, LIPOSUCTION AND AVULSION BRACHIOPLASTY. PER OPERATIVE REPORT, "STARTED ON THE RIGHT BREAST. THE LATERAL BREAST POCKET WAS FOUND TO EXTEND LATERALLY INTO THE AXILLARY TISSUE DUE TO THE HEAVINESS OF THE PREVIOUS IMPLANTS. A LATERAL CAPSULORAPHY WAS PERFORMED IN ORDER TO CORRECT FUTURE LATERAL DISPLACEMENT OF THE IMPLANTS. A 365 FULL PROFILE SIZER WAS INSERTED. A GALAFLEX 3D MESH WAS PLACED TO PROVIDE SUPPORT FOR THE NEW RAISED IMF. THE MESH WAS SE

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 19095357 ↗
• InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BREAST REDUCTION SURGERY WITH SUSPENSION AND SCAFFOLD, LIPOSUCTION TO THE SUPRAPUBIC AREA ON (B)(6) 2022. AS REPORTED, GALAFLEX 3D MESH WAS IMPLANTED IN BILATERAL BREASTS WITH NO SUTURE ANCHORING. AS REPORTED, PATIENT STARTED TO EXPERIENCE ITCHING, SWELLING AND REDNESS BETWEEN THE NIPPLE AREOLA COMPLEX'S DOWN TO THE INFRAMAMMARY FOLD INCISIONS AND LATERALLY; ON (B)(6) 2022, PATIENT WAS PRESCRIBED KEFLEX ANTIBIOTICS FOR 2 WEEKS, INSTRUCTED TO TAKE BENADRYL THE NEXT DAY ((B)(6) 2022), VISIT THE ER. AS REPORTED, IT WAS NOTED THAT THE PATIENT'S LEFT BREAST REDNESS AND ITCHING HAD REDUCED. AS REPORTED, THE PATIENT WAS INSTRUCTED APPLY BACITRACIN TWICE DAILY TO THE AREOLA FOLLOWED BY XEROFORM AND WAS ASKED TO TAKE DOXYCYCLINE IF NEEDED, AFTER COMPLETION OF THE KEFLEX COURSE. AS REPORTED, THE PATIENT'S SYMPTOMS APPEARED TO BE IMPROVING AND WAS SENT HOME THE SAME EVENING.

  Patient problems: Erythema; Itching Sensation; Swelling/ Edema

  MAUDE report 14186894 ↗
• InjuryApr 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2020, PATIENT UNDERWENT BILATERAL REVISION RECONSTRUCTION USING AN IMF INCISION. THE PATIENT WAS HOSPITALIZED FOR THE PROCEDURE ON (B)(6) 2020 (DISCHARGED (B)(6) 2020). TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2020, LEFT BREAST SEROMA WAS REPORTED. ON (B)(6) 2020, PATIENT HAD SEROSANGUINOUS SEROMA FLUID DRAINAGE OF RIGHT BREAST SEROMA. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14057522 ↗
• InjuryApr 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON 6/9/20, PATIENT UNDERWENT BILATERAL REVISION RECONSTRUCTION USING AN IMF INCISION. THE PATIENT WAS HOSPITALIZED FOR THE PROCEDURE ON (B)(6) 2020 (DISCHARGED 6/10/20). 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2020, RIGHT BREAST INFECTION WAS REPORTED. ON (B)(6) 2020, PATIENT HAD WASH-OUT AND DEBRIDEMENT OF RIGHT BREAST. RIGHT BREAST IMPLANT AND NON ADHERENT MESH WAS EXPLANTED. RECONSTRUCTIVE SALVAGE WITH PLACEMENT OF NEW RIGHT IMPLANT (NO MESH). PATIENT ALSO RECEIVED MEDICATION (IV ANTIBIOTICS - NOT SPECIFIED WHICH IN RECORD). RESOLVED WITH SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED INFECTION AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Infection

  MAUDE report 14057494 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161092. One submission often covers many models, so check the product and lot details in each record.

• Z-0948-2017 · Nov 21, 2016 · Terminated
  GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce de