Strattice Reconstructive Tissue Matrix BPS 0808006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M32808080060), received between Apr 1, 2019 and Jan 17, 2020 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANT EXCHANGE SURGERY AND WAS IMPLANTED WITH ALLERGAN BREAST IMPLANTS AND STRATTICE ON (B)(6) 2018. ALMOST ONE YEAR LATER, PATIENT PRESENTED WITH A SPONTANEOUS EXPOSED LEFT BREAST IMPLANT. THEY ENDED UP IN THE ER, LABS WERE DRAWN AND A CULTURE WAS TAKEN OF THE ABSCESS FLUID ON THE RIGHT BREAST. THEY WERE PUT ON ANTIBIOTICS AND WITHIN 24 HOURS, THEIR INCISION STARTED TO OPEN UP. THEIR IMPLANT AND UNINCORPORATED STRATTICE WAS EXPOSED. A SURGEON IDENTIFIED THE STRATTICE AND REMOVED THE EXPOSED STRIPS, AND PATIENT'S RIGHT SIDE IMPLANT WAS REMOVED ABOUT A WEEK LATER. TWO DAYS AFTER THE REMOVAL OF THE IMPLANT, A LEFT ABSCESS APPEARED, AND THE IMPLANT WAS REMOVED. PATIENT HAD DRAINS PLACED AND IMMEDIATELY STARTED TO DISCHARGE A THICK, GREEN MUCOUS. ALL CULTURES FROM DRAINAGE AND TISSUE AND ALL BLOOD TESTS SHOWED NO BACTERIA, NO FUNGUS, NO INFLAMMATORY MARKERS. THEIR INCISIONS STARTED TO OPEN AGAIN AND ANOTHER HOLE FORMED ON THEIR RIGHT BREAST AND DEALT WITH EXTREME DISCHARGE. BREAST IMPLANTS AND ANY LEFTOVER ADM WERE REMOVED. AFTER SURGERY, THE GREEN DISCHARGED STOPPED. THE RIGHT BREAST HEALED, AND THE LEFT BREAST HAD CELLULITIS. PATIENT WAS

  Patient problems: Cellulitis; Discharge; Foreign Body Reaction

  MAUDE report 9602513 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANT EXCHANGE SURGERY AND WAS IMPLANTED WITH ALLERGAN BREAST IMPLANTS AND STRATTICE ON (B)(6) 2018. ALMOST ONE YEAR LATER, PATIENT PRESENTED WITH A SPONTANEOUS EXPOSED RIGHT BREAST IMPLANT WITH AN ABSCESS. THEY ENDED UP IN THE ER, LABS WERE DRAWN AND A CULTURE WAS TAKEN OF THE ABSCESS FLUID ON THE RIGHT BREAST. THEY WERE PUT ON ANTIBIOTICS AND WITHIN 24 HOURS, THEIR INCISION STARTED TO OPEN UP. THEIR IMPLANT AND UNINCORPORATED STRATTICE WAS EXPOSED. A SURGEON IDENTIFIED THE STRATTICE AND REMOVED THE EXPOSED STRIPS, AND PATIENT'S RIGHT SIDE IMPLANT WAS REMOVED ABOUT A WEEK LATER. TWO DAYS AFTER THE REMOVAL OF THE IMPLANT, A LEFT ABSCESS APPEARED, AND THE IMPLANT WAS REMOVED. PATIENT HAD DRAINS PLACED AND IMMEDIATELY STARTED TO DISCHARGE A THICK, GREEN MUCOUS. ALL CULTURES FROM DRAINAGE AND TISSUE AND ALL BLOOD TESTS SHOWED NO BACTERIA, NO FUNGUS, NO INFLAMMATORY MARKERS. THEIR INCISIONS STARTED TO OPEN AGAIN AND ANOTHER HOLE FORMED ON THEIR RIGHT BREAST AND DEALT WITH EXTREME DISCHARGE. BREAST IMPLANTS AND ANY LEFTOVER ADM WERE REMOVED. AFTER SURGERY, THE GREEN DISCHARGED STOPPED. THE RIGHT BREAST HEALED, AND THE LEFT BREAST HAD CELLULI

  Patient problems: Cellulitis; Discharge; Foreign Body Reaction

  MAUDE report 9602504 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT THEY WERE IMPLANTED WITH 3 STRATTICE BPS DEVICES (LOT #S: SP100540-482, SP100528-238, & SP100519-009) ON (B)(6) 2018. SOMETIME IN (B)(6) 2018, THE PATIENT BEGAN TO EXPERIENCE "PAIN, ITCHING, AND SKIN RASHES" WHERE THE PRODUCT IS IMPLANTED. THE PATIENT ADVISED THEY ARE NOW SEEKING TO HAVE THE IMPLANTS REMOVED. THIS COMPLAINT IS ASSOCIATED WITH THE SECOND OF THREE DEVICES IMPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE STRATTICE DEVICES WERE ALL EXPLANTED ON (B)(6) 2019. THE PATIENT HAS NO KNOWN ALLERGY TO PORCINE OR POLYSORBATE 20.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8471440 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT THEY WERE IMPLANTED WITH 3 STRATTICE BPS DEVICES (LOT #S: SP100540-482, SP100528-238, & SP100519-009) ON (B)(6) 2018. SOMETIME IN (B)(6) 2018, THE PATIENT BEGAN TO EXPERIENCE "PAIN, ITCHING, AND SKIN RASHES" WHERE THE PRODUCT IS IMPLANTED. THE PATIENT ADVISED THEY ARE NOW SEEKING TO HAVE THE IMPLANTS REMOVED. THIS COMPLAINT IS ASSOCIATED WITH THE FIRST OF THREE DEVICES IMPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE STRATTICE DEVICES WERE ALL EXPLANTED ON (B)(6) 2019. THE PATIENT HAS NO KNOWN ALLERGY TO PORCINE OR POLYSORBATE 20.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8471439 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT THEY WERE IMPLANTED WITH 3 STRATTICE BPS DEVICES (LOT #S: SP100540-482, SP100528-238, & SP100519-009) ON (B)(6) 2018. SOMETIME IN (B)(6) 2018, THE PATIENT BEGAN TO EXPERIENCE "PAIN, ITCHING, AND SKIN RASHES" WHERE THE PRODUCT IS IMPLANTED. THE PATIENT ADVISED THEY ARE NOW SEEKING TO HAVE THE IMPLANTS REMOVED. THIS COMPLAINT IS ASSOCIATED WITH THE THIRD OF THREE DEVICES IMPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE STRATTICE DEVICES WERE ALL EXPLANTED ON (B)(6) 2019. THE PATIENT HAS NO KNOWN ALLERGY TO PORCINE OR POLYSORBATE 20.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8471437 ↗