Strattice Reconstructive Tissue Matrix BPS CON1006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M328CON10060), received between Apr 9, 2019 and Jan 20, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 20, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA MEDICAL INFORMATION THAT A PATIENT IMPLANTED WITH BREAST IMPLANTS AND STRATTICE DEVELOPED A SECOND CAPSULAR CONTRACTURE IN BOTH BREASTS AND HIGHER THAN THE LEFT. THIS RECORD REPRESENTS THE RIGHT SIDE STRATTICE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE 3 CAP CON RIGHT BREAST." THIS RECORD REPRESENTS 1 OF 2 STRATTICE DEVICES.

  Patient problems: Capsular Contracture

  MAUDE report 24122577 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED FROM THE SALES REP ON BEHALF OF THE HCP THAT STRATTICE DEVICE LOT WAS (B)(4), CON1006 WAS EXPLANTED, MAY HAVE BEEN IN AUGUST. THE SALES REP WAS UNSURE IF IT WAS AN INFECTION. NO OTHER INFORMATION WAS PROVIDED. THE COMPLAINT RELATED DEVICE WAS DISCARDED. CLARIFICATION WAS RECEIVED THAT THE LOT ASSOCIATED WITH THIS EVENT IS SP200131-304. UPDATED INFORMATION WAS RECEIVED ON 10/JAN/2023, THAT THE STRATTICE WAS IMPLANTED ON (B)(6) 2020. THE L DRAIN AND MORE DRAINAGE THAN THE R AND THE L DRAIN WAS REMOVED (B)(6) 2020. AFTER THE DRAIN REMOVAL THE PATIENT HAD INTERMITTENT DRAINAGE FROM THE L BREAST FROM (B)(6) 2020 TO (B)(6) 2021. THE L BREAST WAS SWOLLEN AND TENDER. THE IMPLANT WAS REMOVED ON (B)(6) 2021 AND PATHOLOGY OF THE STRATTICE WAS TAKEN. THE HCP DOES BELIEVE THE INFECTION WAS DUE TO THE STRATTICE.

  Patient problems: Bacterial Infection

  MAUDE report 16151932 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT HAD BLISTER LIKE SORES FILLED WITH PUSS WITHIN A COUPLE DAYS/WEEK OF HER SURGERY. PATIENT INITIALLY THOUGHT IT WAS A BUG BIT BUT THEN SPREAD TO BOTH BREASTS. PATIENT WENT TO INFECTIOUS DISEASE AND WAS PUT ON ANTIBIOTICS BUT ISSUE DID NOT RESOLVE. HEALTHCARE PROFESSIONAL TOOK HER BACK TO THE OPERATING ROOM ON (B)(6) 2020 AND DID A POCKET EXAM. STRATTICE WAS WELL INCORPORATED AND NO SIGN OF FLUID AROUND THE IMPLANT. PATIENT SAW A DERMATOLOGIST TODAY AND THE DERMATOLOGIST FEELS IT MAY BE AN ¿ALLERGY TO ADM¿. A MEDICAL EXAM WAS PERFORMED BY PATIENT'S PRIMARY PROVIDER. CHIEF COMPLAINTS NOTED TO BE: "LICHEN SCLEROSUS ET ATROPHICUS" (LSA), AND "GRANULOMATOUS DERMATITIS". "STRATTICE MESH SUSPECTED TO BE THE STIMULUS FOR THE GRANULOMATOUS REACTION SINCE THE TWO REPEATED PAN TISSUE CULTURES HAVE BEEN NEGATIVE. ALSO, LICHEN SCIEROSUS ET ATROPHICUS HAS ECM1 AUTOANTIBODY (EXTRACELLULAR MATRIX 1 IS THE AUTOANTIGEN)." THE LSA IS BEING TREATED WITH TACOLIMUS .1% TOPICAL OINTMENT TWICE DAILY. THE GRANULOMATOUS DERMATITIS IS BEING TREATED WITH METHOTREXATE INTRALESIONAL INJECTION, AND DOXYCYCLINE. "TWO REPEATED PAN-TISSUE CULTURES STILL NO GROWTH TO DATE". "C

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 10524395 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT HAD BLISTER LIKE SORES FILLED WITH PUSS WITHIN A COUPLE DAYS/WEEK OF HER SURGERY. PATIENT INITIALLY THOUGHT IT WAS A BUG BIT BUT THEN SPREAD TO BOTH BREASTS. PATIENT WENT TO INFECTIOUS DISEASE AND WAS PUT ON ANTIBIOTICS BUT ISSUE DID NOT RESOLVE. HEALTHCARE PROFESSIONAL TOOK HER BACK TO THE OPERATING ROOM ON (B)(6) 2020 AND DID A POCKET EXAM. STRATTICE WAS WELL INCORPORATED AND NO SIGN OF FLUID AROUND THE IMPLANT. PATIENT SAW A DERMATOLOGIST TODAY AND THE DERMATOLOGIST FEELS IT MAY BE AN ¿ALLERGY TO ADM¿. A MEDICAL EXAM WAS PERFORMED BY PATIENT'S PRIMARY PROVIDER. CHIEF COMPLAINTS NOTED TO BE: "LICHEN SCLEROSUS ET ATROPHICUS" (LSA), AND "GRANULOMATOUS DERMATITIS". "STRATTICE MESH SUSPECTED TO BE THE STIMULUS FOR THE GRANULOMATOUS REACTION SINCE THE TWO REPEATED PAN TISSUE CULTURES HAVE BEEN NEGATIVE. ALSO, LICHEN SCIEROSUS ET ATROPHICUS HAS ECM1 AUTOANTIBODY (EXTRACELLULAR MATRIX 1 IS THE AUTOANTIGEN)." THE LSA IS BEING TREATED WITH TACOLIMUS .1% TOPICAL OINTMENT TWICE DAILY. THE GRANULOMATOUS DERMATITIS IS BEING TREATED WITH METHOTREXATE INTRALESIONAL INJECTION, AND DOXYCYCLINE. "TWO REPEATED PAN-TISSUE CULTURES STILL NO GROWTH TO DATE". "C

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 10524356 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SEEN ON JAN 28TH WITH MILD SWELLING OF LEFT BREAST THEN RETURNED TO THEIR OFFICE FEB 5 WITH AN ABSCESS VISIBLE THROUGH THE SKIN. THE IMPLANT AND STRATTICE WERE REMOVED THAT DAY IN THEIR OFFICE. WHEN WOUND WAS OPENED THERE WAS A LARGE AMOUNT OF PUS, NOT FOUL SMELLING, NO REDNESS IN SKIN OR FEVERS. THE STRATTICE WAS NOT ADHERED TO TISSUES AND SEEMED FLOPPY AND LOOSE. IT WAS REMOVED ALONG WITH THE PUS AND IMPLANT. 2 SETS OF CULTURES WERE OBTAINED, NO GROWTH IN EITHER. THE STRATTICE WAS LOOSE AND FLOPPY EVEN THOUGH IT HAD BEEN SUTURED WITH PDS. THE STRATTICE WAS REMOVED AND THE POCKET IRRIGATED AFTER CULTURES. THE PUS WAS SO ABUNDANT IT SURROUNDED IMPLANT AND STRATTICE. PATIENT IS FULLY HEALED BUT WITH SOME DEFORMITY DUE TO CONTRACTURE OF TISSUES (WOUND TREATED WITH WET TO DRY PACKINGS AND ALLOWED TO CLOSE BY SECONDARY INTENTION.

  Patient problems: Abscess

  MAUDE report 8495943 ↗