Strattice Reconstructive Tissue Matrix BPS CON3006Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M328CON30060), received between Mar 15, 2018 and Sep 11, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50743222 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50742850 ↗
• InjuryAug 31, 2026Lack of Effect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50522686 ↗
• InjuryAug 31, 2026Lack of Effect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521461 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT HAD RIGHT SIDE BREAST IMPLANT WITH STRATTICE IMPLANTED. THE PATIENT THEN SUFFERED "INFECTION AND EXTRUSION" OF THE IMPLANT. ON RE-OPERATION, THE TISSUE WAS NOTED TO BE "PARTIALLY DISSOLVED." THIS RECORD IS FOR THE STRATTICE TISSUE GRAFT. THE RELATED BREAST IMPLANT WAS PREVIOUSLY REPORTED UNDER MRN 9617229-2022-17949 (ABBVIE COMPLAINT NUMBER: (B)(4). PMQA RECEIVED A COMMUNICATION FROM FDA CBER REGARDING RELATED REPORT MRN: 1000306051-2025-00032 (ABBVIE COMPLAINT NUMBER: (B)(4) REPORTING ADDITIONAL INFORMATION PROVIDED BY THE SURGEON ON (B)(6) 2025. THE SURGEON REPORTED PATIENT "HAD REPLACEMENT OF BILATERAL IMPLANTS WITH CAPSULECTOMIES AND STRATTICE SLINGS ON (B)(6) 2025." THE SURGEON PROVIDED LOT NUMBERS WHICH WERE FOR STRATTICE TISSUE. THEREFORE, IT IS ASSUMED THAT THE PATIENT HAD STRATTICE TISSUE IMPLANTED AND NOT ALLODERM.

  Patient problems: Bacterial Infection

  MAUDE report 22012994 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE HCP THAT A PATIENT HAD STRATTICE LOT, SP200412-125, TO THE PERI PROSTHETIC CAPSULE FOR TREATMENT OF CONTRACTURE AND FOR LOWER POLE SUPPORT ON THE RIGHT SIDE. SHE DID NOT WEAR HER BRA AND BOUNCED HER BREASTS AROUND QUITE A BIT (EXTREMELY LARGE AND FLAT AND LONG) AND HER RIGHT BREAST STRATTICE BECAME DISPLACED UNBEKNOWNST TO THE HCP. SHE DEVELOPED A CONTRACTURE ON THAT SIDE AND WAS NOT RESPONSIVE TO MASSAGE OR ULTRASOUND TREATMENTS. RE-OPERATION WAS UNDERTAKEN AND SHE HAD RED DOTS OF INFLAMMATORY CELLS ALL OVER HER NATIVE CAPSULE (BIOPSY SHOWED GIANT CELL REACTION WITH EOSINOPHILS) AND A SMALL AMOUNT OF CLEAR FLUID AND A POCKET OF STERILE PURULENT MATERIAL IN THE AREA OF THE DISPLACED AND CRUMPLED STRATTICE. THE HCP DEBRIDED THE UNINCORPORATED STRATTICE, CLEANED OUT ALL DEBRIS AND INJECTED THE CAPSULE WITH KENALOG WHERE THEY WOULD NOT INTERFERE WITH THE PATIENT'S EXTREMELY THIN SOFT TISSUE IMPLANT COVERAGE (ESSENTIALLY SKIN ON IMPLANT) AND PUT THE IMPLANT BACK IN. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 AND DID FINE FOR SEVERAL WEEKS AND AS AN AFTER THOUGHT, WAS PUT ON STEROIDS POST OPERATIVELY. THE PATIENT WAS SEEN (B)(6) AND

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17454656 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE CUSTOMER THAT A PATIENT PREVIOUSLY IMPLANTED WITH STRATTICE WHO HAD A COMPLAINT OF CAPSULAR CONTRACTURE ON THE RIGHT BREAST, NOW DEVELOPED GRADE 4 CAPSULAR CONTRACTURE ON THE LEFT BREAST. THE HCP IS PLANNING TO REMOVE AND IMPLANT 2 NEW PIECES ON HER LEFT SIDE IN JULY. THE PATIENT ALSO HAS MENTOR SILICONE GEL IMPLANTS. THE PREVIOUS COMPLAINT FOR THE RIGHT BREAST IS DOCUMENTED UNDER (B)(4) MDR# 1000306051-2023-00020. THIS RECORD IS ASSOCIATED WITH HER LEFT BREAST, LOT SP200344-150.

  Patient problems: Capsular Contracture

  MAUDE report 17201163 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE HCP THAT THEY HAVE A PATIENT WHO DEVELOPED CAPSULAR CONTRACTURE WITH STRATTICE LOT: SP200354-085 IMPLANTED ON (B)(6) 2022. THEY ARE REMOVING AND IMPLANTING A NEW PIECE. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 18/JAN/2023 THAT THE PATIENT UNDERWENT BREAST AUGMENTATION WITH PLACEMENT OF SILICONE GEL IMPLANTS. THERE WAS FIRMNESS ON RIGHT BREAST NOTED ON 5 MONTHS LATER, 7 MONTHS GRADE 4 CAPSULAR CONTRACTURE NOTED. TREATMENT INCLUDED RIGHT BREAST REMOVAL AND REPLACEMENT OF SILICONE GEL IMPLANT, 2 PIECES OF ADM. IT WAS NOTED THE PATIENT HAS A PREVIOUS HISTORY OF CAPSULAR CONTRACTURE.

  Patient problems: Capsular Contracture

  MAUDE report 16268910 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON OPERATED ON A FEMALE PATIENT AND USED TWO PIECES OF STRATTICE CON3006, ONE ON THE RIGHT SIDE AND ONE ON THE LEFT SIDE. APPROXIMATELY 3 WEEKS POST-OP, SHE PRESENTED IN THE OFFICE WITH REDNESS AND SWELLING OF THE RIGHT BREAST. THE SURGEON ENDED UP TAKING THE PATIENT TO THE OPERATING ROOM AND FOUND A LARGE SEROMA IN WHICH HE DRAINED ROUGHLY 150-200CC¿S OF FLUID. THAT FLUID WAS SENT TO PATHOLOGY AND CULTURED. THE CULTURE CAME BACK POSITIVE FOR GRAM NEGATIVE BACTERIA COCCOBACILLI. STRATTICE WAS REMOVED AT THAT TIME DUE TO THE POSITIVE CULTURE AND ANTIBIOTICS WERE GIVEN POST OP. THE SURGEON SAW THE PATIENT BACK IN THE OFFICE ON 7/19 AND SHE IS UNFORTUNATELY TIGHTENING UP AGAIN ON HER RIGHT BREAST. THE SURGEON WILL NEED TO TAKE HER BACK TO SURGERY AGAIN AND IS BOOKED FOR (B)(6) 2021. THE SURGEON WILL DO A RIGHT CAPSULECTOMY AT THAT TIME, PUT IN A NEW IMPLANT AND A NEW PIECE OF STRATTICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS WAS A HEALTHY COSMETIC PATIENT WITH NO REPORTED COMORBIDITIES. THE SYMPTOMS ARE ONLY PERTAINING TO THE PATIENT'S RIGHT BREAST, BUT THE DOCTOR DOES NOT INDICATE A RELATIONSHIP BETWEEN THE STRATTICE AND THE INFECT

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 12342722 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DID WELL AFTER THE FIRST PROCEDURE (B)(6) 2017. THEY HAD MILD INFERIOR DESCENT OF THE IMPLANTS AND WAS GOING TO THE OR FOR FACIAL SURGERY UNDER THE CARE OF DOCTOR'S PARTNER. DOCTOR OPENED THE VERTICAL INCISION AND PERFORMED B INFERIOR CAPSULORRHAPHY WITH A GOOD AESTHETIC ON TABLE RESULT. THE STRATTICE APPEARED TO BE WILL INCORPORATED AT THAT TIME. NON-INCORPORATED STRATTICE WAS REMOVED WITH BREAST IMPLANT ON (B)(6) 2018. PATIENT RETURNED TO OR ON (B)(6) 2019 FOR FURTHER DEBRIDEMENT OF INCORPORATED STRATTICE AND PRODUCTS OF DEGRADATION OF STRATTICE DUE TO U/S EVIDENCE OF FLUID COLLECTION WHICH WAS THE STERILE, MURKY APPEARING BREAKDOWN OF THE RESIDUAL STRATTICE. DOCTOR INDICATED THAT AROUND THIS TIME THE PATIENT DEVELOPED JOIN SWELLING IN THEIR HAND, AND IT LOOKED LIKE RAYNAUD'S SYNDROME. DOCTOR STATED IT SEEMS TO BE THAT THE STRATTICE ¿MELTED¿ AND CAUSED AN INFLAMMATORY RESPONSE LEADING TO THE LOSS OF BREAST IMPLANT. AFFECTED BREAST IS LEFT. AFFECTED LOT IS SP100528.

  Patient problems: Inflammation; Irritation

  MAUDE report 10025081 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2020, PATIENT'S RIGHT BREAST BECAME FIRM. DOCTOR SAW THE PATIENT AND DETERMINED THAT THEY HAD AN IMPENDING EXTRUSION. DOCTOR REPORTED THAT THE PATIENT HAD SWELLING AND ERYTHEMA OF BOTH HANDS WHICH APPEARED TO RESEMBLE RAYNAUD¿S WITH SWELLING OF THE JOINTS OF THE HAND. RHEUMATOLOGY WORK UP WAS NEGATIVE. WITH THIS MOST RECENT RIGHT SIDE EXPLANT THE PATIENT NOTED A RECURRENCE OF HAND SWELLING WITHIN TWO WEEKS OF THE DEVELOPMENT OF THE IMPENDING EXTRUSION. WHEN THE DOCTOR OPENED THE INCISION THERE WAS A NON-ODOROUS CREAMY FLUID, NO DOUBT, BROKEN DOWN STRATTICE. THEY REMOVED THE IMPLANT AND REMOVED AS MUCH OF THE RESIDUAL INTACT STRATTICE ALONG THE FOLD. STRATTICE DID NOT INTEGRATE WITH THE PATIENT WAS NOTED TO BE INTEGRATED AT CAPSULORRHAPHY PROCEDURE ON (B)(6) 2018. DOCTOR REPORTED THAT IT SEEMS TO BE THAT THE STRATTICE "MELTED" AND CAUSED AN INFLAMMATORY RESPONSE LEADING TO THE LOSS OF BREAST IMPLANT. AFFECTED SIDE IS RIGHT BREAST. AFFECTED LOT IS SP100528.

  Patient problems: Foreign Body Reaction

  MAUDE report 10025066 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RECURRENCE OF CAPSULAR CONTRACTURE WITH BAKER GRADE III. THE STRATTICE WAS PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020. LOT SP200083 WAS AFFECTED AND DISCARDED AFTER SURGERY.

  Patient problems: Capsular Contracture

  MAUDE report 9781396 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH STRATTICE BPS ON (B)(6) 2019. IN THE MONTHS FOLLOWING SURGERY, THE PATIENT EXPERIENCED RECURRENT CAPSULAR CONTRACTURE ON THE RIGHT BREAST. EXPLANT OF THE DEVICE OCCURRED ON (B)(6) 2019. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 8612667 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE "III-IV". DEVICE STATUS IS UNKNOWN.

  Patient problems: Capsular Contracture

  MAUDE report 8210114 ↗
• InjuryMar 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2016, A FEMALE PATIENT UNDERWENT BILATERAL CAPSULAR CONTRACTURE REPAIR WITH BREAST IMPLANTS AND STATICE. DRAINS HAD BEEN PLACED AND MAINTAINED UNTIL THE 24-HOUR OUTPUT WAS 20CC OR LESS. THE PATIENT NOTED A PALPABLE NODULE IN HER LEFT LATERAL BREAST WITHIN SIX MONTHS AFTER THIS SURGERY, BUT WAS OTHERWISE PLEASED WITH HER RESULTS. THERE IS NO HISTORY OF CHEMOTHERAPY OR RADIATION TREATMENT. THE PATIENT, NOW (B)(6), COMPLAINED OF "PUCKERING, " WOULD LIKE TO BE SOFTER, MORE SYMMETRIC AND IMPROVE THE AREOLAR PUCKERING. THE SURGEON SUSPECTED THAT THE MESH HAD FOLDED NEAR THE SUTURE LINE. ON (B)(6) 2018, THE DEVICE WAS FOUND TO BE UNINCORPORATED AND WAS SURGICALLY REMOVED. THE PATIENT DID NOT HAVE GOOD VASCULARIZATION AT THE TIME OF IMPLANT. THE ONLY AREAS OF ATTACHMENT WERE WHERE THE MESH WAS SUTURED IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342849 ↗