Macroplastique Implants MPQ-2.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717591240266), received between Feb 16, 2018 and Oct 24, 2022 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2022Material Erosion

  MACROPLASTIQUE BULKING AGENT INJECTION ERODED INTO URETHRA

  Patient problems: Failure of Implant

  MAUDE report 15663132 ↗
• MalfunctionJan 7, 2021Device Contamination with Chemical or Other Material

  THIS INCIDENT WAS PUBLISHED IN A JOURNAL ARTICLE. A PATIENT WITH A BACKGROUND OS STRESS URINARY INCONTINENCE UNDERWENT NUMEROUS PELVIC SURGERIES INCLUDING COLPOSUSPENSION, TENSION-FREE VAGINAL TAPE (TVT) AND MACROPLASTIQUE. SHE DEVELOPED BLEEDING FROM A 3CM URETHRAL CARUNCLE, WHICH DID NOT IMPROVE WITH VAGINAL OESTROGENS. SHE PROCEEDED TO HAVE A SURGICAL EXCISION OF THE CARUNCLE. HISTOLOGY REVEALED A FOREIGN MATERIAL WITH SURROUNDING FOREIGN-BODY-TYPE MULTINUCLEATE GIANT CELL REACTION. THE FOREIGN MATERIAL WAS COMPATIBLE WITH MACROPLASTIQUE MEANING THAT SOME MACROPLASTIQUE WAS REMOVED AS PART OF THE EXCISION OF THE CARUNCLE.

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11131046 ↗
• MalfunctionDec 7, 2018Migration or Expulsion of Device; Difficult to Remove

  THREE PATIENTS IN (B)(6) PRESENTED WITH POTENTIAL COMPLICATIONS POSSIBLY RELATED TO PRIOR IMPLANTATION OF MACROPLASTIQUE. ALL THREE PATIENTS HAD MACROPLASTIQUE IMPLANTED YEARS EARLIER; THE SUBJECT OF THIS REPORT HAD TWO INJECTIONS: ONE IN 1998 AND THE SECOND IN 2007. THE PATIENTS PRESENTED WITH RECURRENT INCONTINENCE AND URINARY TRACT INFECTIONS. THE REPORTER NOTED THAT THE BULKING MATERIAL WAS SAID TO HAVE BEEN EXPOSED/ERODED THROUGH THE EPITHELIUM OF THE BLADDER NECK AND/OR URETHRA. THE DOCTOR ATTEMPTED TO REMOVE THE MATERIAL, HOWEVER IF WAS SAID THE MACROPLASTIQUE WAS IMPOSSIBLE TO REMOVE.

  Patient problems: Incontinence; Urinary Tract Infection

  MAUDE report 8143732 ↗
• MalfunctionDec 7, 2018Migration or Expulsion of Device; Difficult to Remove

  THREE PATIENTS IN (B)(6) PRESENTED WITH POTENTIAL COMPLICATIONS POSSIBLY RELATED TO PRIOR IMPLANTATION OF MACROPLASTIQUE. EACH PATIENT HAD MACROPLASTIQUE IMPLANTED YEARS EARLIER AND PRESENTED WITH RECURRENT INCONTINENCE AND URINARY TRACT INFECTIONS. FOR EACH PATIENT, THE REPORTER NOTED THAT THE BULKING MATERIAL WAS SAID TO HAVE BEEN EXPOSED/ERODED THROUGH THE EPITHELIUM OF THE BLADDER NECK AND/OR URETHRA. THE DOCTOR TRIED TO EXPLANT THE MATERIAL, HOWEVER IF WAS SAID THE MACROPLASTIQUE WAS IMPOSSIBLE TO REMOVE.

  Patient problems: Incontinence; Urinary Tract Infection

  MAUDE report 8143406 ↗
• MalfunctionDec 7, 2018Material Erosion; Difficult to Remove

  THREE PATIENTS IN (B)(6) PRESENTED WITH POTENTIAL COMPLICATIONS POSSIBLY RELATED TO PRIOR IMPLANTATION OF MACROPLASTIQUE. EACH PATIENT HAD MACROPLASTIQUE IMPLANTED YEARS EARLIER AND PRESENTED WITH RECURRENT INCONTINENCE AND URINARY TRACT INFECTIONS. FOR EACH PATIENT THE REPORTER NOTED THAT THE BULKING MATERIAL WAS SAID TO HAVE BEEN EXPOSED/ERODED THROUGH THE EPITHELIUM OF THE BLADDER NECK AND/OR URETHRA. THE DOCTOR TRIED TO EXPLANT THE MATERIAL, HOWEVER IT WAS SAID THE MACROPLASTIQUE WAS IMPOSSIBLE TO REMOVE.

  Patient problems: Incontinence; Urinary Tract Infection

  MAUDE report 8143401 ↗
• MalfunctionSep 5, 2018Material Erosion

  A FEMALE PATIENT RECEIVED MACROPLASTIQUE INJECTIONS IN 2013, HAVING PREVIOUSLY UNDERGONE MIDURETERAL MESH SLING WITHOUT IMPROVEMENT IN HER URINARY INCONTINENCE. SHE PRESENTED RECENTLY WITH A 12 MONTH HISTORY OF PROGRESSIVE "VAGINAL" PAIN, ESPECIALLY FOLLOWING VOIDING. SHE WAS FOUND ON CYSTOSCOPY TO HAVE A BLADDER STONE ADHERENT TO ERODED MATERIAL (MACROPLASTIQUE) AT HER RIGHT BLADDER NECK. THE BLADDER STONE WAS TREATED ENDOSCOPICALLY WITH A HOLMIUM LASER, AND SOME OF THE MACROPLASTIQUE IMPLANT WAS PULLED OUT WITH THE USE OF ENDOSCOPIC GRASPING FORCEPS. MOST OF THE MACROPLASTIQUE WAS LEFT BEHIND.

  Patient problems: Foreign Body In Patient; Incontinence; No Code Available; Pain

  MAUDE report 7847007 ↗
• InjuryJun 29, 2018Device Operational Issue

  A (B)(6) YEAR OLD MALE WITH MILD PERSISTENT STRESS URINARY INCONTINENCE (SUI) AFTER A RADICAL PROSTATECTOMY UNDERWENT ELECTIVE INTRAURETERAL BULKING AGENT INJECTIONS. AFTER THE INITIAL MILD IMPROVEMENT, THE SUI PROGRESSED AND THE PATIENT REQUIRED 5 DIAPERS A DAY. THE PATIENT SUBSEQUENTLY HAD AN ARTIFICIAL URINARY SPHINCTER (AUS) PLACEMENT WITH IMPROVEMENT OF HIS LEAKAGE. TWO YEARS LATER, THE PATIENT REPRESENTED WITH WORSENING SUI DESPITE NORMAL AUS FUNCTION. UPON URETHROSCOPY, IT WAS DISCOVERED THAT THE PATIENT HAD URETHRAL EROSION WITH CRYSTALS THAT ENVELOPED HIS CUFF. THESE WERE FOUND TO BE MACROPLASTIQUE TYPE CRYSTALS DURING PATHOLOGIC EVALUATION. THREE ADDITIONAL PROCEDURES, INCLUDING AUS REMOVAL, OPEN AND ENDOSCOPIC PROCEDURES WERE REQUIRED TO REMOVE RESIDUAL MACROPLASTIQUE CRYSTALS.

  Patient problems: Erosion; Incontinence; No Code Available

  MAUDE report 7650146 ↗
• InjuryMar 13, 2018Insufficient Device Problem Information

  A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF STRESS INCONTINENCE, POST-MENOPAUSAL BLEEDING AND URGE INCONTINENCE WAS IMPLANTED WITH MACROPLASTIQUE (MPQ) IMPLANTS ON (B)(6) 2017. FORTY-EIGHT HOURS AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED AN ALLERGIC REACTION WHICH CAUSED STIFFNESS IN HER HANDS THAT PROGRESSED TO INCREASED PAIN IN THE JOINTS OF HER HANDS. THE PATIENT'S HANDS BECAME EXTREMELY RED AND WERE HOT TO THE TOUCH. A DOCTOR PRESCRIBED THE PATIENT WITH A 3 DAY COURSE OF 60 MG OF PREDNISONE. PATIENT STATED SHE FELT BETTER THE MORNING AFTER TAKING THE PREDNISONE. THE BULKING AGENT IS STILL IMPLANTED IN THE PATIENT.

  Patient problems: Erythema; Muscular Rigidity; Pain; Reaction

  MAUDE report 7333677 ↗
• MalfunctionMar 9, 2018Insufficient Device Problem Information

  A (B)(6) YEAR-OLD CAUCASIAN FEMALE FIRST PRESENTED 20 YEARS AGO WITH BLADDER PROLAPSE AND GENUINE STRESS URINARY INCONTINENCE (SUI). AFTER FAILING TO IMPROVE ON CONSERVATIVE MANAGEMENT AND COLPOSUSPENSION, SHE UNDERWENT A MACROPLASTIQUE (MPQ) INJECTION FOR PERSISTENT URODYNAMICALLY CONFIRMED SUI. SHE EXPERIENCED BRIEF SYMPTOMATIC IMPROVEMENT, BUT SYMPTOMS REOCCURRED WITHIN MONTHS, LEADING TO THREE SEPARATE INJECTIONS OF MPQ AT SIX MONTHLY INTERVALS. EACH OF THESE INJECTIONS HAD A SIMILAR OUTCOME AS PREVIOUSLY, BUT AFTER THE FINAL INJECTION, HER SYMPTOMS PARTIALLY SETTLED, BUT SHE EXPERIENCED STORAGE SYSTEMS. SEVEN YEARS AGO, THESE STORAGE SYSTEMS WORSENED. A CYSTOSCOPY PERFORMED SHOWED MUCOSAL SWELLINGS WITH CALCIFICATIONS CLOSE TO THE BLADDER NECK AND THE PROXIMAL URETHRA. THE CALCIFICATIONS WERE RESECTED, AND HISTOPATHOLOGY SHOWED FOREIGN MATERIAL WITHOUT MALIGNANCY. THE PATIENT'S SUI DID NOT DETERIORATE ANY FURTHER, HOWEVER SHE DEVELOPED URGENCY SYMPTOMS. TWO YEARS AGO, PATIENT WAS REFERRED FOR NON-VISIBLE HAEMATURIA WITH POST-MICTURITION PAIN. A CYSTOSCOPY REVEALED UNHEALTHY AREAS CLOSE TO THE BLADDER NECK THAT WERE RESECTED. HISTOPATHOLOGY SHOWED ONLY A FOREIGN BODY REACTION,

  Patient problems: No Code Available

  MAUDE report 7328022 ↗
• MalfunctionMar 2, 2018Migration or Expulsion of Device

  FEMALE PATIENT WHO PRESENTED WITH URINARY INCONTINENCE WAS INITIALLY TREATED VIA PUBOVAGINAL SLING IN 2005. IN (B)(6) 2013, PATIENT WAS GIVEN A SUBURETHRAL INJECTION OF MACROPLASTIQUE (MPQ) WITH GOOD RESULTS AND FOLLOW UP THROUGH 2014. IN (B)(6) 2017, THE PATIENT WAS REFERRED BACK TO HER DOCTOR FOR POSSIBLE BLADDER STONES - THE PATIENT REPORTED MILD BLADDER IRRITABILITY AND MINOR RECURRENT STRESS URINARY INCONTINENCE (SUI). THE PATIENT WAS FOUND TO HAVE MUCOSA WHICH HAD PERFORATED EXPOSING THE MPQ IMPLANT, AND ALSO HAD A BLADDER STONE WHICH DEVELOPED ON TOP OF THE EXPOSED MPQ IMPLANT. THE PATIENT UNDERWENT A CYSTOLITHOLAPAXY IN (B)(6) 2017 TO REMOVE THE BLADDER STONES. IT IS UNCLEAR IF THE MPQ IMPLANT WAS REMOVED, OR IF OTHER TREATMENT WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7310369 ↗
• MalfunctionFeb 16, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IN A RECENT PUBLICATION IN THE INTERNATIONAL UROGYNECOLOGY JOURNAL, IT WAS NOTED THAT A FEMALE PATIENT EXPERIENCED MIGRATION OF THE MPQ IMPLANT TO HER BLADDER. A POSTMENOPAUSAL WOMAN HAD AN MPQ INJECTION FOR INCONTINENCE IN 2011. IN 2014, SHE WAS DIAGNOSED WITH BLADDER CARCINOMA AND UNDERWENT TRANSURETHRAL RESECTION OF A BLADDER TUMOR. DURING A SURVEILLANCE CYSTOSCOPY, AN IRREGULAR AREA IN THE TRIGONE OF THE BLADDER WAS NOTED, AND RESECTED BY UROLOGY IN 2016. PATHOLOGY OF THE MASS RETURNED AS A FOREIGN BODY GIANT CELL REACTION WITH REFRACTILE GEL-LIKE MATERIAL CONSISTENT WITH MPQ.

  Patient problems: No Code Available

  MAUDE report 7278187 ↗
• MalfunctionFeb 16, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IN A RECENT PUBLICATION IN THE INTERNATIONAL UROGYNECOLOGY JOURNAL IT WAS NOTED THAT A PATIENT EXPERIENCED MIGRATION OF THE MPQ IMPLANT INTO HER VAGINA. A POSTMENOPOSAL WOMAN UNDERWNT PERIURETHRAL BULING WITH MPQ IN 2014 AND PRESENTED IN 2015 COMPLAINING OF A VAGINAL MASS. UPON EXAMINATION A FIRM 2-CM LATERAL PERIURETRAL MASS WAS OBSERVED. THE MASS WAS EXCISED AND THE PATIENT REPORTEDLY HEALED WELL. PATHOLOGY OF THE MASS RETURNED AS A FOREIGN BODY GIANT CELL REACTION WITH REFRACTILE GEL-LIKE MATERIAL CONSISTENT WITH MPQ.

  Patient problems: No Code Available

  MAUDE report 7277998 ↗