MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon (polydioxanone suture) products involved caused and/or contributed to the post-operative complications and patient deaths described in the article? does the surgeon believe there was any deficiency with the ethicon (polydioxanone suture) products used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: obstet gynecol 2019;134:323¿32; doi: 10.1097/aog.0000000000003380.Adverse event regarding (b)(6) years old female underwent a prolift transvaginal mesh repair due to vault prolapse was submitted via 2210968-2020-03597.Adverse event regarding (b)(6) years old female ¿had another recurrence for which she does not want to undergo reoperation¿ was submitted.Adverse events occurred in the patients which were not identified in the journal article were submitted via 2210968-2020-03559, 2210968-2020-03598 and 2210968-2020-03599.

Event Description

Title: long-term assessment of a prospective cohort of patients undergoing laparoscopic sacrocolpopexy: the aim of this prospective cohort study was to report the long-term outcomes of laparoscopic sacrocolpopexy using a patient-centered approach by reporting the patient global impression of change score as a primary outcome measure.This cohort was initiated in 1996 and includes all consecutive patients who presented with symptomatic and anatomical prolapse (pelvic organ prolapse quantification [pop-q] stage 2 or greater) with involvement of the apical compartment.Starting with patient 214 out of the 331 included patients, the suture material changed from polyester 0 multifilament sutures (ethibond) (ethicon) to 0 polydioxanone monofilament (pds) to reduce the number of suture exposures.An additional change in surgical technique was to move to a lighter polypropylene implant to reduce graft-related complications.They initially used heavy-weight marlex mesh, changing in august 1999 to gynemesh (ethicon), and in november 2004 to pelvitex; from january 2007, ultrapro (ethicon) was used after resorption of poliglecaprone.A total of 270 women (mean age at study closure: 72 years, mean bm: 25 kg/m2) were included in the analysis; 185 patients were both physically examined and interviewed, and 95 were interviewed only.Complaints included persisting and new symptoms of: prolapse (n=? persisting, n=? new), sui (n=? persisting, n=? new), uui (n=? persisting, n=? new), urinary urgency (n=? persisting, n=? new), urinary frequency (n=? persisting, n=? new), obstructive voiding (n=? persisting, n=? new), constipation (n=? persisting, n=? new), fecal incontinence (n=? persisting, n=? new), sexual dysfunction (n=? persisting, n=? new), dyspareunia (n=? persisting, n=? new), and interference by bulge (n=? persisting, n=? new).One of the patients who had vault prolapse reoperation (n=(b)(6) year old woman) was referred to a center where she underwent an uneventful prolift transvaginal mesh repair (ethicon) but had another recurrence for which she does not want to undergo reoperation.Other reported complication are graft-related complication (n=?), mesh exposure (n=?), small bowel obstruction due to periumbilical adhesions (n=?), pain (n=?), sinus tract draining purulent discharge (n=?), rectovaginal fistula (n=?).Also, there were reported of suture exposures (n=9) occurred in patients who used ethibond.In conclusion, more than four out of five patients (82.5%) felt improved 86 months after laparoscopic sacrocolpopexy.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10007449
• MDR Text Key: 190526825
• Report Number: 2210968-2020-03566
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1