MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Hematoma (1884); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Discomfort (2330); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: international urogynecology journal (2021) 32:871¿877.Attempts are being made to obtain 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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (vicryl suture, ethibond suture, artisyn mesh, prolene mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? patient demographics? events related to patients with artisyn mesh reported via mw # 2210968-2021-08767.Events related to patients with vicryl suture reported via mw # 2210968-2021-08768.Events related to patients with ethibond suture reported via mw # 2210968-2021-08770.

Event Description

It was reported in a journal article with title: long-term safety and efficacy of laparoscopically placed mesh for apical prolapse.Since 2010, 93 female patients were underwent either a laparoscopic hysteropexy (lsh) for uterine prolapse or a sacrocolpopexy (lsc) for vaginal vault prolapse.Implant used for lsc was an artisyn (ethicon, somerville, nj, usa).The mesh was attached to the anterior longitudinal ligament over the vertebral body of l5 using helical metal tackers and to the vagina with 10-12 2-0 vicryl sutures (polyglactin, ethicon, somerville, nj, usa).Implants used for lsh was a prolene mesh (undyed polypropylene knitted non-absorbable mesh 15 cm×15 cm, ethicon, somerville, nj, usa).Ethibond (ethibond excel, polyethylene terephthalate, ethicon, somerville, nj, usa) was used to attach the mesh to the cervical body.Complications were categorized into intraoperative, immediate, short or long term.Intraoperative (n=1) started laparoscopically and converted to an open procedure because of adhesions (n=1) started laparoscopically and converted to an open procedure to complete the vmr because of scarred tissue planes in the rectovaginal space immediate (n=1) blood transfusion postoperatively for a conservatively managed abdominal hematoma.(n=1) re-suturing of a port site (under local anesthesia) for superficial bleeding requiring hemostasis.Short term (n=1) readmission for a bleeding port site which settled with a compression dressing.(n=8) wound problems (n=3) constipation (n=1) pain long term (n=1) bowel obstruction three years after a lsh.A segment of gangrenous small bowel (not perforated) was identified adherent to the mesh which required resection and primary anastomosis.The patient made a full recovery with no long-term sequalae.(n=2) vaginal mesh exposure were identified, five months and nine months post-laparoscopic sacrocolpopexy.Both cases had transvaginal excision of the exposed mesh performed as a day case with no further problems.(n=3) mild abdominal pain at follow-up but abdominal examination was unremarkable.(n=3) vaginal discomfort (n=4) superficial dyspareunia efficacy (n=4) early recurrence of apical prolapse following lsc.Repeat laparoscopy showed the mesh had stretched in two women and detached from the vaginal vault in the remaining two cases.In the cases where the mesh had stretched, the mesh was plicated via laparoscopy as a day case procedure with no longer term sequelae.In the two cases of detachment from the vault, one patient had a sacrospinous vault fixation (ssvf); the other had a ssvf with further recurrence and then a repeat lsc.Both patients had suffered severe constipation which caused extreme straining, leading to the recurrence (n=14) subsequent pelvic floor repairs.(n=11) stress urinary incontinence (sui) was reported by 31 patients although only 11 of these were de novo following surgery.(n=?) stage 1 or less prolapse.This study shows excellent long-term results from lsc and lsh with comprehensive follow-up, demonstrating a very low and acceptable level of intraoperative, short- and long-term complications.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 07/06/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: h6 clinical code: e2401 - constipation.H6 clinical code: e0505 - hematoma.H6 impact code: f0101 - therapeutic response decreased product complaint # (b)(4).Date sent to the fda: 07/06/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected information: removed h6 clinical code: e2101 - adhesions.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12516773
• MDR Text Key: 274290706
• Report Number: 2210968-2021-08769
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female