MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Blood Loss (2597); Not Applicable (3189)

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 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 (tension-free vaginal tape- secur and obturator) 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 product involved? citation: int urogynecol j.2013; 24: 1459¿1465.Doi: 10.1007/s00192-012-1998-2.(b)(4).

Event Description

It was reported via journal article: "title: single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial".Authors: ana maria h.M.Bianchi-ferraro, zsuzsanna i.K.Jarmy-di bella, rodrigo de a.Castro, maria augusta t.Bortolini, marair g.F.Sartori, manoel j.B.C.Girão.Citation: int urogynecol j.2013; 24: 1459¿1465.Doi: 10.1007/s00192-012-1998-2.The authors tested the hypothesis that the single-incision sling, tvt-secur, placed in u position is not inferior to tvt-o for treating stress urinary incontinence (sui).This was a non-inferiority, prospective, randomized controlled trial in which women with sui, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either gynecare tvt-o (ethicon) in 56 patients (age: 52.13 years; bmi: 30.02) or gynecare tvt-secur (ethicon) in 66 patients (age: 54.05 years; bmi: 29.84).Perineorrhaphy was performed as an associated procedure to tvt-o in 25 % of cases.Tvt-s insertion technique used was the u approach, as previously described, in order to make sure that tape extremities were in close contact with the posterior surface of the pubic bone and were inserted at a 45° angle in relation to the saggital plane.The tape was adjusted by cough stress test, with 300 ml of intravesical volume.In the tvt-o group, reported complications included vaginal mucosa perforation (n-4) which required vaginal mucosa transfixation, urinary retention (n-2) which were treated with indwelling foley catheterization, urinary infection (n-4), thigh pain (n-15), tape exposure (n-1) which was successfully treated with conservative local estrogen therapy, de novo urgency (n-2) which required physiotherapy with satisfactory responses, and failed objective and subjective cure (n-5) which required surgical re-intervention in 1 patient, physiotherapy in 2 patients, and others did not desire additional treatment due to referred leakage improvement.In the tvt-s group, reported complications included vaginal mucosa perforation (n-4) which required vaginal mucosa transfixation, bleeding (n-1) which was managed conservatively with local compression, urinary retention (n-2) which were treated with indwelling foley catheterization, urinary infection (n-3), thigh pain (n-1), tape exposure (n-2) which was repaired by vaginal mucosa closure in 1 patient and by exposed-fragment resection in 1 patient, de novo urgency (n-1) which required physiotherapy with satisfactory responses, and failed objective and subjective cure (n-5) which required surgical re-intervention in 1 patient and the others referred improvement and did not want complementary treatment.The authors concluded that tvt-s efficacy was not inferior to tvt-o and has the advantage of being associated with lower postoperative pain.Tvt-s may be considered as an alternative treatment for sui.However, as it is a novel procedure, this sis must pass the evaluation of time, which requires more long-term studies.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018 additional information was requested, and the following was obtained: 1.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.- the cases reported in the article were not previous discussed with the company 2.Does the surgeon believe that ethicon products (tension-free vaginal tape- secur and obturator) involved caused and/or contributed to the post-operative complications described in the article? -the authors are all urogynecologists and believe that the complications described in the article were considered minor complications and, expected, in frequency and in types, according to the approach used to perform the sling.3.Does the surgeon believe there was any deficiency with the ethicon products involved?" -all patients, previous to participate in this study were aware that those complications could occur and their frequency, and without exception all of them have signed up the informed consent form.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8043671
• MDR Text Key: 126306923
• Report Number: 2210968-2018-76987
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 11/24/2018
• 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