MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Citation: hernia (2009) 13:121¿129; doi 10. 1007/s10029-008-0443-4; published online: 13 november 2008 (b)(4).

Event Description

It was reported via journal article: "title: prolene hernia system, lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial" authors: j. Dalenbäck ¿ c. Andersson ¿ b. Anesten ¿ s. Björck ¿ s. Eklund ¿ o. Magnusson ¿ g. Rimbäck ¿ b. Stenquist ¿ n. Wedel citation: hernia (2009) 13:121¿129; doi 10. 1007/s10029-008-0443-4; published online: 13 november 2008 the aim of this prospective, controlled and randomized study is to to establish if any diverences concerning these aspects could be detected following three principally diverent techniques for primary inguinal hernia repair. The meshes that were used for the respective hernioplasties were for lichtenstein, prolene® mesh 10x15 cm (ethicon inc. , (b)(4)), for p bard perfix® plug size large (davol inc. , (b)(4)) and for phs prolene® hernia system extended (phs, ethicon inc. , (b)(4)). A total of 472 men between 30 and 75 years of age with primary inguinal hernias were included in the study. There were 158 patients in the lichtenstein group, 159 patients in the perfix grou and 155 patients in the phs group respectively. In the lichtenstein group, medial defect inverted by a running absorbable suture (vicryl® 3/0, ethicon inc. , (b)(4)). Mesh and slit part secured and sutured to the shelving margin of poupart¿s ligament just lateral to the completion knot of the running suture, ¿sling¿ mechanism, with a non-absorbable suture (prolene® 2/0). In the p bard perfix group, the plug (bard® perfix® plug, bard/davol inc. , (b)(4)) sutured to the margins of the defect with absorbable sutures (vicryl® 3/0). Direct hernias repaired with xl plug or two l plugs and sutured with 8¿10 interrupted sutures (vicryl® 3/0). Indirect plugs secured with 4¿8 sutures (vicryl® 3/0). If sutures were deemed appropriate, absorbable sutures were used (vicryl® 3/0). Mesh tails brought together with absorbable sutures (vicryl® 3/0). In the phs group, the on-lay graft is sutured with non-absorbable sutures (2/0 prolene) over the pubic tubercle, at the middle of the transversus arch and at the middle of the inguinal ligament. Immediate postoperative complications in the lichtenstein group included minor haematoma (n
=
1) and severe pain (n
=
2) were reported. Late complications, 30 days postoperative days included haematoma (n
=
7), infection (n
=
2) were reported. Immediate postoperative complications in the perfix group included minor haematoma (n
=
2) and severe pain (n
=
1) were reported. Late complications, 30 days postoperative days included haematoma (n
=
17), infection (n
=
1), transient neuralgia (n
=
2) were reported. Immediate postoperative complications in the phs group included minor haematoma (n
=
1) and severe pain (n
=
2) were reported. Late complications, 30 days postoperative days included haematoma (n
=
14), infection (n
=
6), transient neuralgia (n
=
3) were reported. There is no need for any early surgical re-intervention and only one serious event with a deep infection of an l mesh that was removed with subsequent uneventful recovery and no inguinal hernia recurrence during the study period. There are 3 recurrences occurred in the phs group during the 3 years follow-up. In conclusion, all the evaluated mesh techniques are suitable for execution under local anaesthesia. In conclusion, the prolene hernia system and plug-and-patch techniques can be performed with shorter operation times than the lichtenstein method. Early and late outcomes are, however, comparable, with few and insignificant differences concerning complication rates, return to full functional ability and/or pain response.

• Brand Name: PROLENE HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JPAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7651455
• MDR Text Key: 112843535
• Report Number: 2210968-2018-73941
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/29/2018 Patient Sequence Number: 1