Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia Repair

Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia Repair
MedSun: Newsletter #36, May 2009

Surgical mesh is a polymeric, biologic or metallic screen intended for implant to reinforce soft tissue or bone where weakness exists. It is typically used in surgery for the repair, reconstruction, or substitution of tissue, commonly in hernia repair surgical procedures.

Over the past 2 years, MedSun has received 29 adverse event reports associated with 30 hernia mesh products in 30 patients. The reports were submitted by 20 hospitals between February 2007 and April 2009. The most frequently reported device problems were:

• Mesh explanted due to recall (6 reports)
• Ring breakage (4 reports)
• Mesh tear (4 reports)
• Defective mesh (3 reports)
• Mesh perforation (3 reports)
• Adhesion issue (2 reports)
• Mesh erosion (2 reports)

None of the reports involved a patient death. Common patient injuries listed below were reported in 15 of these 30 patients. Note: more than one patient injury can be assigned to each report.

• Additional surgical procedure required (18 reports)
• Infection (5 reports)
• Abscess (4 reports)
• Pain/soreness (3 reports)
• Inflammation/swelling (3 reports)

All reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 20 reports involved female patients and a total of 10 reports involved male patients.

MedSun reports contributed to FDA awareness of these device problems. Complications have been reported with a range of hernia mesh manufacturers, a majority of which are associated with the use of Composix Kugel Hernia Patches manufactured by Davol Incorporated, a subsidiary of C.R. Bard. The Bard Composix Kugel Extra Large Oval Patches were first recalled in December 2005. This Class I recall was expanded two times after the original recall notice, first in March 2006 and again on January 24, 2007, which ultimately recalled all product codes and lot numbers belonging to the Bard Composix Kugel Mesh Patches.

In October 2008, the FDA updated its safety information on hernia mesh repair.

Although the vast majority of reports were related to the recalled meshes, MedSun continues to see reports discussing adverse reactions with the recalled mesh, as well as with other mesh products. FDA continues to analyze and evaluate incoming reports about issues with all hernia mesh products.

[Note: The reports have been edited for clarity]

MedSun Surgical Hernia Mesh Adverse Event Reports Received Between February 2007 and April 2009 Device Manufacturer
Device Identifiers
Event Description

Covidien United States Surgical Corporation Parietex Composite (PCO) Model: PCO15 Lot: P1F00935 The patient had a ventral hernia repair. 21 days later, the patient returned for recurrent ventral hernia repair to replace the mesh. The surgeon stated that the mesh was "destructed from suture” and the mesh was stuck to the bowel.
Davol Inc. A subdivision of C.R. Bard, Inc.
Kugel Bard composite mesh
Hernia mesh failed and resulted in infection. Patient has a history of a ventral hernia for which she has suffered chronic infected mesh. She has undergone multiple abdominal wall surgeries since that time.
Davol Inc. A subdivision of C.R. Bard, Inc.
Kugel Composix 10.7x13.7cm
Large piece of Bard Kugel Composix mesh was explanted from the patient. The explanted mesh was part of the recall. Patient experienced chronic hernial infection, located inferior to mesh.
Davol Inc. A subdivision of C.R. Bard, Inc.
Bard Composix mesh
Bard Kugel Composix mesh was explanted from the patient per nationwide recall.
Davol Inc. A subdivision of C.R. Bard, Inc. Bard Composix Kugel Hernia Patch Small Oval
Lot: 43LQD184
Mesh implanted to repair ventral hernia. Patient experienced continued tenderness and bulging to the Right Lower Quadrant (RLQ). Mesh was removed after a few months, with re-repair of ventral hernia and insertion of new mesh.
Unknown Composix Mesh
Patient had mesh implanted many years ago at a different facility to repair ventral hernia. Patient has had hernia reoccurrence despite having mesh implanted. Patient has also experienced a chronic abdominal wound, which was packed.

This patient was seen at our facility with purulent drainage from wound, despite packing. Patient was found to have an exposed and infected mesh. Patient went to the Operating Room for an exploratory laporoscopy where we performed the following: removal of infected mesh, removal of old packing, drainage of marsupialized cavity, and closure with Permacol mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Bard Composix Kugel Mesh Patch
Lot: 43APD292
Cat: 10207
Patient had partial small-bowel obstruction secondary to adhesions that resulted in multiple hospitalizations and required surgery. At the time of surgery, during the dissection of the adhesions to the anterior abdominal wall, the left lateral inferior portion of the prosthesis was found with a fracture to the periphery of the supporting ring. The prosthesis was adherent to loops of small bowel.
Davol Inc. A subdivision of C.R. Bard, Inc. Kugel Hernia Patch
Lot: 43KMD157
Cat: 10105
The patient was brought to the OR for explantation of a MRSA-infected Kugel hernia patch, which had been implanted a few years ago. We excised the abdominal wall mesh and repaired the resultant epigastric defect with a 20 x 10 cm Permacol mesh.
Bard Access Systems Composix Kugel
Lot: 43CND224
Cat: 10202
Recoil ring breakage of Kugel Mesh (used for hernia repair) caused abscess to patient's abdominal wall.
Lifecell Corp Alloderm 6x16cm
Lot: NR: B20904-047
The alloderm product used for hernia repair had ruptured.
Ethicon, Inc. Proceed
Lot: ZLG767
Other: PCDG1
This patient had a hernia repair for three ventral and one umbilical hernia (all three ventral hernias and the umbilical hernia were connected into one large hernia). An approximate 5 X 7 piece of PROCEED mesh was used for this repair. The mesh was placed as an underlay and secured circumferentially with transfascial 0 Prolene sutures. A total of eight sutures were used to secure the PROCEED Mesh. Care was taken to identify the bowel throughout the entire procedure. The physician noted that the patient tolerated the procedure well without complication and was taken to the recovery room in satisfactory condition.

The procedure was done as a same-day-surgery procedure. When at home later that day, the patient developed nausea and vomiting. On the third post-op day, the patient was seen in the Emergency Department with a chief complaint of abdominal pain, nausea/vomiting, and abdominal distention. The patient had not passed any gas or had any bowel movement after the surgery. A CT scan demonstrated that a loop of small bowel incarcerated in the incisional ventral hernia repair. The patient was brought back in for surgery. The physician noted that the etiology of the incarceration was due to the fact that three of the eight transfascial sutures had pulled through the mesh. To remedy the situation, the entire mesh was removed and replaced with a new piece of mesh. The patient tolerated the procedure without complication and was discharged to home five days post-operation.
LifeCell Corporation AlloDerm Regenerative Tissue Matrix
Other: 402025
Patient underwent resection of pilocytic astrocytoma in the posterior fossa. The hospital course was uneventful and the patient was discharged a few days later. The patient returned the next day with fever and pain. The patient was admitted and treated with antibiotics. Cerebrospinal fluid culture revealed an enterobacter aerogenes infection. Nine days later, the patient returned to surgery. There was minimal collection of purulent material in the epidural space; however there was significant collection in the subdural space. The graft to the dura was removed and a new graft from the periosteum was sewn into place.
Tissue Science Laboratories Permacol 15 x 20cm x 1.0mm
Model: REF 101520
Lot: 07B01-9
Patient returned to the Operating Room (OR) for bowel perforation and adhesions. The surgeon dictated in his surgical report that the mesh that had been implanted the previous week had, under pressure, split in the mid-portion. The mesh was removed and none was replaced.
Davol Inc. A subdivision of C.R. Bard, Inc. Kugel Composix
Model:10208
Lot:73COD293
Cat:10208
The patient complained of periumbilical pain and requested that the recalled mesh be removed.
Bard Urological Division Avaulta Solo Synthetic Support System
Lot: CVRK0018
Cat: 486200
Bard Avaulta Solo Posterior Synthetic Support System Mesh tore when being applied. Surgeon was able to complete the procedure with the remainder of the mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel Mesh
Lot: HURB3676
Other:10206
Patient had dehiscence of ventral herniography with surgical mesh. Patient returned to surgery for repair. Operative Note: Patient noted in Recovery Room (RR) to have disruption to the lower part of ventral abdominal hernia repair. Bard composite graft was attached three fourths of the way around his ventral abdominal wall defect. However, distally in the lower part of the incision, the 1-0 Prolene horizontal mattress sutures were disrupted, as were the staples. The Bard composite graft and the staples achieved very poor mesh adherence to the abdominal wall. Surgeon increased the length of the Bard composite graft by sewing another piece of Bard composite graft to the ventral aspect to the largest of the Bard composite graft that was previously implanted.
Davol Inc. A subdivision of C.R. Bard, Inc. None
Mesh removed.
Composix Abdominal mesh
Defective Gortex mesh. Patient had undergone 3 or more incisional hernia repairs with a low transverse abdominal incision, initially made for acute diverticulitis. The patient had a painful bulge in the lower left abdomen and a recurrent hernia on the right lower abdomen, due to failure of the Gortex mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel
Lots: 43GPD434 & 43KOD267
Cat: 10202 Two events involving the same brand (two different lots) of the Kugel hernia mesh. Both lots of the mesh were recalled via a Class I recall in January of this year (2007). The first patient was initially treated for a gunshot wound to the abdomen and developed an incisional hernia, which were repaired with a Kugel patch prior to release of the recall. He recently presented with a recurrent incisional hernia at the 9 and 10 o'clock position. The doctor removed the patch and replaced it with another brand of mesh.

The second patient had a laparoscopic nephrectomy done by a hand-port incisional hernia. The defect was initially repaired with a Kugel mesh device. Approximately a year post-operation, the patient gained 30 pounds and had a reoccurrence of the previous hernia.
Bard Urological Division Pelvicol Acellular Collagen Matrix
Lot: 06B15-1
Other: Reorder No: 482812
Patient with complication (abscess and inflammation) at site of previous surgery where mesh was implanted. Per surgeon, the term "erosion" is what is used in ICD9CM, but is not very accurate. The abscess was cultured, no growth. The mesh was surgically removed 2 months later.
Bard Urological Division Pelvisoft Acelluar Collagen BioMesh
Lot: 06B15-9
Patient with complication (abscess and inflammation) at site of previous surgery where mesh was implanted. The abscess was cultured, no growth. The mesh was surgically removed 5 months later.
Bard Access Systems Bard Composix Kugel Hernia Patch
Lot: 43E0D214
Other: Ref 0010202
Incisional ventral hernia repaired with Bard Mesh, which eventually had to be removed due to defect.
Bard Access Systems Ventralex Hernia Patch
Lot: 43DQD395
Cat: 10302 Patient had a laparoscopic ventral hernia repair. According to the physician, the patient progressed postoperatively as expected, without complication. However, four days later, the patient's condition worsened and the patient had to undergo open surgery where two perforations were noted in the small bowel.
Bard Access Systems Composix Kugel Hernia Patch
Lot: 43EQD414
Cat: 10205 Patient had a laparoscopic ventral hernia repair last year. The patient progressed postoperatively as expected, without complication. However, four days postoperative, the patient's condition worsened and the patient had to undergo open surgery where two perforations were noted in the small bowel.

According to the physician, the Composix Mesh was removed and it was noted that the patch had not retained its oval shape. The patch appeared crumpled on both sides and had creases running along the center of the mesh, indicating that the ring had broken.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel
Model: 10206
Lot: 43APD431 The mesh was placed prior to the manufacturing recall. The patient was brought in for a bowel stricture procedure and, during this surgery, the mesh was identified. Because we were aware that this may have been a recalled mesh product, we called Davol, Inc./C.R. Bard and they confirmed that this was, in fact, a piece of mesh that had been recalled. It was decided that we would remove the mesh, just to be safe.
Bard Access Systems Composix Kugel
Lot: 41ELDP27
Other: REF 0010204 Patient had a bowel obstruction from an incarcerated hernia placed late last year. During that repair the midline incision divided the mesh, which was repaired with nylon. Patient developed a draining wound since that repair.
Ethicon, Inc. Proceed A six month extension was given by the company on outdated mesh. As surgeon was sewing the mesh to the abdomen, the mesh separated. This is not what the mesh is designed to do. The sales representative was notified. The mesh was removed from the patient's abdomen and a different type of (current) mesh was used. All other meshes were pulled from our shelves.

Excerpt from September 2006 Customer Letter:
“Dear Customer,
We are pleased to announce that we have successfully completed stability studies designed to extend the shelf life of PROCEED Surgical Mesh. The results of these studies allow us to expand current expiry dating for an additional six (6) months. This additional data allows for a 12-month shelf-life. An additional 6 months should be added to the date printed on the PROCEED Mesh package for any product currently on the market with an expiration date prior to and including March 2007 (2007 - 3). For example: Current Expiry Date New Expiry Date (October 10, 2006) (April 4, 2007) (February 2, 2007) (August 8, 2007) Any product with an expiry date of April 4, 2007 or LATER reflects the new expiry dating and should be used by the date printed on the package. For example: Current Expiry Date New Expiry Date (April 4, 2007) Date printed on package (Sept 9, 2007) Date printed on package If you have any questions regarding the expiry dating of any PROCEED MESH product, please contact your sales representative.”
Davol Inc. A subdivision of C.R. Bard, Inc. Collamend Implant
Lot: DARA0082
Cat: 1175104 The Sigmoid colon resection was complete and they were suturing the abdomen. The mesh began to spontaneously split as they were suturing. The surgeon did not touch the mesh or cut it in any way. The mesh had to be removed which extended the length of the surgery.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel Hernia Patch 11.4 cm x 11.4 cm
Lot: 43DOD281
Other: REF 0010204 Patient experienced tenderness and continued bulging at graft placement site to reduce a hernia.



Additional Information:

Class I Recall: Bard Composix Kugel Extra Large Oval Patches. FDA Recall. January 24, 2007.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062944.htm

FDA Safety Information on Hernia Mesh Repair. October 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm#hernia


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