In a March 24, 2006 letter notifying hospitals and surgeons of the expanded Bard Composix Kugel Patch recall, Davol, Inc. noted that it had received 31 reports of broken memory recoil rings in extra large Kugel patches out of a total of 29,000 patches sold (a rate of 0.109%). Those 31 cases included:
“11 cases where the broken ring migrated into or through the patient’s abdominal wall, with associated infection in 2 cases.”
“1 case where the ring reportedly migrated into the vagina.”
“7 cases of bowel perforation reported in association with a broken ring.”
“1 case of bowel obstruction, which was repaired without removal of the mesh (causality to the broken ring has not been clearly established in this case).”
“1 reported death where the patient reportedly developed septic shock, consumptive coagulopathy and acute myocardial infarction after surgery to repair small and large bowel fistulas reportedly caused by perforation by the broken ring.”
When the recall was expanded to large size patches in January 2007, Davol noted in its letter to hospitals and surgeons that six reports of broken rings had been received for this product out of 25,835 manufactured for a rate of 0.029%. The letter noted that:
“1 Incident occurred during the mesh placement surgery and the product was not implanted.”
“1 incident of a broken ring was noted at the time of surgery and the ring was removed but the mesh was left implanted. No patient symptoms have been reported following this procedure.”
“1 incident was reported where a broken ring had migrated into the abdominal wall and was removed, leaving the mesh implanted.”
“1 incident was reported where the mesh was explanted as a response to reported abdominal pain and a broken ring was noted.”
“Two (2) inconclusive incidents were reported where bowel perforation and broken rings were noted at the time of explant.”
MAUDE Reports
The FDA maintains a database of adverse event reports for medical devices known as the Manufacturer and User Facility Device Experience (MAUDE) Database. A search of this database revealed 1480 entries containing the word “Kugel.” Some of the entries were made by Davol, Inc based on reports it had received by telephone or in writing. Other entries were submitted directly to the FDA by medical personnel or patients.
A large percentage of the MAUDE reports sampled contain too little information to make any determination as to whether the event was attributable in any way to the Kugel patch. For example:
“A male had a portion of a plastic substance removed during a procedure. He previously had a bard composix kugel large oval implanted in 2004.”
“Attorney’s report of pt’s alleged ’surgical procedure to remove a malfunctioning recalled kugel mesh’.”
(Editor’s Note: “pt” is an abbreviation for “patient.”)
“Patient had laparoscopic ventral hernia repair with mesh implant in 2005. Patient had exploratory.”
“Attorney’s report of patient’s alleged abdominal pain, ‘that the kugel patch had managed to become bent and out of shape and was binding’ the patient’s intestines.”
“Patient developed an abcess (sic) after surgery to repair an incarcerated and strangulated recurrent upper abdominal ventral hernia, giant.”
Additionally, many reports are not at all related to defects in the memory recoil ring.
“Pt had a laparoscopic nephrectomy done by a hand port incisional hernia. The defect was initially repaired with a kugel mesh device. Postoperatively, the pt gained 30 pounds, in about one year time frame and had a recurrence of the previous hernia.”
“It was reported by the pt that she had a hernia repair with subject product in ‘07. In ‘08, the patch was removed because of an infection. Her stomach has been swollen since the initial surgery.”
The database also contains records that ultimately report nothing.
“Had 2 surgeries for hernia’s after a major surgery. They placed the bard composix kugel mesh inside me for the second surgery and had complained and visited the surgeon several times complaining about abdominal pains and swelling in the effected area. Had 2 cat scans with what the doctor called negative results for a new hernia, but nothing about the swelling and pain that i had. I heard about the recall for the mesh and after checking, i had one of the recalled meshes inside of me. Product code 0010208 lot number 43cptd365. Confirmed with bard about being part of the recall by the company, but was never notified, by either the company or the hospital, nor the doc’s office.”
“Had the bard composix kugel patch implanted to repair hernia in dec. 2003. Just heard of recall, called dr’s office -surgeon who repaired hernia-. Office claims never heard of recall. This scares me as i have this mesh in me and my doctor is not even aware there is a problem. Shouldn’t he be told and brought up to date? thank you.”
Some of the reports are clear, however.
“Six months post-op pt presented with infection. During removal of mesh surgeon found that memory recoil ring had broken and punctured pt’s bowel.”
“The memory ring broke and perforated the small intestines of the famle (sic) pt. The mesh was implanted in 2005 and explanted in 2006. The mesh was discarded after explantation. The operation site has been sutured twice already and the pt’s condition is critical, but stable at the present time.”
“Broken ring-perforated small bowel and colon causing fistula.”
“Patient had kugel mesh explanted due to broken ring. Unsure when mesh was implanted.”
“Broken recoil ring. Perforated bowel and fistula. Implanted in 2004 at different hospital. In 06 – new information from sales rep: mesh implanted by same surgeon, dr. Who also did the explant.”
“Mesh implanted in 2005. Removed 4 mos later. Patient felt pain from a foreign body. Ring had penetrated the subcutaneous tissue beneath the skin.”
Challenges in Event Tracking
During the most recent review of data, broken memory recoil rings have been responsible for approximately 80 confirmed injuries and at least one death compared to at least 1480 adverse event reports in the MAUDE database alone. The challenge of finding these serious problems in a mountain of often-superfluous data clearly demonstrates the difficulty in tracking medical device complaints effectively.
According to the FDA’s investigation of Davol, Inc. after the recall, the degree to which they were unable to process the complaints accurately to discover the real problems with the large Kugel patches may have had a significant effect on why it took the company so long to recall them.
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