Trial reportHernia : the journal of hernias and abdominal wall surgery2013
Lessons and challenges during a 5-year follow-up of 21 Composix Kugel implantations.
Trial report in Hernia : the journal of hernias and abdominal wall surgery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- International guidelines for groin hernia management.Hernia : the journal of hernias and abdominal wall surgery · 2018Guideline
- Prophylactic mesh use during primary stoma formation to prevent parastomal hernia.Annals of the Royal College of Surgeons of England · 2017Pooled it
- Single-blind randomized clinical trial of transinguinal preperitoneal repair using self-expanding mesh patch vs. Lichtenstein repair for adult male patients with primary unilateral inguinal hernia.Hernia : the journal of hernias and abdominal wall surgery · 2021Trial
- Safety and tissue remodeling assay of small intestinal submucosa meshes using a modified porcine surgical hernia model.Scientific reports · 2024Article
- Transperineal Repair of Secondary Perineal Hernia Using a Mesh with a Memory-recoil Ring.Journal of the anus, rectum and colon · 2023Article
- A new semiresorbable mesh for primary inguinal repair: a preliminary observational study on quality of life and safety.Hernia : the journal of hernias and abdominal wall surgery · 2020Observational
- Risk-adjusted procedure tailoring leads to uniformly low complication rates in ventral and incisional hernia repair: a propensity score analysis and internal validation of classification criteria.Hernia : the journal of hernias and abdominal wall surgery · 2017Article
- Parastomal hernia and prophylactic mesh use during primary stoma formation: a commentary.Hernia : the journal of hernias and abdominal wall surgery · 2016Article
- [Indications for laparoscopic treatment of large incisional hernias].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2015Review
- False reduction of an inguinal hernia treated by Kugel patch repair via an anterior approach.BMC surgery · 2015Article
- Gentamicin for prevention of intraoperative mesh contamination: demonstration of high bactericide effect (in vitro) and low systemic bioavailability (in vivo).Hernia : the journal of hernias and abdominal wall surgery · 2014Article
- [Intervention-specific complications of hernia surgery].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFrom its introduction in 2000 until its US recall in December 2005, the Composix Kugel mesh was implanted in an estimated 350,000 patients worldwide. In our patients, minor postoperative complications were followed after a few years by more serious problems (persistent abdominal pain, infections, intestinal perforations). In this study, we take stock after a 5-year follow-up and issue a plea for improved product development strategies and the creation of hernia registries. PATIENTS AND
methodsBetween 2003 and 2006, we implanted the Bard(®) Composix(®) Kugel(®) mesh in 21 patients (11 men, 10 women, mean age 63.2 ± 13.7 years) with incisional hernias using the open intraperitoneal onlay mesh technique. The mesh is made on one side of ePTFE and on the other of polypropylene and is expanded by a polyethylene (PET) memory recoil ring. The average follow-up was 45.5 months. All patients had at least one risk factor for hernia recurrence. Explanted prostheses were analyzed by scanning electron microscopy (SEM) and subjected to mechanical strength tests.
resultsDuring the postoperative course, six patients suffered a wound healing disorder. Ten patients complained of persistent abdominal wall pain and four experienced recurrence of the hernia. In one patient, the mesh had to be explanted due to chronic infection. In one patient, the PET memory recoil ring broke after 5 years of follow-up with consequent small bowel perforation. The PET memory recoil ring exhibited clear signs of degradation on SEM and unmistakable signs of material fatigue in a materials testing machine.
conclusionsPatients with recalled Composix Kugel meshes face a singular risk for complications that may occur even many years after implantation. The most serious complication is the breakage of its PET memory recoil ring. Since the recall of the Composix Kugel Mesh, we have discontinued its use. It is necessary that future complications are documented in a common post-market surveillance registry. Algorithms need to be developed and promoted to support affected patients and surgeons.
Indexed as
Identifiers
23657860What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.