Reports were received that the device was fracturing and causing severe injuries to patients. These injuries included bowel perforations and obstructions.
Bard, and its subsidiary Davol, who manufactured the mesh, initially placed the blame for the difficulties on physician error. However, tests carried out by Davol showed a consistent failure in the device where the memory recoil ring was welded together. That is the most substantial recall available to the FDA and is used only for products considered dangerous or defective enough to cause serious health problems or even result in the death of the individual.
The Class I recall was updated in March , to include further lots of patches considered defective. The potential dangers are recognized by the FDA to be a result of a design defect that causes the memory ring to break. Symptoms of Problems with the Kugel Hernia Mesh.
If the memory ring on the patch breaks, it can cause intestinal injuries, including perforation of the bowel and chronic intestinal fistula. Being difficult to diagnose, doctors use a range of diagnostics tests to determine the condition.
These include:. Health professionals warn that in general, if the pain were accompanied by constant diarrhea, excessive seeping or constipation, it is an indication that things may be going wrong. These symptoms include: unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms. A malfunctioning hernia repair patch causes injuries that are often perceived as undignified, causing much embarrassment and discomfort to patients.
Often, patients feel uncomfortable discussing their injuries such as constipation, diarrhea, open wounds that are continuously seeping, with others. In effect, a simple laparoscopic hernia surgery that would have been quick and almost pain-free, confounds patients with a life altering condition, that causes immense physical and emotional suffering, and takes multiple surgeries over several years, to heal.
Please contact our San Antonio Kugel Mesh lawyers for a free review and consultation. The visual analog scale VAS was used to measure the severity of each patient's postoperative pain 11 Merskey H, Bogduk N. Part III: pain terms, a current list with definitions and notes on usage. The VAS of pain is usually shown on a cm horizontal line on which zero represents the absence of pain and 10 cm represents the most intense pain. The patient expressed their perception of the amount of pain that was felt by marking a horizontal line between two points.
The VAS score was measured in millimeters from the left end of the line to the point indicated by the patient. Various pre- and post-operative data details were recorded, including demographic data, body mass index, method of anesthesia, type of hernia direct or indirect , site of hernia, duration of operation, and the experience of the surgeon. Postoperative analgesic consumption was also recorded. The primary endpoints were the presence of postoperative groin pain 2 days, 3 months, 6 months, 12 months, and 18 months after the operation.
The visual analog scale VAS was used to measure the severity of postoperative pain. The secondary endpoints were operation time, complications e. The hypothesis was that clinical efficacy and safety of two kinds of meshes had no difference. Between March and December , a total of patients 78 males and 42 females with a mean age of In the end, patients were evaluated, of whom 60 received treatment with Swing mesh.
Figure 3 shows the flow diagram for the patients recruited into this study. There were no significant differences in the demographic variables between the allocated groups.
Additionally, the mean duration of the operation and the hernia characteristics were found to be similar in both groups Table 1. The majority of patients had surgery under epidural anesthesia and all patients did not experience intra-operative complications. Postoperative complications occurred in one patient in the study group foreign body sensation and in three patients in the control group infection at three months. However, the number of patients who had postoperative complications did not increase in the subsequent follow-up times, with parallel changes observed in both groups Table 2.
The early and late post-operative pain scores were similar between the allocated groups. The mean VAS for early postoperative pain was 1. No significant differences were found in the mean VAS scores between the two groups throughout the study period. None of the patients used any analgesic in the follow-up period. In terms of hernia recurrence, no case of recurrence was recorded in either of the groups during the month follow-up. The present randomized clinical trial study indicated that there were no significant differences in the pain score, recurrence, and complications between the two meshes when the same surgeon operated on the patients with the same surgical technique and anesthesia method.
However, it is worth noting that patients in the study group felt less foreign body sensation and underwent shorter operative time than did those in the control group. The Lichtenstein tension-free repair method was first introduced in 12 Amid PK. The Lichtenstein repair in an overview of causes of recurrence after Lichtensteintension-free hernioplasty. Rutkow then reported the satisfactory effect of tension-free repair of hernia ring fillings with polypropylene in However, postoperative chronic pain and foreign body sensation had become challenging issues.
To solve this problem, the Kugel posterior herniorrhaphy method, which was based on the Stopper operation, was introduced in 13 Unfortunately, the complicated posterior approach required additional time to master 14 Kugel RD. Minimally invasive, nonlaparoscopic, preperitoneal,and sutureless, inguinal herniorrhaphy. Zhou X. Comparison of the posterior approach and anteriorapproach for a Kugel repair of treatment ofinguinal hernias.
Inguinal hernia repair with the Kugel patch. ANZ J Surg. Inguinal hernia recurrence following preperitoneal Kugel patchrepair.
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