Patient perspectives on mesh-related complications after hernia repair

Hooper, Madison; Renshaw, Savannah; Poulose, Benjamin K.

doi:10.1016/j.surg.2021.09.022

Cited by 6 publications

(5 citation statements)

References 30 publications

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“…On follow-up, two patients (2.41%) had a mesh-related complication, 'mesh-feeling', which did not influence the patient's quality of life or daily activities. Little is known about such experiences of patients and further studies are needed (24). We identified one patient with hydrocele (1.2%), another one with chronic groin pain (1.2%) and a third one with recurrence (1.2%), which was in agreement with the literature (25,26).…”

Section: Discussionsupporting

confidence: 89%

Surgical Outcome in Bilateral Inguinal Hernia Repair: Laparoscopic Total Extraperitoneal Approach (TEP) as Best Approach?

UNGUREANU,

GINGHINA,

STANCULEA

et al. 2023

Maedica

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Introduction: Bilateral inguinal hernia is a distinct entity in the inguinal hernia category. Open and minimally invasive techniques for the treatment of bilateral inguinal hernia have been previously described. If resources and surgeon expertise are available, guidelines recommend laparoscopic repair for this entity. Methods: We analyzed data from 83 patients who underwent laparoscopic inguinal hernia repair (total extraperitoneal repair -TEP) of 158 hernias (146 inguinal hernias and 12 other types). Patients had bilateral symptomatic hernias.Results: Male predominance, with a mean age of 56.7 years, was noted. Lateral hernias (according to EHS classification) were prevalent (71.08%). In the majority of cases (77.11%), meshes made up of a custom polypropylene monofilament mesh were used, followed by Bard 3D Max mesh and Ultralight mesh. Regarding postoperative complications, seroma was the most frequently encountered one in our series (7.23%), followed by urinary retention and 'feeling' of mesh (2.41%). Hydrocele, wound hematoma, cord hematoma and chronic

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Section: Discussionsupporting

confidence: 89%

Surgical Outcome in Bilateral Inguinal Hernia Repair: Laparoscopic Total Extraperitoneal Approach (TEP) as Best Approach?

UNGUREANU,

GINGHINA,

STANCULEA

et al. 2023

Maedica

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“…Furthermore, recurrence as the main clinical parameter of IHR success fails to encompass other patientcentered measures and exposes the need for routine incorporation of long-term patient-reported outcomes, which have been shown to have a devastating effect on quality of life when they occur. 8 Further research is warranted to specifi- cally determine how the risk conferred by mesh footprint is modified by type of mesh, tissue plane, and wound class as a proxy of the degree of contamination as this information will likely aid surgeons with their mesh choice. These data will be particularly useful for surgeons performing IHR in younger patients with higher risk for wound healing issues or those more likely to undergo subsequent abdominal procedures.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, our results suggest that the decreased IH recurrence benefit conferred by prosthetic reinforcement of the abdominal wall may be further counterbalanced not only by mesh-related complications after IHR but by the aforementioned adverse outcomes and increased longitudinal health care utilization at the time of a future abdominal surgical procedure. Furthermore, recurrence as the main clinical parameter of IHR success fails to encompass other patient-centered measures and exposes the need for routine incorporation of long-term patient-reported outcomes, which have been shown to have a devastating effect on quality of life when they occur . Further research is warranted to specifically determine how the risk conferred by mesh footprint is modified by type of mesh, tissue plane, and wound class as a proxy of the degree of contamination as this information will likely aid surgeons with their mesh choice.…”

Section: Discussionmentioning

confidence: 99%

“…4,6 Nonetheless, although mesh confers a protective benefit against IH recurrence, long-term complications, including reoperations, are a concern in these patients. 7 Recent literature 8 has even explored how patients experience long-term meshrelated complications and has determined that these complications are not well understood. There are barriers in communication of these complications between patients and clinicians.…”

mentioning

confidence: 99%

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Reoperation Through a Prosthetic-Reinforced Abdominal Wall and Its Association With Postoperative Outcomes and Longitudinal Health Care Utilization

et al. 2022

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ImportanceProsthetic reinforcement of critically sized incisional hernias is necessary to decrease hernia recurrence, but long-term prosthetic-mesh footprint may increase complication risk during subsequent abdominal operations.ObjectiveTo investigate the association of prior incisional hernia repair with mesh (IHRWM) with postoperative outcomes and health care utilization after common abdominal operations.Design, Setting, and ParticipantsThis was a population-based, retrospective cohort study of patients undergoing inpatient abdominal surgical procedures during the period of January 2009 to December 2016, with at least 1 year of follow-up within 5 geographically diverse statewide inpatient/ambulatory databases (Florida, Iowa, Nebraska, New York, Utah). History of an abdominal operation was ascertained within the 3-year period preceding the index operation. Patients admitted to the hospital with a history of an abdominal operation (ie, bariatric, cholecystectomy, small- or large-bowel resection, prostatectomy, gynecologic) were identified using the International Classification of Diseases, Ninth Revision and Tenth Revision, Clinical Modification procedure codes. Patients with prior IHRWM were propensity score matched (1:1) to controls both with and without a history of an abdominal surgical procedure based on clinical and operative characteristics. Data analysis was conducted from March 1 to November 27, 2021.Main Outcomes and MeasuresThe primary outcome was a composite of adverse postoperative outcomes (surgical and nonsurgical). Secondary outcomes included health care utilization determined by length of hospital stay, hospital charges, and 1-year readmissions. Logistic and Cox regression determined the association of prior IHRWM with the outcomes of interest. Additional subanalyses matched and compared patients with prior IHR without mesh (IHRWOM) to those with a history of an abdominal operation.ResultsOf the 914 105 patients undergoing common abdominal surgical procedures (81 123 bariatric [8.9%], 284 450 small- or large-bowel resection [31.1%], 223 768 cholecystectomy [24.5%], 33 183 prostatectomy [3.6%], and 291 581 gynecologic [31.9%]), all 3517 patients (age group: 46-55 years, 1547 [44.0%]; 2396 majority sex [68.1%]) with prior IHRWM were matched to patients without a history of abdominal surgical procedures. After matching, prior IHRWM was associated with increased overall complications (odds ratio [OR], 1.43; 95% CI, 1.27-1.60), surgical complications (OR, 1.51; 95% CI, 1.34-1.70), length of hospital stay (mean increase of 1.03 days; 95% CI, 0.56-1.49 days; P &lt; .001), index admission charges (predicted mean difference of $11 896.10; 95% CI, $6096.80-$17 695.40; P &lt; .001), and 1-year unplanned readmissions (hazard ratio, 1.14; 95% CI, 1.05-1.25; P = .002). This trend persisted even when comparing matched patients with prior IHRWM to patients with a history of abdominal surgical procedures, and the treatment outcome disappeared when comparing patients with prior IHRWOM to those without a previous abdominal operation.Conclusions and RelevanceReoperation through a previously prosthetic-reinforced abdominal wall was associated with increased surgical complications and health care utilization. This risk appeared to be independent of a history of abdominal surgical procedures and was magnified by the presence of a prosthetic-mesh footprint in the abdominal wall.

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“…This benefit is offset by mesh-related complications including chronic pain, infection, bowel obstruction, and fistulization [3]. Concern about safety and effectiveness of mesh used in hernia repair has been documented in published literature, regulatory action, and litigation [4][5][6]. Weaknesses in effective post-market surveillance of hernia mesh and related products are also well understood [7,8].…”

Section: Introductionmentioning

confidence: 99%

Determining the value of the abdominal core health quality collaborative to support regulatory decisions

Poulose,

Avila-Tang,

Schwartzman

et al. 2024

Hernia

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Purpose The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. Methods Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. Results 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. Conclusions Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

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Patient perspectives on mesh-related complications after hernia repair

Cited by 6 publications

References 30 publications

Surgical Outcome in Bilateral Inguinal Hernia Repair: Laparoscopic Total Extraperitoneal Approach (TEP) as Best Approach?

Surgical Outcome in Bilateral Inguinal Hernia Repair: Laparoscopic Total Extraperitoneal Approach (TEP) as Best Approach?

Reoperation Through a Prosthetic-Reinforced Abdominal Wall and Its Association With Postoperative Outcomes and Longitudinal Health Care Utilization

Determining the value of the abdominal core health quality collaborative to support regulatory decisions

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