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parietex surgical mesh modified into parietex hydrophilic 2d 3d anatomical mesh parietex composite mesh pco and pco-os references parietex optimized composite mesh pco-x pco-fx and pco-osx references
Sofradim Production
Summary: Parietex surgical mesh is used for hernia repair and other surgical applications. It is FDA 510k cleared and supported by evidence from 6 studies, highlighting its efficacy and safety profile.
FDA Clearance Information
Pathway
510K
Number
K173796 ↗
Decision Date
March 9, 2018
Product Code
FTL
Device Class
Class 2
Evidence
419 studies
The Parietex surgical mesh, manufactured by Sofradim Production, received FDA clearance through the 510k pathway on March 9, 2018. It is classified as a Class 2 medical device.
What It Is
Parietex surgical mesh is a medical device designed for use in hernia repair and other surgical procedures. It features a hydrophilic coating that enhances tissue integration and reduces adhesion formation.
Clinical Applications
Commonly used in laparoscopic and open hernia repair surgeries, Parietex mesh is applied in scenarios such as inguinal and parastomal hernias. It is designed to provide durable support and facilitate healing.
Evidence Summary
The literature includes 6 studies, ranging from 2015 to 2024, encompassing various study designs such as prospective cohorts and case series. These studies evaluate the mesh's performance in different surgical contexts.
Reported Outcomes
Published studies report that Parietex mesh is effective in reducing hernia recurrence rates and allows for early return to normal activities. Specific outcomes include minimal discomfort and successful pregnancy outcomes post-repair.
Safety Profile
Reported complications include seroma formation, which was managed conservatively. Other studies noted technical errors and partial shrinkage of the mesh as causes for recurrence.
Evidence Limitations
The evidence base is limited by the small number of studies and variability in study design. Further research is needed to establish long-term outcomes and compare efficacy with other mesh types.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Parietex surgical mesh?
Parietex mesh is indicated for use in hernia repair surgeries, including inguinal and parastomal hernias.
What outcomes have been reported in clinical studies?
Studies report reduced recurrence rates, minimal discomfort, and successful surgical outcomes.
What complications have been reported?
Safety data indicate seroma formation and technical errors as complications, with conservative management being effective.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.