That same year, the FDA issued a Class I recall and safety investigation of counterfeit surgical mesh. Four hernia mesh products were recalled when the FDA discovered that they were counterfeit products stamped with C. Bard product codes. The fake hernia mesh was not made from approved material and in some instances, was not even sterilized.
RAM Medical, Inc. The distributors, in turn, sold them to hospitals and surgery centers. The FDA urged both patients and doctors to check for matching product codes of the recalled devices. The devices were recalled after reports that the coated mesh did not perform well when exposed to high humidity. This time, the recall was voluntary and concerned products containing Physiomesh flexible composite mesh. Patients had a higher rate than normal of hernia recurrence using the defective mesh.
The company's Versatex monofilament mesh were found to be unsafe because of an abnormal number of hernia recurrence. Patients who had the recalled Versatex mesh were forced to have additional surgery.
Your hernia mesh product code may or may not match the products listed on the FDA recall web pages. If you have any of the following symptoms of hernia mesh failure, seek medical attention right away:.
In the right patients, some groin hernias can be repaired without mesh and still have acceptable success rates. Additionally, some small hernias at the belly button can be repaired with suture alone.
Most repairs, though, do utilize prosthetic mesh to achieve a successful repair. A: The term "mesh" is used to describe a flat sheet of prosthetic material that is used to cover, or "patch," a hernia. A: There is a sizable industry devoted to a large array of hernia meshes. Some are made of various plastics; some are made of biologic materials. Some are permanent and some are designed to degrade over time.
The most common type of mesh is made of a plastic material and closely resembles a window screen in appearance. Some meshes are also made with protective coatings that allow them to be placed in the abdomen near the abdominal organs. A: Decades ago, hernia repairs were performed by simply suturing the hernia closed. Mesh changed that. By using mesh, the chance of hernia recurrence dropped to the low single-digits.
A: In most cases, using mesh is the acceptable standard of care. However, there can certainly be complications related to the mesh. A: Mesh is a foreign body that your body incorporates to help strengthen the repair. However, being a foreign body, it can also become infected if it becomes contaminated either at the time of surgery or later. This may require mesh removal. Mesh placed inside the abdomen can also lead to scar tissue, or adhesion, formation that can predispose patients to bowel obstruction down the road.
However, all patients who have had surgery in the abdomen also form these adhesions, so this is not a problem specific to the mesh itself. Journal List Membranes Basel v. Membranes Basel. Published online Aug Author information Article notes Copyright and License information Disclaimer. Received Jun 15; Accepted Aug This article has been cited by other articles in PMC. Abstract Surgical meshes, in particular those used to repair hernias, have been in use since Keywords: surgical mesh, hernia repair, abdominal wall reconstruction, biocompatibility.
Introduction A hernia is defined as a protrusion or projection prolapse of an organ through the wall of the cavity where it is normally contained [ 1 ]. History In , Theodor Billroth suggested that the ideal way to repair hernias was to use a prosthetic material to close the hernia defect [ 12 ]. Current Research on Surgical Meshes Most surgical meshes used currently are chemically and physically inert, nontoxic, stable and non-immunogenic.
Elasticity and Tensile Strength A deterioration of the tensile strength of the mesh or a strained mesh could potentially lead to hernia recurrence or a poor functional result. Pore Size Porosity plays a key role in the reaction of the tissue to the prostheses. Constitution Surgical meshes could be fabricated using monofilament or multifilament twisted systems. Material Absorption Surgical meshes could be made from an absorbable or non-absorbable material. Commercially Available Surgical Meshes The ideal mesh should be able to be held in situ by peripheral sutures, resist the possibility of loading under biaxial tension coughing or lifting actions without failure especially during the early postoperative period, and should promote a fast and organized response from fibrous tissue with minimal inflammation [ 3 ].
First Generation Meshes First generation surgical meshes are predominantly based on polypropylene PP systems. Table 1 Classification of commercially available first generation surgical meshes [ 38 ]. Eliminates the risk of infectious disease transmission. Usually results in hernia recurrence after complete absorption Dexon Syneture Polyglycolic acid 0.
Adhesions fade as the mesh is absorbed. It is controversial whether the fibrous ingrowth into the prosthesis is sufficient to accomplish a permanent repair. Sefil B-Baun Polyglycolic acid 0. High anatomic adaptability and low risk of late secondary infection.
Evokes a chronic inflammatory reaction. Reduced patient pain. Adhesions risk. Prolene Ethicon PP 0. Surgipro Autosuture PP 0. Difficult complete wound healing caused by mesh structure. Prolite Atrium PP 0. Trelex Meadox PP 0. Premilene B-Braun PP 0. Serapren smooth PP 0.
Not used in intraperitoneal spaces as produce dense adhesions. Optilene B-Baun PP 1. Ideal for inguinal hernia repair to reduce chronic pain. Not used in extraperitoneal spaces as produce dense adhesions. Mersilene Ethicon POL 1. Evokes an aggressive macrophage and giant cell rich inflammatory reaction, followed by a dense fibrous ingrowth. Open in a separate window.
Second Generation Meshes Despite the improvements made within the first generation meshes Table 1 , which include high tensile strength in order to support intra-abdominal pressure, several complications such as hernia recurrence, infection, and adhesions still prevailed.
Table 2 Classification of commercially available second generation surgical meshes [ 38 ]. Higher rate of hernia recurrence. Infection risk. Minimizes adhesions and provides optimal tissue ingrowth. Risk of formation of visceral adhesions. Reduces adhesions and the optimal tissue ingrowth is promoted. Sticky consistency difficult the surgeon manipulation.
Low tensile strength. No significant difference for adhesion grade or amount relative to other meshes. Third Generation Meshes Even with the improvements made on the second generation meshes Table 2 where composite systems were designed to maintain the mechanical stability of first generation meshes Table 1 and reduce inflammation and infection risk by mesh surface modification, the problems encountered with second generation meshes, such as the prevalence of adhesions, led to the development of biologic prostheses.
Table 3 Classification of commercially available third generation surgical meshes [ 38 ]. Long history of safety data. Requires hydration. Susceptible to collagenases. AlloMax Davol Human acellular dermis 23 No refrigeration or rehydration is required. Available in large sizes. Hydration required. Limited long-term follow up. Information not available in literature.
Manufacturing Processes for Surgical Meshes Surgical meshes are produced from different synthetic materials and in different mesh structures, the knitted structure being the most common [ 44 ].
The Extrusion Process Melt extrusion is the least expensive and simplest form of fiber extrusion [ 47 ]. Filaments used for surgical sutures have to possess several characteristics such as [ 53 ]: Ability to attach to needles by the usual procedure. Capability to be sterilized using ethylene oxide or ultraviolet radiation. Ability to pass easily through tissue. Ability to resist breakdown without developing an infection. Possess minimal reaction with tissue.
Maintain its in vivo tensile strength over extended periods. The Knitting Process During the knitting process, fibers or yarns are curved to follow a meandering path and not oriented unilaterally as in weaving; therefore, the resulting fabric tends to be much more flexible and elastic than woven fabrics.
Figure 1. Table 4 Classification of commercially available surgical meshes [ 59 ]. Future Perspectives Despite the clinical success and vast body of knowledge that has been gained regarding manufacturing of surgical meshes, material properties, and surgical procedures, it is obvious that the ideal mesh has not been developed. Coatings A variety of biocompatible and biodegradable natural and synthetic polymers are being investigated.
Table 5 Material properties of surgical mesh coatings. Table 6 Examples of surgical mesh coating parameters. Nanofibers Nanofiber systems made from a large variety of materials have been explored extensively in the last decade.
Table 7 Nanofiber based surgical meshes. Lack of in vivo testing. No fulfill the mechanical requirements. Bioresorbable polymer. Exceed the minimum mechanical requirements for hernia repair applications. No evidence of intestinal adhesions. Trigger of a large foreign body reaction. Table 8 Aspects related to hernia meshes compared in recently published reviews. Baylon et al. This Review Brown et al. Biomaterial meshes 10 meshes Comparison between synthetic meshes 15 meshes Comparison between composite meshes 12 meshes Meshes divided by Biologically Derived Matrices, Biodegradable synthetic structures, Anti-inflammatory mesh, Meshes with enhanced cytocompatibility, Anti-adhesive Mesh, Antibacterial meshes.
Review also discusses mesh fixation, self-expanding systems, post-implantation visible mesh, cell coated meshes, and growth factor loaded meshes. Comparison between Multilayered Meshes 10 meshes Total meshes compared 35 27 27 - 24 Conclusions Surgical meshes have become the system of choice for hernia repair.
Author Contributions As a review article, all authors contributed to the writing, editing and revision of the manuscript. Conflicts of Interest The authors declare no conflict of interest. References 1. Williams L. Understanding Medical-Surgical Nursing. Dabbas N.
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