The Role of Bioactive Prosthetic Material for the Treatment of Sports Hernias


Mesh name

Vendor

Source

Cross-linking

Sterilization

AlloDerm®

LifeCell

Human dermis

No

None

AlloMax®

Bard/Davol

Human dermis

No

Gamma irradiation

CollaMend™

Bard/Davol

Porcine dermis

Yes

Ethylene oxide

FlexHD™

Ethicon

Human dermis

No

None

FortaGen®

Organogenesis

Porcine intestine

Yes

Gamma irradiation

MatriStem®

ACell

Porcine bladder

No

E-beam

Peri-Guard®

Synovis

Bovine pericardium

Yes

Liquid alcohol

Permacol™

Covidien

Porcine dermis

Yes

Gamma irradiation

Strattice®

LifeCell

Porcine dermis

No

E-beam

SurgiMend®

TEI Biosciences

Fetal bovine dermis

No

Ethylene oxide

Surgisis®

Cook Medical

Porcine intestine

No

Ethylene oxide

Tutopatch®

Tutogen Medical

Bovine pericardium

No

Gamma irradiation

Veritas®

Synovis

Bovine pericardium

No

E-beam

XenMatrix®

Bard/Davol

Porcine dermis

No

E-beam



Nevertheless, the technique described is worthy of further discussion and investigation. The author has shown good preliminary results. We look forward to larger population and longer-term data. It would be useful to know if other forms of collagen matrices would also show benefit when implanted in this region and also which specific patients are best candidates to undergo this type of approach for their athletic pubalgia.



Introduction


The use of mesh in the repair of hernias is commonplace. Synthetic meshes such as polypropylene and polyester have been the standard for hernia repairs since the 1980s. Biologic graft material composed of purified porcine small intestinal submucosa was first introduced to the United States in 1998, as an alternative to synthetic biomaterials. These meshes, composed of extracellular matrix (ECM) collagen, fibronectin, associated glycosaminoglycans, and growth factors [14], have been extensively investigated in animal models [57] and used clinically in many types of surgical procedures. Referred to as bioactive prosthetic materials (BPM ) , they are considered a scaffold for the binding of growth factors and other cellular elements for the healing response. The subsequent healing response and strength are dependent on ingrowth from the patient’s cells and blood vessels into the ECM of the BPM. Fibrin may assist this ingrowth and thus may be added extrinsically as topical fibrin sealant [8]. The balance between ECM synthesis and degradation contributes to the ultimate success of the hernia repair.

Surgisis (Cook Surgical, Bloomington, IN) was the first biologic graft material to be marketed in the United States. I began using it in my practice for hernia repairs and reported my initial results in Surgical Technology International XV in July 2006 [9]. Since then, there have been many more reports using BPM, acellular dermal matrices, and other biologic materials for hernia repair. The aim of this chapter is to review the topic of BPMs and their application to inguinal hernia and sports hernia repairs.


Basic Differences in Bioactive Prosthetic Materials


Table 27.1 summarizes the BPMs currently on the market in the United States. They differ based on their mammalian source (animal or human), tissue of origin (dermal, pericardial, bladder, or intestinal submucosa), as well as their methods of processing (cross-linked or not cross-linked) and sterilization. All of these differences may lead to differences in the healing process and thus clinical outcome. With the exception of AlloDerm®, Surgisis®, and StratticeTM, peer-reviewed studies outlining the clinical outcome from implantation of biologic tissue is significantly lacking.

Mammalian source may be considered when choosing among the various BPMs available. Human cadaveric tissues offer the advantage of using allograft (within species) sourcing and thus lacking interspecies rejection risk. The source of such tissues is donor dependent, with variability in composition, health, thickness, and age of the tissue. Additionally, there is risk of disease transmission within species; indeed, there have been reports of disease transmission in human cadaveric allograft products of the dura mater in Japan from the 1990s [10].

Alternatively, animals can be raised to precise specifications to achieve a more consistent product. The risk of allergic response to their ECM is low because of the high homology with similar human proteins. With nonhuman tissues, the risk of tissue rejection remains despite decellularization, as does the rare possibility of disease transmission. The specifics of each biologic material should be known prior to implantation, especially when treating certain populations. For example, an immune-compromised patient may be at higher risk if undergoing implant with a human cadaveric allograft that is not sterilized. Similarly, an atopic patient may be at higher risk of allergic response to a xenograft.

BPMs vary in their tissue of origin. The dermis remains the preferred tissue source, though products made from alternative tissues, such as the pericardium, stomach, bladder, and intestinal submucosa, are also available. There is not enough literature to compare differences in clinical outcomes across different tissues of origin. All tissue sources contain significant amounts of collagen and other ECM proteins. However, some tissues such as the pericardium and intestinal submucosa lack the protein elastin, a significant component of the dermis that gives skin its elasticity. Elastin has been theorized to cause in vivo stretching of the allograft, resulting in diastasis after bridged repair of ventral hernia [11, 12]. At the same time, the elasticity of dermis-based grafts is favorable when implanted in areas where tissue pliability is necessary, such as in breast reconstruction following mastectomy. Thus, the tissue of origin may be a significant factor to consider when choosing the best BPM for the procedure of interest.

Lastly, BPMs are either purposely cross-linked or non-cross-linked at the time of their processing. Cross-linking is a way of stabilizing the graft and making it more resistant to tissue-degrading enzymes and bacteria that break down collagen. While this process may increase the durability of the graft [13], clinical studies have shown that the majority of adverse events associated with hernia repair grafts have occurred with cross-linked products [14]. These complications included acute mechanical failure of the mesh, degradation of the mesh, and poor integration of the mesh. Poor mesh integration is a result of poor angiogenesis into the material, which can lead to encapsulation or prolonged inflammatory response characterized by foreign body giant cell reaction. Recent findings suggest that cross-linking does not necessarily translate to durability, and, while there may yet be a place for cross-linked materials in hernia repair, cross-linked materials need to be used with caution until the optimal degree of cross-linking to overcome these complications can be understood [15].


BPM and Inguinal Hernia Repair


One of the first studies reporting the use of BPM in humans was reported in 2002 [16]. This was a preliminary study on 15 inguinal hernias in 12 patients. The preliminary results were good with no recurrences at 1 year and no chronic pain. Since then, there have been multiple studies demonstrating positive results after inguinal hernia repair with biologic tissue. Fine repaired 51 hernias in 38 patients with BPM mesh and fibrin sealant [17]. He showed no major complications, one recurrence at 13 months, and chronic pain in three patients (7.9 %). This is lower than what is typically reported with synthetic mesh after open repair, at approximately 12.5 %. We reported our results in 2008, using fibrin sealant alone to laparoscopically secure BPM and polypropylene mesh in comparable groups of 18 patients with 23 repairs [18]. The results were similar in both groups with no long-term chronic pain or hernia recurrences. The biologic group had a few patients with short-term (less than 3 months) groin discomfort. Lastly, in Italy in 2008, Agresta and Bedin reported 11 patients undergoing laparoscopic TAPP hernioplasty with BPM and fibrin sealant [19]. There was one technical error leading to a recurrence at 14.5 months, and there were no reports of chronic pain. He hypothesized for use of BPM in the young patient, where there is a fear of leaving behind a foreign body in the long term.

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Oct 21, 2016 | Posted by in PAIN MEDICINE | Comments Off on The Role of Bioactive Prosthetic Material for the Treatment of Sports Hernias

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