MonoMax Suture: A New Long-Term Absorbable Monofilament Suture Made from Poly-4-Hydroxybutyrate

Abstract

A long-term absorbable monofilament suture was developed using poly-4-hydroxybutyrate (P4HB) made from a biosynthetically produced homopolymer of the natural metabolite 4-hydroxybutyrate. The suture, called MonoMax, has prolonged strength retention. At 12 weeks, a size 3-0 MonoMax suture retains approximately 50% of its initial tensile strength in vivo and is substantially degraded in one year with minimal tissue reaction. In contrast, PDS II monofilament suture (Ethicon, Inc., Somerville, NJ) has no residual strength in vivo after 12 weeks. In vivo, the MonoMax suture is hydrolyzed primarily by bulk hydrolysis, and is then degraded via the Krebs cycle. MonoMax is substantially more compliant than other monofilament sutures, and incorporates an element of elasticity. Its tensile modulus of 0.48 GPa is approximately one-third of the value of the PDS II fiber providing an exceptionally flexible and pliable fiber with excellent knot strength and security. These features are further enhanced by the fiber's elasticity, which also improves knot security and may help prevent wound dehiscence. Because of its performance advantages, this suture may find clinical utility in applications where prolonged strength retention, and greater flexibility are required, particularly in procedures like abdominal wall closure where wound dehiscence is still a significant postsurgical complication.

Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate—PHASIX Mesh) in a Porcine Model of Hernia Repair

“…This material has been manufactured into a number of configurations including the PHASIX Mesh and P4HB Plug, which are designed for soft tissue repair applications such as hernia repair. Over the last decade, P4HB materials have been evaluated in a number of animal studies, particularly those investigating cardiovascular applications such as tissue engineered trileaflet heart valves [24], artery augmentation patches [25], and small diameter vascular grafts [26], as well as development of P4HB as a suture material [27]. However, the current study is the first of its kind to evaluate this material specifically for hernia repair applications.…”

The potential of photoacoustic microscopy as a tool to characterize the in vivo degradation of surgical sutures

“…The prevalent mechanisms depend mainly on the water diffusion coefficient and the equilibrium water sorption of the polymer. In the case of Monomax (poly-4-hydroxybutyrate) it was observed during in vivo and in vitro studies that the absorption of the fibre is accompanied by a steady loss of the diameter of the Monomax fiber, which might indicate that the surface hydrolysis mechanism is predominant for this type of suture, though molecular weight analysis of the fiber remnants shows that also bulk hydrolysis is present [25, 26]. …”

Poly-4-hydroxybutyrate (P4HB): a new generation of resorbable medical devices for tissue repair and regeneration

“…Odermatt et al have reported extensive testing of P4HB polymer and P4HB suture fibers [19]. The biomaterial shows excellent biocompatibility and passed tests for cytotoxicity, irritation and sensitization, systemic toxicity, genotoxicity, subchronic and chronic implantation, and hemolysis.…”

“…FDA clearance of a monofilament surgical mesh followed in the same year, and to date, there have been 15 products cleared for use in the USA (see Table 4). In addition, a P4HB monofilament suture sold under the trade name of MonoMax ® received regulatory clearance in Europe through a CE Mark in 2009 [19]. The products cleared for human use include: (i) suture sizes from size 2 to size 5/0, dyed suture, and films for use in Table 4, the MonoMax suture was developed with a higher degree of elasticity in order to confer some specific benefits on the MonoMax suture for abdominal wall closure.…”

“…The first commercial P4HB product to be launched was the MonoMax suture [19]. The product was initially launched in 2009 in Germany by B. Braun Surgical, and is now available throughout most of Europe, and has been recently released in the US and several other countries.…”