Next-gen surgical mesh to fill critical gap after regulatory ban

Next-generation urogynaecological surgical mesh implants are on the horizon for women suffering from pelvic organ prolapse (POP). This development aims to fill a critical clinical gap left after several medical devices were banned from the Australian market following the 2017 Senate Community Affairs References Committee inquiry.

POP is a debilitating yet often overlooked urogynaecological disorder that affects 25% of all women and up to 50% post-menopause. Management strategies include conservative approaches such as pelvic floor physiotherapy and vaginal pessaries, but surgical intervention remains necessary for up to 19% of affected women.

Historically, non-degradable polypropylene (PP) transvaginal mesh kits were widely used in reconstructive surgery to mitigate the failure of native tissue repair and reduce the risk of anatomical recurrence. However, these PP meshes led to severe complications, including mesh erosion, exposure, pain, and poor tissue integration – issues that ultimately outweighed their intended benefits.

As a result, regulatory bodies, including the Therapeutic Goods Administration (TGA), banned transvaginal PP meshes from medtech companies such as Johnson & Johnson, Boston Scientific, and Coloplast. With few innovative biomaterial solutions available, surgeons were forced to revert to native tissue and biologic graft techniques, which have shown high failure rates.

Now, a pioneering study by Hudson Institute researchers, Dr Kallyanashis Paul and Associate Professor Shayanti Mukherjee, has developed degradable mesh implants designed to regenerate vaginal tissue. Using a polymer material approved by the U.S. Food and Drug Administration (FDA), this research leverages advanced 3D printing techniques to create tissue engineering therapies for treating POP.

This world-first study introduces degradable melt electrowritten (MEW) vaginal implants for transvaginal pelvic floor reconstruction, offering a promising new frontier in POP surgical intervention.

“This study identified the simple geometrical attributes, namely, angle and porosity, to regenerate damaged tissue following childbirth injuries,” Dr Paul said. “Using layer-by-layer addition 3D printing technology, nine architecturally different meshes were fabricated to optimise the architecture that will allow the mesh’s degradation while boosting tissue integration.”

“One of the major issues caused by previous meshes was chronic foreign body response (FBR), which degenerates the vaginal tissue from re-growth. We have used preclinical models to test the various design factors required to make a mesh that the body will accept, not reject.”

The findings pave the way for next-generation alternative meshes.

Associate Professor Mukherjee highlighted the transformative potential of this research, saying “This study provides hope by developing customisable meshes that can boost native tissue repair, so the body will eventually reabsorb the mesh, leaving healthy new tissue and reversing the damage that POP can cause.”

Veteran stem cell biologist Professor Jerome Werkmeister echoed this enthusiasm. He stated, “We already know that our eMSC therapy (treatment with Mesenchymal Stem Cell (MSC)-derived extracellular vesicles) can modulate the immune response to mesh implantation.

“This research has found that the mesh geometry itself is also critical and can be designed and fabricated to promote tissue integration by orchestrating a favourable immune response. We believe this will enhance our endeavours towards clinical translation and hopefully commercialisation.”

For women like Sally Maconochie, who have personally experienced the devastating effects of POP, such advancements offer hope. Despite taking every precaution before the birth of her son, she suffered a traumatic birth injury, leading to partial levator avulsion, urinary incontinence, and both cystocele and rectocele prolapse. Her search for answers brought her to Hudson Institute.

“The critical thing is that nobody talks about it,” she said. “That’s why I am talking about it to anybody who will listen! I will forever talk to girls about the importance of avoiding constipation and actively caring for your body, your pelvic floor, and all of your female organs. I’ll forever remind people that women’s anatomy, ability, and longevity have suffered under a male-dominated medical system for too long, and that we need to get it out of the shadows of gender inequality.”

The research was financially supported by Hudson Institute of Medical Research, Johnson & Johnson, CSIRO, the National Health and Medical Research Council (NHMRC), and the Medical Research Future Fund (MRFF), among others.

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