Two Studies Evaluate OviTex Reinforced BioScaffolds for Hernia and Soft Tissue Repair

MedicalResearch.com Interview with:

Maarten Persenaire, MD Co-founder, Chief Medical Officer TELA Bio

Dr. Persenaire

Maarten Persenaire, MD
Co-founder, Chief Medical Officer
TELA Bio

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: OviTex Reinforced BioScaffolds (RBSs) are a novel distinct class of surgical implants that combine biologic and synthetic materials in a unique embroidered construction and design for hernia repair and soft tissue reconstruction. The two recent publications reported clinical results of OviTex RBS performance in inguinal and hiatal hernia repair.

Case series published in the International Journal of Surgery Open evaluated the role of OviTex RBSs in inguinal hernia repair to reduce the incidence of chronic postoperative pain. Thirty-one consecutive patients who had inguinal hernia repaired with OviTex RBSs were followed for an average of 12.6 months, during which time there were no reported recurrences, complications requiring surgical intervention or infections. None of the patients reported postoperative inguinal pain beyond the first days after surgery and none required a narcotic pain medication refill.

The second study published in the Journal of the Society of Laparoendoscopic Surgeons is the first reported series describing the use of OviTex RBSs in hiatal hernia repair. A retrospective chart review of 25 consecutive patients undergoing laparoscopic or open hiatal hernia repairs with mean follow-up of 14.2 months showed no recurrences. The hiatal hernia repairs with OviTex RBSs resulted in good to excellent control and resolution of symptoms, including heartburn, dysphagia, regurgitation, nausea and vomiting, dyspnea, and chest pain or discomfort.  Continue reading

OviTex Reinforced BioScaffolds Combine Synthetic and Biologic Materials For Soft Tissue Repair

MedicalResearch.com Interview with:

Michael Sawyer, MD, FACS General Surgeon Comanche County Memorial Hospital Lawton, Oklahoma

Dr. Michael Sawyer

Michael Sawyer, MD, FACS
General Surgeon
Comanche County Memorial Hospital
Lawton, Oklahoma 

MedicalResearch.com: What is the background for this study?

 

Response: Repair of complex incisional hernias is a challenging surgical task. Abdominal wall surgeons are utilizing advanced abdominal wall reconstruction (AWR) techniques including myofascial advancement flap creation with reinforcement by biologic or synthetic prostheses with greater frequency.

Numerous synthetic or biologic surgical mesh products are currently available to reinforce these soft tissue repairs. Each type of biologic or synthetic material has its own advantages and limitations.

OviTex Reinforced BioScaffolds (RBSs) are unique in that they interweave polymer in a custom “lock-stitch” pattern through layers of biologic tissue in an embroidered construction, aiming to incorporate the salutary properties of both biologic and synthetic repair materials. The biologic material, derived from ovine rumen, has been optimized to minimize foreign body response and enables functional tissue remodeling. The polymer provides additional strength, along with improved handling and load‑sharing capability.

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Hernias Repaired With Mesh Have Lower Risk of Re-Operation

MedicalResearch.com Interview with:
Thue Bisgaard, M.D., D.M.Sc

Professor of Surgery,
Hvidovre Hospital
Hvidovre Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The complete spectrum for the benefits and risks of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization.

Generally, there is evidence that mesh is beneficial in terms of less risk of reoperation for recurrence after incisional hernia repair compared with sutured repair. The present study confirmed this for the first time in nationwide analysis with a long-term follow-up of 5 years up. From earlier studies from our group (Ann Surg 2012) it is known that reoperation rate for recurrence severely underestimates overall (clinical) risk of recurrence making differences between mesh vs. sutured repair even much bigger. Although rare (5%) the incidence of mesh-related complications was progressively increasing throughout the study period suggesting that mesh-related complications rate may continue to accrue with even longer follow-up.

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Despite Variety of Products and Techniques, Surgeons Still Searching For Ideal Mesh For Hernia Repair

MedicalResearch.com Interview with:

Stephen Ferzoco, MD, FACS Chief of General Surgery Atrius Health in Boston

Dr. Stephen Ferzoco

Stephen Ferzoco, MD, FACS
Chief of General Surgery
Atrius Health in Boston

MedicalResearch.com Editor’s Note:  Dr. Stephen Ferzoco, a prominent active, academic surgeon, discusses the complexities of surgery for hernia repair.

MedicalResearch.com: What is the background for this surgery? How many patients are affected by clinically significant hernias?

Response: A hernia is a common condition where soft tissue breaches a weak spot in the abdominal wall. Hernias can affect the abdomen (ventral) or the groin (inguinal). In the U.S. there are about 350,000 ventral hernia procedures each year; these hernia patients present a range of complexity to the surgeon, with some of these procedures being among the most difficult cases for surgeons to manage. Inguinal hernias are even more common, with about 750,000 total procedures performed in the U.S. each year.

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Mesh Hernia Repairs Associated with Fewer Recurrences

MedicalResearch.com Interview with:
Mike K.Liang, MD,
Department of Surgery,
The University of Texas Health
Sciences Center, Lyndon B. Johnson Hospital,Houston, TX 7702

MedicalResearch.com: What are the main findings of the study?

Dr. Liang: Compared to suture repair, mesh repair of primary ventral hernias (umbilical, epigastric, spigelian, lumbar), the most common type of ventral hernias, is associated with fewer hernia recurrence but slightly more seromas and surgical site infections.
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