Author Interviews, Surgical Research / 24.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44751" align="alignleft" width="140"]Maarten Persenaire, MD Co-founder, Chief Medical Officer TELA Bio Dr. Persenaire[/caption] 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. 
Author Interviews, Surgical Research / 02.04.2018

MedicalResearch.com Interview with: [caption id="attachment_40921" align="alignleft" width="200"]Michael Sawyer, MD, FACS General Surgeon Comanche County Memorial Hospital Lawton, Oklahoma Dr. Michael Sawyer[/caption] 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.
Author Interviews, Lancet, OBGYNE, Surgical Research / 22.12.2016

MedicalResearch.com Interview with: Dr Rachael Wood PhD Consultant in Public Health Medicine - women and children's health NHS National Services Scotland Information Services Division Edinburgh MedicalResearch.com: What is the background for this study? Response: Mesh surgery for female stress urinary incontinence and pelvic organ prolapse is currently controversial. Mesh surgery was introduced to overcome recognised limitations of traditional, non-mesh, surgery for these conditions, in particular extensive surgery and long hospital stays for incontinence and high failure/recurrence rates for prolapse. Mesh surgery may therefore offer additional benefits over traditional surgery. Mesh surgery may also carry additional risks however, with patient advocacy groups highlighting cases of severe, long term, mesh-related complications in some women who have undergone mesh surgery. We therefore used routinely available, population based hospital discharge records from Scotland to identify women having mesh and non-mesh procedures for incontinence and prolapse. We then followed the women up for up to 5 years to assess how often they were readmitted for complications or further incontinence or prolapse surgery.
Author Interviews, Gender Differences, Lancet, OBGYNE, Surgical Research / 21.12.2016

MedicalResearch.com Interview with: [caption id="attachment_30694" align="alignleft" width="140"]Prof. Cathryn Glazener PhD Health Services Research Unit University of Aberdeen Aberdeen,UK Prof. Cathryn Glazener[/caption] Prof. Cathryn Glazener PhD Health Services Research Unit University of Aberdeen Aberdeen,UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prolapse is a condition that affects up to half of all women after childbirth. Women notice a bulge or discomfort in their vaginas due to pressure from the bladder, bowel or womb moving downwards. Women who have surgery for their prolapse have a 3 in 10 chance of needing at least one more operation, so the success rate is not great. Gynaecologists hoped that by reinforcing their repairs the success rate would get better. PROSPECT was a pragmatic, multicentre randomised controlled trial conducted in 35 centres across the UK. Women undergoing their first operation for prolapse were randomised to having a standard repair of the front or back wall of the vagina, or a repair reinforced by synthetic non-absorbable mesh, or a biological graft. We found that, in contrast to previous research, women were just as likely to be cured after standard surgery rather than reinforced repairs. They were just as likely to have other symptoms such as bladder or sexual problems, and other adverse effects such as infection, bleeding or pain. However, about 1 in 10 of the women who had mesh did have mesh exposure when a small portion of the mesh becomes visible through the vaginal wall. Although many women did not have symptoms, about half of those women needed a small operation to remove or bury the exposed mesh.
Author Interviews, JAMA, Surgical Research / 21.10.2016

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.
Author Interviews, BMJ, Urology / 09.06.2015

MedicalResearch.com Interview with: Bilal Chughtai, MD & Art Sedrakyan, MD, PhD Department of Urology Weill Cornell Medical College Medical Research: What is the background for this study? What are the main findings? Response: Since 2008, the U.S. Food and Drug Administration has released number of public health notifications cautioning the use of mesh in pelvic organ prolapse (POP) surgery. Despite these notifications and subsequent public scrutiny, studies have reported a large increase of mesh use in female patients with pelvic organ prolapse during the last decade. In light of the reported rise in mesh utilization, we sought to determine the use of mesh in prolapse surgery and compare short-term outcomes of prolapse surgery with or without mesh. After identifying 7,338 and 20,653 patients who underwent prolapse repair procedures with and without mesh in a 4-year period, we found that mesh use increased 44.7%. Most patients were under 65 (62.3%), and there were more patients older than 65 years in the mesh group (44.3% versus 35.4%). Overall, complications were not common. However, patients who received mesh were more likely to experience urinary retention within 90-days and had a higher chance of having re-intervention at 1 year. Mesh use was also associated with higher risk of urinary retention in older patients (≥ 65 year olds) and re-intervention within 1 year in younger patients (<65 year olds).
Author Interviews, Gastrointestinal Disease, General Medicine, Surgical Research / 13.09.2014

Dr. Dee Fenner, M.D. Professor of Obstetrics and Gynecology Director of Gynecology University of MichiganMedicalResearch.com Interview with: Dr. Dee Fenner, M.D. Professor of Obstetrics and Gynecology Director of Gynecology University of Michigan MedicalResearch.com Editor’s note: American Medical Systems Inc. (AMS), a subsidiary of Endo International plc (Nasdaq: ENDP) (TSX: ENL), released top-line results from its TRANSFORM study that show the investigational TOPAS™ System improves fecal incontinence in women. The results show that over a 12 month period, 69% of women suffering from fecal incontinence who were implanted with the TOPAS™ System experienced at least a 50% reduction in weekly incontinence episodes and experienced a durable, consistent effect across the study period. The results were presented in Cape Town, South Africa at the International Society of University Colon & Rectal Surgeon (ISUCRS) Congress. Dr. Fenner, a primary investigator of the study, kindly answered the questions below: Medical Research: How common/prevalent is the problem of fecal incontinence in women? Dr. Fenner: Fecal incontinence, also known as accidental bowel leakage (ABL), is estimated to affect nearly 11 million women and 10% of women over the age of 20 in the United States.1,2 Additionally, nearly one in five women over the age of 45 experience ABL at least once a year.3
Mayo Clinic, Urology / 20.05.2014

Daniel S. Elliott, M.D MAYO Clinic, Associate Professor Department of Urology Section of Pelvic and Reconstructive Surgery Rochester, MinnesotaMedicalResearch.com Interview with: Daniel S. Elliott, M.D MAYO Clinic, Associate Professor Department of Urology Section of Pelvic and Reconstructive Surgery Rochester, Minnesota MedicalResearch: What are the main findings of the study?  Dr. Elliott: The biggest issue is that we were able to devise a new procedure that is a simple outpatient anti-incontinence surgery for women that does NOT use any synthetic meshes.  The importance of this is that all traditional (meaning NON-mesh) surgeries for female incontinence have been large surgeries with fairly significant risks such as pain, bleeding and prolonged recovery.  When the meshes came out in the late ‘90’s, their big benefit was that they were outpatient and quick procedures.  But now that we are discovering all the long term complications from meshes such as chronic pain, scarring, painful intercourse, vaginal extrusion of the meshes, and organ injury, patients have become VERY reluctant and fearful to undergo any mesh type surgery.    Therefore, we devised a new procedure that used a very small piece of the patient’s own tissue (from the rectus fascia) and placed this via the “transobturator route.”  In the process, we melded together the “best” of both worlds---a NON-mesh, outpatient anti-incontinence procedure that is safe (no long term problems as seen with meshes) .