Laparoscopic ventral hernia repair: local experience
|
|
|
- Antonia Chase
- 10 years ago
- Views:
Transcription
1 O r i g i n a l A r t i c l e Singapore Med J 2004 Vol 45(6) : 271 Laparoscopic ventral hernia repair: local experience K Kannan, C Ng, T Ravintharan Department of General Surgery Changi General Hospital 2 Simei Street 3 Singapore K Kannan, MBBS Medical Officer C Ng, MBBCh, FRCS Associate Consultant T Ravintharan, MBBS, FICS, FRCS Senior Consultant Correspondence to: Dr Ravintharan Tharmalingam 3 Mt Elizabeth #14-15 Mt Elizabeth Medical Centre Singapore Tel: (65) Fax: (65) ravit@ starhub.net.sg or drkannansg@ yahoo.com.sg ABSTRACT Introduction: Laparoscopic ventral hernia repair (LVHR) is a recent development that has been shown to be an effective way of treating ventral hernias. We present the first local series of LVHR with a review of the literature on laparoscopic ventral herniorrhaphy. Methods: We retrospectively reviewed all our patients who underwent laparoscopic surgery for ventral hernias from December 1998 to May Results of LVHR such as operative time, length of hospital stay, complications and recurrence rates were evaluated. Results: Twenty patients underwent LVHR. There were 16 female and four male patients. The average age was 54 years. The mean fascial defect was 46 square cm. An eptfe Mesh was used in all the patients except for one patient who had a prolene mesh. The mean operative time was 117 minutes and the hospital stay was two days. There were two minor complications and no major complications. With a mean follow-up period of 14.9 months, the recurrence rate was 5.0 percent with a single recurrence at four months. Conclusion: Our initial experience with this modality shows that LVHR a feasible option with great potential in both treatment success and reduction of surgical morbidity. Keywords: herniorrhaphy, laparoscopic surgery, laparoscopic ventral hernia repair, ventral hernia Singapore Med J 2004 Vol 45(6): INTRODUCTION The goals of a new technique for ventral hernia repair should be to decrease the high recurrence rates and the associated problems of conventional open hernia repair. The recurrence rates after open ventral herniorrhaphy range from 25% to 52% (1). The use of prosthetic material in open ventral herniorrhaphy has decreased this recurrence rate but with it comes complication of the mesh such as infection (2,3). There have been several well-received series that have reported comparatively lower infection and recurrence rates in the laparoscopic approach to ventral hernia repair (4-6). In this study, we share our initial experience with laparoscopic ventral hernia repair. METHODS There were a total of 20 patients who underwent LVHR between the period of December 1998 to May These were performed by two general surgeons who have a special interest in laparoscopic hernia repair. All patients with ventral wall, incisional and recurrent hernias were selected for LVHR. Patients who had inguinal hernias, obstructed or strangulated hernias, and those with intra-abdominal sepsis were excluded from the laparoscopic repair. The patient s age, sex, hernia type and co-existing medical problems were noted. The hernia defect size, prosthetic material used in the repair, and method of fixation of the prosthesis were recorded. The above data together with length of postoperative stay, peri-operative and post-operative complications were all recorded in a database and analysed. Both surgeons employed a similar operative technique in the study. The angled (30 degrees) 10mm laparoscope was used in all cases. Pre-operative prophylactic antibiotics were given in all cases. All patients were catheterised to decompress the urinary bladder. Gastric decompression was achieved by placement of a naso-gastric tube. The patients were given general anaesthesia and placed in a supine position. Access to the abdomen was accomplished by means of either the open technique or guided entry with a visiport. Adhesiolysis was done using only sharp dissection with minimal use of diathermy. This was to avoid inadvertent thermal injury to the bowel. The hernia contents were reduced but the peritoneal sac was left in-situ. The margins of the hernia defect were delineated and measured. Expanded polytetrafluoro-ethylene (eptfe) mesh (Gore-Tex Dual Mesh Biomaterial, WL Gore, Flagstaff, Arizona, USA) was used. The eptfe Mesh was tailored
2 Singapore Med J 2004 Vol 45(6) : 272 Table I. Hernia characteristics in patients who underwent LVHR. Incisional hernia 12 Paraumbilical hernia 12 Recurrent hernia 2 Previous open repair 2 Single abdominal wall defect 13 Multiple abdominal wall defects 7 2 defects 4 3 defects 3 Mean hernia size (cm 2 ) 46 (2-252) *Contents of hernia sac Nil 6 Omentum 13 Bowel 2 Number of patients with incarcerated hernias 3 *One patient had omentum and bowel within the hernia sac. such that it would overlap the defect by 3cm to 4cm on all sides. Non-absorbable Gore-Tex sutures were placed at the upper and lower ends of the eptfe mesh to achieve secure attachment to the anterior abdominal wall. The mesh was then introduced into the abdominal cavity via the 10mm port. A larger port was used for the very large mesh. After the mesh was positioned intra-peritoneally, the sutures were passed through the anterior abdominal wall using a laparoscopic suture passer (Gore Suture Passer Instrument, WL Gore, Flagstaff, Arizona, USA). The sutures were tied down and secured at two points. The circumference of the mesh was then tacked to the posterior fascia at intervals of 1cm. Drains were not inserted. The wound was infiltrated with a longacting local anaesthetic agent post-operatively in all patients. RESULTS The 20 patients in our data analysis were 16 women and four men, with a mean age of 54 (range 35-78) years. There were nine Indian, four Malay, three Chinese and four Caucasian patients. In our series, hypertension, diabetes, asthma and hypothyroidism were the most common co-existing medical conditions. They bore no co-relation to the presence of hernia in these group of patients. Of the hernia types, there were 12 incisional and 12 paraumbilical hernias in our 20 patients (Table I). About 65% (n=13) of the patients had a single abdominal wall defect, and the rest had multiple defects. There were three incarcerated hernias, all of which were successfully reduced after establishment of pneumoperitoneum. All the patients in the series were operated on as elective cases, with successful completion of the procedure laparoscopically in all cases. No additional Table II. Reported small and large series on LVHR (in chronological order). Length of Mean period Complication hospital stay of follow up Recurrence Year of study No. of patients rate (%) (days) (months) rate (%) Saiz et al (30) < Costanza et al (5) Park et al (19) Toy et al (18) Franklin et al (31) Ramshaw et al (10) Sanders et al (32) Koehler and Voeller (33) Kyzer et al (34) Heniford and Ramshaw (4) Heniford et al (6) Nguyen et al (35) < Chowbey et al (36) LeBlanc et al (18) Moreno-Egea et al (37) Current series
3 Singapore Med J 2004 Vol 45(6) : 273 procedures were carried out during the herniorrhaphy. Intraoperative blood loss was negligible. The mean operative time was 117 minutes (range minutes). The mean size of the eptfe mesh was 206 cm 2 (range cm 2 ). The mean post-operative length of stay was 4.0 days (range 1-10 days). In our series, the overall complication rate was 10.0%. There were no major complications. Four patients had seromas that lasted less than six weeks, one patient had prolonged suture site pain lasting more than eight weeks, and one patient had a flank haematoma. The seromas were not aspirated and allowed to resolve spontaneously. During a mean follow-up period of 14.9 months (range 3 to 45 months), there was a single recurrence at four months, giving a recurrence rate of 5.0%. This patient initially had a laparoscopic repair, following which she experienced prolonged suture site pain especially on standing. Computed tomography showed that the mesh had been partially pulled out of the peritoneal space into the hernia defect by the large abdominal apron of fat due to traction whenever she stood. She subsequently had the mesh refixed during an open surgery. DISCUSSION An incisional hernia develops in 3% to 13% of patients following a laparotomy, and is the most common long-term complication following abdominal surgery (7). A lasting surgical correction of a ventral hernia thus remains a challenge. Open primary suture repair has led to extremely high recurrence rates. For a fascial defect equal to or more than 4cm in size, the recurrence rate exceeds 40%. For a fascial defect less than 4cm in size, the recurrence rate can be as high as 25% (8). The use of prosthetic mesh came into popularity after it was shown that the long-term failure rate could be reduced to 11% to 21% (8-10). However, the placement of mesh typically required extensive soft tissue dissection, raising of flaps and insertion of drains. This in itself increased the incidence of wound infections and local wound complications (4,11,12). The laparoscopic repair of ventral hernia utilises the principles of the open technique popularised by Stoppa, Rives et al, and Wantz (9,13,14). These principles include using a large mesh prosthesis, adequate overlap of the hernia defect, and eliminating tension. In the laparoscopic technique, the mesh is placed intraperitoneally and extensive soft tissue dissection is eliminated. It has been shown, based on widelyquoted comparative studies, that with LVHR wound complication rate, patient discomfort, length of hospital stay, time to return to normal activities and recurrence rates are all reduced (10,15,16). LVHR has also been established as a cost-effective procedure, with total facility costs for the laparoscopic repair being significantly lower than that for the open repair (17). Intra-abdominal placement of a large mesh with wide overlap of defects, use of smaller incisions, laparoscopic adhesiolysis to uncover small unpalpable defects that may go unnoticed with open repair, and use of large non-absorbable sutures for stronger patch fixation could account for the greater success of the laparoscopic operation (5). In our series, the patients as a group had a good outcome. Despite an early experience with this technique, there were no conversions to open surgery. The mean operative time was about 117 minutes, with a single case taking about 260 minutes due to dense intra-abdominal adhesions. This time is longer than most mean operative times reported in other series, which range from 82 to 97 minutes (5,7,10,18). This is attributable to the more careful and meticulous approach adopted by the surgeons in the execution of a new procedure. There were also no operative mortalities or major complications in our series. Seroma formation was the most common post-operative complication, which was defined as any bulge at the operation site observed by the surgeon or the patient. It is considered significant if it lasts more than six weeks. We found that all of them resolved without treatment within six weeks. Heniford et al recommend aspirating seromas in patients who are symptomatic, and allowing the others to resolve spontaneously (6). We also observed that seroma at the site of hernia repair and suture site pain were the most common minor complications reported in other series as well (7,15,19). The suture site pain experienced may have originated from tissue or nerve entrapment during placement of sutures or tacks through the full thickness of the anterior abdominal wall. It could also have resulted from traction of the transabdominal sutures fixing the mesh to the anterior abdominal wall. However, suture placement is vital to the long-term durability of the mesh repair and we do not advocate any change in the technique. Suture site pain can be managed conservatively but the possibility of traction on the mesh from a large, heavy abdominal apron of fat and subsequent detachment must be borne in mind, as was the case in one of our patients. The major complications following LVHR are well documented. These include enterotomy, mesh infection, skin breakdown, intra-abdominal abscess and mortality. The overall complication rates range from 0% to 24% (Table II). The recurrence rate in our series was 5.0%, with a single recurrence at four
4 Singapore Med J 2004 Vol 45(6) : 274 months. Given that 66% to 90% of recurrences occur within two years after operation, our mean follow-up of about 15 months is acceptable, and we do not expect the recurrence rate in this series to change markedly (8,20). Recurrence rates following laparoscopic repair in other series range from 0% to 11% (Table II). 95% of the hernias in our series were repaired with eptfe mesh, with one repair utilising prolene mesh placed in a preperitoneal position for a small hernia early on in our series. Both polypropylene and polyester mesh have been observed to cause severe bowel adhesions, with subsequent intestinal erosion and fistulisation (4,19-25). eptfe also appears to be less easily infected than other biomaterials (26). It is therefore recommended that mesh materials be separated from the intestine, whenever possible (15,20,27). For this purpose, we found the Gore-Tex Dual Mesh to be well suited. The smooth side placed directly adjacent to the bowel has a pore size of 3µm, resulting in minimal tissue attachment; while the other side has an average size of 22µm, allowing tissue ingrowth and attachment to the anterior abdominal wall. There have been no reported cases in the literature of erosion or fistulation with the use of the Dual Mesh. However, eptfe biomaterial costs more and is opaque, making laparoscopic work slightly harder. LVHR can essentially be extended to any patient who is a candidate for open repair and with an acceptable risk for general anaesthesia (28). As experience increases, LVHR can be safely extended to patients with multiple prior abdominal procedures and atypically-located hernias. Incarceration is not a contraindication as onset of anaesthesia, muscle relaxation and introduction of pneumoperitoneum make reduction easy. The procedure should however be generally avoided in children. The data derived from our first 20 patients represents the first local series on laparoscopic ventral hernia repair in Singapore. In our series, we have found this procedure to be technically feasible, safe and effective, with good clinical outcome for our patients. The possible limitations in our series are the relatively small study group and the short mean follow-up period. The concept of LVHR has developed considerably since it was first described by LeBlanc in 1993 (29). This paper serves to share our experience and it is hoped that by doing so, there will be better awareness and acceptability of the procedure. ACKNOWLEDGEMENT We would like to thank Professor R Nambiar, Visiting Senior Consultant in General Surgery, Changi General Hospital, for his invaluable comments and suggestions. REFERENCES 1. Paul A, Korenkov M, Peters S, Kohler L, Fischer S, Troid H. Unacceptable results of the Mayo procedure for repair of abdominal incisional hernias. Eur J Surg 1998; 164: Temudom T, Siadati M, Sarr MG. Repair of complex giant or recurrent ventral hernias by using tension-free intrapariteal prosthetic mesh (Stoppa technique): lessons learned from our initial experience (fifty patients). Surgery 1996; 120: Leber GE, Garb JL, Alexander AL, Reed WD. Long term complications associated with prosthetic repair of incisional hernias. Arch Surg 1998; 133: Heniford BT, Ramshaw BJ. Laparoscopic ventral hernia repair: a report of 100 consecutive cases. Surg Endosc 2000; 14: Costanza MJ, Heniford BT, Arca MJ, Mayes JT, Gagner M. Laparoscopic repair of recurrent ventral hernias. Am Surg 1998; 64: Heniford BT, Park AE, Ramshaw BJ, Voeller G. Laparoscopic ventral and incisional hernia repair in 407 patients. J Am Coll Surg 2000; 190: Mudge M, Huges LE. Incisional hernia: a 10-year prospective study of incidence and attitudes. Br J Surg 1985; 72: Hesselink VJ, Luijendijk RW, de Wilt JH, Heide R, Jeekel J. An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 1993; 176: Stoppa RE. The treatment of complicated groin and incisional hernias. World J Surg 1989; 13: Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncun TD, et al. Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg 1999; 65: White TJ, Santos MC, Thompson JS. Factors affecting wound complications in repair of ventral hernias. Am Surg 1998; 64: Schumpelick V, Conze J, Klinge U. Preperitoneal mesh repair of incisional hernias: A comparative retrospective study. Chirurgie 1996; 67: Rives J, Pire JC, Flament JB, Palot JP, Body C. Treatment of large eventrations. New therapeutic indications apropos of 322 cases. Chirurgie 1985; 111: Wantz GE. Incisional hernioplasty with Mersilene. Surg Gynecol Obstet 1991; 172: Park AE, Birch DW, Lovrics P. Laparoscopic and open incisional hernia repair: a comparison study. Surgery 1998; 124: Holzman MD, Purut CM, Reintgen K, Eubanks S, Pappas TN. Laparoscopic ventral and incisional hernioplasty. Surg Endosc 1997; 11: DeMaria EJ, Moss JM, Sugerman HJ. Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc 2000; 14: LeBlanc KA, Booth WV, Whitaker JM, Bellanger DE. Laparoscopic incisional and ventral herniorrhaphy in 100 patients. Am J Surg 2000; 180: Toy FK, Bailey RW, Carey S, Chappuis CW, Gagner M, Josephs LG, et al. Multicenter prospective study of laparoscopic ventral hernioplasty: preliminary results. Surg Endosc 1998; 12: Linden van der FT, Vroonhoven van TJ. Long term results after surgical correction of incisional hernia. Neth J Surg 1988; 40: Amid PK, Shulman AG, Lichtenstein IL.An experimental evaluation of a new composite mesh with selective property of incorporation to the abdominal wall adhering to the intestines. J Biomed Mater Res 1994; 28: George CD, Ellis H. The results of incisional hernia repair in a 12-year review. Ann R Coll Surg Engl 1986; 68: Heniford BT, Iannitti DA, Gagner MG. Laparoscopic inferior and superior lumbar hernia repair. Arch Surg 1997; 132: Law NW. A comparison of polypropylene mesh, expanded polytetrafluoroethylene and polyglycolic acid mesh for the repair of experimental abdominal wall defects. Acta Chir Scand 1990; 156: Law NW, Ellis H. Adhesion formation and peritoneal healing on prosthetic materials. Clinical Mater 1988; 3: Brown GL, Richardson JD, Malangoni MA, Tobin GR, Ackerman D, Polk Jr HC. Comparison of prosthetic materials for abdominal wall reconstruction in the presence of contamination and infection. Ann Surg 1985; 210:
5 Singapore Med J 2004 Vol 45(6) : Soler N, Verhaeghe P, Essomba A. Treatment of postoperative incisional hernias by composite prosthesis (polyester-polyglactin 910). Clinical and experimental study. Ann Chir 1993; 47: LeBlanc KA. Current considerations in laparoscopic incisional and ventral herniorrhaphy. J Soc Laparoendosc Surg 2000; 4: LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc 1993; 3: Saiz AA, Willis IH, Paul DK, Sivina M. Laparoscopic ventral hernia repair: a community experience. Am Surg 1996; 62: Franklin ME, Dorman JP, Class JL, Balli JE, Gonzalez JJ. Laparoscopic ventral and incisional hernia repair. Surg Laparosc Endosc 1998; 8: Sanders LM, Flint LM, Ferrara JJ. Initial experience with laparoscopic repair of incisional hernias. Am J Surg 1999; 177: Koehler RH, Voeller GR. Recurrences in laparoscopic incisional hernia repairs: a personal series and review of the literature. J Soc Laparoendosc Surg 1999; 3: Kyzer S, Alis M, Aloni Y, Charuzi I. Laparoscopic repair of post operation ventral hernia. Early post operation results. Surg Endosc 1999; 13: Nguyen NT, Lee SL, Mayer KL, Furdui GL, Ho HS. Laparoscopic umbilical herniorrhaphy. J Laparoendosc Adv Surg Tech A 2000; 10: Chowbey PK, Sharma A, Khullar R, Mann V, Baijal M, Vashistha A. Laparoscopic ventral hernia repair. J Laparoendosc Adv Surg Tech A 2000; 10: Moreno-Egea A, Liron R, Girela E, Aguayo JL. Laparoscopic repair of ventral and incisional hernias using a new composite mesh (Parietex): initial experience. Surg Laparosc Endosc Percutan Tech 2001; 11: ST SINGHEALTH SCIENTIFIC MEETING, OCTOBER 2004 SHANGRI-LA HOTEL, SINGAPORE SingHealth is the largest provider of healthcare services in Singapore, with a proud stable of 3 hospitals Changi General Hospital, KK Women s and Children s Hospital and Singapore General Hospital; 5 National Specialist Centres National Cancer Centre Singapore, National Dental Centre, National Heart Centre, National Neuroscience Institute and the Singapore National Eye Centre plus a primary healthcare provider group in SingHealth Polyclinics. Each has diligently built up a strong tradition of Medical Conferences through the years, and it is fitting that we now unleash the synergistic potential of each of these individual Meetings into a combined meeting that will allow greater cross-sharing of new treatment modalities, clinical practice and service quality. At this inaugural combined meeting, we hope to be able to harness the richness and diversity of our medical talent, and this is reflected in our theme: Medicine and Quality from Science to Practise. The Meeting will include sharing of Basic Science, Service Quality and Clinical Practise, including principles of evidence-based medicine. Highlights of the Meeting include a keynote address by our strategic partner, Stanford University, and a sharing of Patient Safety efforts and learnings. The committee is working hard to ensure a vibrant and robust programme over this special weekend. It will offer a combination of plenary lectures and symposia. This synergistic effort is open to all medical practitioners in Singapore and the region, as SingHealth forwards a collaborative stance in continuing to develop leading edge healthcare for Singaporeans, and beyond. For more information, please contact Ms Jocelyn Fan at SGH PGMI on [email protected]
Laparoscopic Repair of Incisional Hernia. Maria B. ALBUJA-CRUZ, MD University of Colorado Department of Surgery-Grand Rounds
Laparoscopic Repair of Incisional Hernia Maria B. ALBUJA-CRUZ, MD University of Colorado Department of Surgery-Grand Rounds Overview Definition Advantages of Laparoscopic Repair Disadvantages of Open Repair
GIANT HERNIA REPAIR MY EXPERIENCE
GIANT HERNIA REPAIR MY EXPERIENCE Giorgobiani G. Department of Surgery at Tbilisi State Medical University. The AVERSI Clinic.Tbilisi, Georgia. If we could artificially produce tissue of the density and
Laparoscopic Hernia Repair. Hernia Repair. Laparoscopic Ventral. Several Different Types of Hernia
Laparoscopic Hernia Repair David B Renton, MD Assistant Professor Department of Surgery The Ohio State University Advantages of Laparoscopic Ventral vs. Open Hernia Repair Lower wound infection rate: 2.6%
Laparoscopic Repair of Parastomal Hernias with a Modified Sugarbaker Technique
Acta chir belg, 2007, 107, 476-480 Laparoscopic Repair of Parastomal Hernias with a Modified Sugarbaker Technique F. Muysoms Department of Surgery, AZ Maria Middelares, Gent, Belgium. Key words. Laparoscopy
PARIETEX MESH CLINICAL STUDIES COMPENDIUM
PARIETEX MESH CLINICAL STUDIES COMPENDIUM CLINICAL ARTICLES REVIEWED New Developments in Hernia Repair 1 Comparison of Tissue Integration Between Polyester and Polypropylene Prostheses in the Preperitoneal
Open Ventral Hernia Repair
Ventral Hernias Open Ventral Hernia Repair UCSF Postgraduate Course in General Surgery Maui, HI March 21, 2011 Hobart W. Harris, MD, MPH Ventral Hernias: National Experience Occur following 11-23% of laparotomies,
Biodesign. Ventral Hernia Repair Best Outcomes. Procedural Guide
Biodesign Ventral Hernia Repair Best Outcomes Procedural Guide Achieve best outcomes using Biodesign for ventral hernia repair. Achieving complete and permanent closure of the abdomen following ventral
ASERNIP-S REPORT NO. 41. July 2004. Australian Safety & Efficacy Register of New Interventional Procedures Surgical
ASERNIP S Australian Safety and Efficacy Register of New Interventional Procedures-Surgical Laparoscopic Ventral Hernia Repair ASERNIP-S REPORT NO. 41 July 2004 Australian Safety & Efficacy Register of
Clinical Study Laparoscopic Umbilical Hernia Repair: Technique Paper
International Scholarly Research Network ISRN Minimally Invasive Surgery Volume 2012, Article ID 906405, 4 pages doi:10.5402/2012/906405 Clinical Study Laparoscopic Umbilical Hernia Repair: Technique Paper
Incisional Hernia Repair by Preperitoneal (Sublay) Mesh Implantation
Original Article Incisional Hernia Repair by Preperitoneal (Sublay) Mesh Implantation Fakhar Hameed, Bashir Ahmed, Asrar Ahmed, Riaz Hussain Dab, Dilawaiz ABSTRACT Incisional Hernia is a common surgical
Are mesh anchoring sutures necessary in ventral hernioplasty? Multicenter study
(2007) DOI 10.1007/s10029-007-0260-1 ORIGINAL ARTICLE Are mesh anchoring sutures necessary in ventral hernioplasty? Multicenter study P. Witkowski F. Abbonante I. Fedorov Z. Jledzijski V. Pejcic L. Slavin
OPEN TENSION FREE REPAIR OF INGUINAL HERNIAS; THE LICHTENSTEIN TECHNIQUE
C:\251 GNA\preperitoneal hernia repair\lichtenstein-english.doc To be considered for publication in BMC-Surgery OPEN TENSION FREE REPAIR OF INGUINAL HERNIAS; THE LICHTENSTEIN TECHNIQUE George H. Sakorafas,
Sandwich technique of closure of lumbar hernia: A novel technique
CASE SERIES 243 OPEN ACCESS Sandwich technique of closure of lumbar hernia: A novel technique Manash Ranjan Sahoo, Anil Kumar T ABSTRACT Background: Lumbar hernia is a rare hernia which accounts for less
Laparoscopic Repair of Hernias. A simple guide to help answer your questions
Laparoscopic Repair of Hernias A simple guide to help answer your questions What is a hernia? A hernia is defined as a hole or defect in the abdominal (belly) wall. A hernia can either be congenital (a
M O V I N G F R E E LY. HerniaCenter. The Columbia Hernia Center at ColumbiaDoctors Midtown
M O V I N G F R E E LY HerniaCenter The Columbia Hernia Center at ColumbiaDoctors Midtown Director, Dr. Peter L. Geller The Columbia Hernia Center brings together a group of surgeons adept in using the
Conservative Approach for Salvaging Infected Prosthetic Mesh after Hernia Repair
Med. J. Cairo Univ., Vol. 79, No. 2, September: 145-149, 2011 www.medicaljournalofcairouniversity.com Conservative Approach for Salvaging Infected Prosthetic Mesh after Hernia Repair SALAH S. SOLIMAN,
Contents. 1. Milestones in Hernia Surgery 1. 2. Surgical Anatomy of Hernia Sites 5. 3. Incidence, Prevalence of Hernia 32
1. Milestones in Hernia Surgery 1 History of the Procedure 3 2. Surgical Anatomy of Hernia Sites 5 Surgical Anatomy of Hernia Sites 5 External Anatomy of Abdominal Wall The Surface Markings 6 The Fascia
Ventral Hernia Repair
Ventral Hernia Repair Open and Laparoscopic Ventral Hernia Repair Technique Guide Ventrio ST Hernia Patch Ventrio Hernia Patch This Technique Guide contains the opinions of and personal surgical techniques
Comparison of infectious complications with synthetic mesh in ventral hernia repair
The American Journal of Surgery (2013) 205, 182-187 Clinical Science Comparison of infectious complications with synthetic mesh in ventral hernia repair Rodger H. Brown, M.D., Anuradha Subramanian, M.D.,
C A R O L I N A S. Hernia Handbook ( C H A P T E R 2 ) B. Todd Heniford, MD
C A R O L I N A S Hernia Handbook ( C H A P T E R 2 ) B. Todd Heniford, MD C H A P T E R 2 Umbilical Hernias C A R O L I N A S H E R N I A H A N D B O O K 17 Umbilical Hernias W H AT I S A N U M B I L
X-Plain Inguinal Hernia Repair Reference Summary
X-Plain Inguinal Hernia Repair Reference Summary Introduction Hernias are common conditions that affect men and women of all ages. Your doctor may recommend a hernia operation. The decision whether or
INFORMATION FOR PATIENTS CONSIDERING LAPAROSCOPIC INGUINAL HERNIA REPAIR
INFORMATION FOR PATIENTS CONSIDERING A LAPAROSCOPIC INGUINAL HERNIA REPAIR Prepared By Mr Peter Willson Consultant Surgeon Contents 1. Background... 3 2. What is an inguinal Hernia?... 3 3. What are the
Bard * PerFix * Plug. Technique Guide. A Modified Technique with the. Open Inguinal Hernia Repair
A Modified Technique with the Bard * PerFix * Plug A quick and simple preperitoneal underlay Modified Technique for the repair of groin hernias Technique Guide Open Inguinal Hernia Repair This technique,
Prosthetic mesh used for inguinal and ventral hernia repair: normal appearance and complications in ultrasound and CT
The British Journal of Radiology, 77 (2004), 261 265 DOI: 10.1259/bjr/63333975 E 2004 The British Institute of Radiology Pictorial review Prosthetic mesh used for inguinal and ventral hernia repair: normal
26. Port Site Closure Methods and Hernia Prevention
26. Port Site Closure Methods and Hernia Prevention Chandrakanth Are, M.D. Mark A. Talamini, M.D. Laparoscopic port site hernias have been frequently reported (incidence of 0.02% 5% with an average of
Laparoscopic hernia repair GEORGIOS SAMPALIS GENERAL SURGEON. Director of surgical department of Lefkos Stavros of Athens
Laparoscopic hernia repair GEORGIOS SAMPALIS GENERAL SURGEON Director of surgical department of Lefkos Stavros of Athens About 600,000 surgical hernia repair procedures are performed every year... Many
ORIGINAL ARTICLE Comparative evaluation of Sublay versus Inlay meshplasty in incisional and ventral hernias
54 ORIGINAL ARTICLE Comparative evaluation of Sublay versus Inlay meshplasty in incisional and ventral hernias Muhammad Ayub Jat, Muhammad Rafique Memon, Ghulam Haider Rind, Syed Qarib Abbas Shah Abstract:
Non-mesh repair of adult inguinal hernia: a simple solution
Original Article Non-mesh repair of adult inguinal hernia: a simple solution ABSTRACT Objective Shaukat Ali Sheikh,* Mohammad Iqbal,** Nauman Mustafa,*** Ihtasham Muhammad Ch.,# Umer Farooq,*** Yasir Mehmood#
ABThera Open Abdomen Negative Pressure Therapy for Active Abdominal Therapy. Case Series
ABThera Open Abdomen Negative Pressure Therapy for Active Abdominal Therapy Case Series Summary of Cases: USER EXPERIENCE The ABThera OA NPT system was found by surgeons to be a convenient and effective
Ventral Hernia Repairs: 10-Year Single-Institution Review at Thomas Jefferson University Hospital
Ventral Hernia Repairs: 10-Year Single-Institution Review at Thomas Jefferson University Hospital Frederick C Sailes, MD, Jason Walls, MD, Daria Guelig, MD, Mike Mirzabeigi, MA, William D Long, MS, Albert
Objectives. Hesselbach s Triangle 5/5/2010. Myopectineal Orifice of Fruchaud. Hernias: Who, What, When, Where, Why?
Objectives Hernias: Who, What, When, Where, Why? J. Scott Roth, MD Chief, Gastrointestinal Surgery Director, Minimally Invasive Surgery University of Kentucky June 16, 2009 Identify patients at risk for
Facing a Hernia Repair? Learn about minimally invasive da Vinci Surgery
Facing a Hernia Repair? Learn about minimally invasive da Vinci Surgery The Condition: Hernia A hernia happens when part of an internal organ or tissue bulges through a hole or weak area in the belly wall
Running head: LAPAROSCOPIC VERSUS OPEN INGUINAL HERNIA REPAIR 1
Running head: LAPAROSCOPIC VERSUS OPEN INGUINAL HERNIA REPAIR 1 Laparoscopic Versus Open Inguinal Hernia Repair Jacob D. Schoeff Advanced Research and Internship Fall, 2010 LAPAROSCOPIC VERSUS OPEN INGUINAL
The TV Series. www.healthybodyhealthymind.com INFORMATION TELEVISION NETWORK
The TV Series www.healthybodyhealthymind.com Produced By: INFORMATION TELEVISION NETWORK ONE PARK PLACE 621 NW 53RD ST BOCA RATON, FL 33428 1-800-INFO-ITV www.itvisus.com 2005 Information Television Network.
ORIGINAL ARTICLE. Giant prosthetic reinforcement of the visceral sac: the Stoppa groin hernia repair in 234 patients
ORIGINAL ARTICLE Giant prosthetic reinforcement of the visceral sac: the Stoppa groin hernia repair in 234 patients Hemmat Maghsoudi, Ali Pourzand BACKGROUND: Recurrent and complex bilateral inguinal hernias
KEYHOLE HERNIA SURGERY
Disclaimer This movie is an educational resource only and should not be used to manage a hernia or abdominal pain. All decisions about the management of a hernia must be made in conjunction with your Physician
Patient. Frequently Asked Questions. Transvaginal Surgical Mesh for Pelvic Organ Prolapse
Patient Frequently Asked Questions Transvaginal Surgical Mesh for Pelvic Organ Prolapse Frequently Asked Questions WHAT IS PELVIC ORGAN PROLAPSE AND HOW IS IT TREATED? Q: What is pelvic organ prolapse
Components Separation Technique for the Repair of Large Abdominal Wall Hernias
Components Separation Technique for the Repair of Large Abdominal Wall Hernias Tammo S de Vries Reilingh, MD, Harry van Goor, MD, PhD, Camiel Rosman, MD, PhD, Marc HA Bemelmans, MD, PhD, Dick de Jong,
INGUINAL HERNIA REPAIR BY DARNING
INGUINAL HERNIA REPAIR BY DARNING BinBisher Saeed A. MD, FICMS Barabba Rabea MD, JBS Diffel and matrix functions INGUINAL HERNIA REPAIR BY DARNING BinBisher Saeed A. MD, FICMS Barabba Rabea MD, JBS INTRODUCTION
Abdominal Wall Hernias
Abdominal Wall Hernias Definition Protrusion of a viscus through an opening in the wall of the cavity in which it is contained The size of a hernia is determined by the dimension of the neck and the volume
Clinical anatomy of the abdominal wall: hernia surgery
Page 1 of 7 Clinical Anatomy Clinical anatomy of the abdominal wall: hernia surgery TG Johnson, SJ Von, WW Hope* Abstract Introduction The surgeon s understanding of the anatomy of the anterior abdominal
Laparoscopic inguinal hernia repair
Abdominal wall M. Miserez, F. Muysoms Leuven, Gent Warm-up Package Eighth edition Strasbourg, April 7, 2011 Laparoscopic inguinal hernia repair Inguinal hernia treatment: factors to consider Recurrence
Sonography of Hernias
Sonography of Hernias Cindy Rapp BS, RDMS, FAIUM, FSDMS Sr. Clinical Marketing Manager Toshiba America Medical Systems Tustin, California What is a hernia? A hernia is a protrusion of an organ or tissue
Vaginal prolapse repair surgery with mesh
Vaginal prolapse repair surgery with mesh Your doctor has recommended a vaginal reconstructive procedure using mesh to treat your condition. The operation involves surgery to reattach the vagina to its
NHS. Surgical repair of vaginal wall prolapse using mesh. National Institute for Health and Clinical Excellence. 1 Guidance.
Issue date: June 2008 NHS National Institute for Health and Clinical Excellence Surgical repair of vaginal wall prolapse using mesh 1 Guidance 1.1 The evidence suggests that surgical repair of vaginal
Mesh Plug Repair of Inguinal Hernias. Presented by: V.K Ashok, M.D, F.A.C.S
Mesh Plug Repair of Inguinal Hernias Presented by: V.K Ashok, M.D, F.A.C.S April 2, 2011 About V.K. Ashok, M.D Practicing general and vascular surgeon in private practice based in Freehold, NJ for the
Get the Facts, Be Informed, Make YOUR Best Decision. Pelvic Organ Prolapse
Pelvic Organ Prolapse ETHICON Women s Health & Urology, a division of ETHICON, INC., a Johnson & Johnson company, is dedicated to providing innovative solutions for common women s health problems and to
Urinary Diversion: Ileovesicostomy/Ileal Loop/Colon Loop
Urinary Diversion: Ileovesicostomy/Ileal Loop/Colon Loop Why do I need this surgery? A urinary diversion is a surgical procedure that is performed to allow urine to safely pass from the kidneys into a
Weight Loss before Hernia Repair Surgery
Weight Loss before Hernia Repair Surgery What is an abdominal wall hernia? The abdomen (commonly called the belly) holds many of your internal organs. In the front, the abdomen is protected by a tough
A retrospective analysis of surgical treatment of mesh infection after repair of ventral hernia or defect
A retrospective analysis of surgical treatment of mesh infection after repair of ventral hernia or defect F.-D. Liu, J.-Y. Li, S. Yao and Y. Zhang Department of General Surgery, General Hospital of Chinese
I.- FLAT MESHES FOR INGUINAL AND VENTRAL HERNIA REPAIR
I.- FLAT MESHES FOR INGUINAL AND VENTRAL HERNIA REPAIR Optilene Mesh B Braun Universal- light mesh for inguinal and incisional hernia repair Optilene Mesh is an universal mesh, which combines a lightweight
False reduction of an inguinal hernia treated by Kugel patch repair via an anterior. 1) Department of Surgery, Asahi General Hospital, Chiba, Japan
Case Report False reduction of an inguinal hernia treated by Kugel patch repair via an anterior approach Naoya Yamada 1, Atsushi Akai 1, Akihiko Seo 1, Yukihiro Nomura 1, Nobutaka Tanaka 1 1) Department
FREEDOM INGUINAL Hernia Repair System TECHNIQUE GUIDE
FREEDOM INGUINAL Hernia Repair System TECHNIQUE GUIDE The following describes the open surgical preparation and implantation technique for the Freedom Inguinal Hernia Repair System. 1) Anesthesia can be
Laparoscopic Inguinal Hernia Repair by Intraperitoneal Onlay Mesh (IPOM) Technique in Specific Cases as an Alternative Method
Journal of Minimally Invasive Surgery Vol. 7. No., 04 pissn 34-778X, eissn 34-548 Original Article http://dx.doi.org/0.760/jmis.04.7..30 Laparoscopic Inguinal Hernia Repair by Intraperitoneal Onlay Mesh
ONSTEP Technique. Technique Guide * Anterior Approach to a Part Preperitoneal, Part Intramuscular Inguinal Hernia Repair
ONSTEP Technique Technical Aspects of the ONSTEP Inguinal Hernia Repair Technique Using the PolySoft Hernia Patch with Interrupted Memory Recoil Ring Technique Guide * Anterior Approach to a Part Preperitoneal,
A comparative study of inguinal hernia repair by Shouldice method vs other methods
Gohel J, Naik N, Parmar H, Solanki B. A comparative study of inguinal hernia by Shouldice method vs other Original Research Article A comparative study of inguinal hernia by Shouldice method vs other methods
Facing a Hysterectomy? If you ve been diagnosed with early stage gynecologic cancer, learn about minimally invasive da Vinci Surgery
Facing a Hysterectomy? If you ve been diagnosed with early stage gynecologic cancer, learn about minimally invasive da Vinci Surgery The Condition: Early Stage Gynecologic Cancer A variety of gynecologic
Evaluation of high-risk, comorbid patients undergoing open ventral hernia repair with synthetic mesh
Evaluation of high-risk, comorbid patients undergoing open ventral hernia repair with synthetic mesh David M. Krpata, MD, Jeffrey A. Blatnik, MD, Yuri W. Novitsky, MD, and Michael J. Rosen, MD, FACS, Cleveland,
Laparoscopic versus open incisional hernia repair: An institutional experience
International Journal of Scientific and Research Publications, Volume 5, Issue 5, May 2015 1 Laparoscopic versus open incisional hernia repair: An institutional experience Dr. Vijay Koduru *, Prof. Annappa
Open Suture Repair and Open Onlay Technique for Incisional Hernia in Elderly Patients with Multiple Comorbidities
Open Suture Repair and Open Onlay Technique for Incisional Hernia in Elderly Patients with Multiple Comorbidities Jung-Sheng Chien MD 1, Pei-Jiun Tsai MD 1, Kuang-Yi Liu MD 3, Shin-E Wang MD 1, Yi-Ming
Guide to Abdominal or Gastroenterological Surgery Claims
What are the steps towards abdominal surgery? Investigation and Diagnosis It is very important that all necessary tests are undertaken to investigate the patient s symptoms appropriately and an accurate
The Abdominal Wall And Hernias. Stanley Kurek, DO, FACS Associate Professor of Surgery UTMCK
The Abdominal Wall And Hernias Stanley Kurek, DO, FACS Associate Professor of Surgery UTMCK The Abdominal Wall The structure of the abdominal wall is similar in principle to the thoracic wall. There are
Tissue Reinforcement Solutions
Tissue Reinforcement Solutions Tissue Reinforcement Solutions Confidence in your hands One source for all your surgical mesh needs. One source for all your surgical mesh needs. Contact your local ETHICON
Mesh Location in Open Ventral Hernia Repair: A Systematic Review and Network Meta-analysis
DOI 10.1007/s00268-015-3252-9 SCIENTIFIC REVIEW Mesh Location in Open Ventral Hernia Repair: A Systematic Review and Network Meta-analysis Julie L. Holihan 1 Duyen H. Nguyen 1 Mylan T. Nguyen 1 Jiandi
Recurrent incisional hernia sublay repair with fully reabsorbable monofilament mesh a case report
science 14 Incisional hernia is a common postoperative complication of abdominal surgery, with the incidence ranging from 11% up to 20% of all laparotomy incisions. Recurrent incisional hernia sublay repair
Inguinal (Groin) Hernia Repair
Information for patients Inguinal (Groin) Hernia Repair General Surgery Tel: 01473 712233 DMI ref: 11582-09.indd(RP) Issue 1: February 2010 The Ipswich Hospital NHS Trust, 2010. All rights reserved. Not
Best Practice Management of Incisional Hernia
Best Practice Management of Incisional Hernia Kevin Sexton Bonus Conference February 2013 1 Disclosure: None for this presentation. 2 Definitions: A gentleman is someone who owns land. -Tarp Incisional
Original Article A LONG TERM FOLLOW UP: MESH VERSUS MAYO S REPAIR IN PARA- UMBILICAL HERNIA.
Original Article VERSUS MAYO S REPAIR IN PARA- UMBILICAL HERNIA. Abdul Qayoom Daudpoto *, Shahid Mirani **, Rafique Ahmed Memon ***, Dr Qarib Abbas **** * Assistant Professor Surgery (Former)Department
Inguinal Hernia (Female)
Inguinal Hernia (Female) WHAT IS AN INGUINAL HERNIA? 2 WHAT CAUSES AN INGUINAL HERNIA? 2 WHAT DOES TREATMENT / MANAGEMENT INVOLVE? 3 DAY SURGERY MANAGEMENT 3 SURGICAL REPAIR 4 WHAT ARE THE RISKS/COMPLICATIONS
Is Laparoscopic Inguinal Hernia Repair an Operation of the Past?
COLLECTIVE REVIEWS Is Laparoscopic Inguinal Hernia Repair an Operation of the Past? Lorelei J Grunwaldt, MD, Steven D Schwaitzberg, MD, FACS, David W Rattner, MD, FACS, Daniel B Jones, MD, FACS There is
Consumer summary Minimally invasive techniques for the relief of stress urinary incontinence
ASERNIP S Australian Safety and Efficacy Register of New Interventional Procedures Surgical Consumer summary Minimally invasive techniques for the relief of stress urinary incontinence (Adapted from the
Femoral Hernia Repair
Femoral Hernia Repair WHAT IS A FEMORAL HERNIA REPAIR? 2 WHAT CAUSES A FEMORAL HERNIA? 2 WHAT DOES TREATMENT/ MANAGEMENT INVOLVE? 3 DAY SURGERY MANAGEMENT 3 SURGICAL REPAIR 4 WHAT ARE THE RISKS/COMPLICATIONS
Healthletter. Hernias They Should not be Ignored. August 2009
Healthletter August 2009 Hernias They Should not be Ignored Did you know that over five million Americans suffer from some type of hernia? For many of these people, this condition causes substantial pain
Synopses of Causation
Ministry of Defence Synopses of Causation Hernia Author: Dr Kimberley Jensen, Medical Author, Medical Text, Edinburgh Validator: Professor G Layer, Royal Surrey County Hospital, Guildford Disclaimer This
ROYAL AUSTRALASIAN COLLEGE OF SURGEONS
ROYAL AUSTRALASIAN COLLEGE OF SURGEONS SUBMISSION TO THE HEALTH SELECT COMMITTEE ON THE PETITION 2011 / 102 CARMEL BERRY AND CHARLOTTE KORTE REGARDING SURGICAL MESH MAY 2015 Introduction The Royal Australasian
Brought to You by. Benefits of GORE DUALMESH Biomaterial in Hernia Repair: A Case-based Presentation. Alfredo M. Carbonell, DO
Brought to You by July 2012 REPORT Benefits of GORE DUALMESH Biomaterial in Hernia Repair: A Case-based Presentation Introduction from the Faculty Chair Karl LeBlanc, MD Baton Rouge, Louisiana Considered
9/26/14. Joel E. Rand, MPAS, PA-C DMU Luncheon May 1, 2014
Joel E. Rand, MPAS, PA-C DMU Luncheon May 1, 2014 No financial relationship or commercial interest in any of the technologies discussed Not supporting any non-fda off label uses of any product or service
Umbilical or Paraumbilical Hernia Adults
Umbilical or Paraumbilical Hernia Adults WHAT IS AN UMBILICAL OR PARAUMBILICAL HERNIA? 2 THE OPERATION? 2 ANY ALTERNATIVES 3 BEFORE THE OPERATION 3 AFTER YOUR SURGERY - IN HOSPITAL 4 POSSIBLE COMPLICATIONS?
Procedure Name: Day Case - Laparoscopic Inguinal Hernia Repair (TEP)
Dr Philip Lockie MB BCh MPhil FRCSI FRACS PO Box 1275, Kenmore 4069 Tel: 07 3834 7080 Fax: 07 3834 6148 E-mail: [email protected] Provider No: 248127EW Brochure Code: DC GS13 Procedure Name: Day
INTERVENTIONAL PROCEDURES PROGRAMME
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of radical laparoscopic hysterectomy for early stage cervical cancer Introduction This overview
Acute Abdominal Pain following Bariatric Surgery. Disclosure. Objectives 8/17/2015. I have nothing to disclose
Acute Abdominal Pain following Bariatric Surgery Kathy J. Morris, DNP, APRN, FNP C, FAANP University of Nebraska Medical Center College of Nursing Disclosure I have nothing to disclose Objectives Pathophysiology
Bladder Injury during Cesarean Section: A Case Control Study for 10 Years
Bahrain Medical Bulletin, Vol., No., September Bladder Injury during Cesarean Section: A Case Control Study for Years Mesfer Al-Shahrani, MD, FRCSC* Objective: To determine the incidence, risk factors
INFORMATION SHEET FOR A LAPAROSCOPIC SLEEVE GASTRECTOMY
INFORMATION SHEET FOR A LAPAROSCOPIC SLEEVE GASTRECTOMY You are considering undergoing a laparoscopic sleeve gastrectomy for weight loss. The purpose of this information sheet is to provide you with the
Informed Consent for Laparoscopic Vertical Sleeve Gastrectomy. Patient Name
Informed Consent for Laparoscopic Vertical Sleeve Gastrectomy Patient Name Please read this form carefully and ask about anything you may not understand. I consent to have a laparoscopic Vertical Sleeve
Emergencies in Post- Bariatric Surgery Patients
Emergencies in Post- Patients Disclosures Dr. Birnbaumer has no financial disclosures Diane M. Birnbaumer, M.D., FACEP Professor of Medicine University of California, Los Angeles Senior Clinical Educator
Dept. of Medical Imaging University of Ottawa
ED Visits Related to Bariatric Surgery: Review of Normal Post-Surgical Anatomy as Well as Complications Dept. of Medical Imaging University of Ottawa Disclosures Background Roux-en-Y Gastric Bypass Surgery
The main surgical options for treating early stage cervical cancer are:
INFORMATION LEAFLET ON TOTAL LAPAROSCOPIC RADICAL HYSTERECTOMY (TLRH) FOR EARLY STAGE CERVICAL CANCER (TREATING EARLY STAGE CERVICAL CANCER BY RADICAL HYSTERECTOMY THROUGH KEYHOLE SURGERY) Aim of the leaflet
FEMALE UROLOGY Suprapubic sling adjustment: minimally invasive method of curing recurrent stress incontinence after sling surgery
FEMALE UROLOGY Suprapubic sling adjustment: minimally invasive method of curing recurrent stress incontinence after sling surgery Choe JM Urodynamics and Continence Center, Division of Urology, University
OVER 45 YEARS TEXTILE GRAFT TECHNOLOGY EXPERIENCE MAQUET THE GOLD STANDARD
OVER 45 YEARS TEXTILE GRAFT TECHNOLOGY EXPERIENCE MAQUET THE GOLD STANDARD A comprehensive, proven vascular graft portfolio and exceptional professional support make MAQUET Cardiovascular a valuable asset
SILS. Port Insertion By Homero Rivas, MD, MBA, FACS. Single incision. Single port. Simple choice.
SILS Port Insertion By Homero Rivas, MD, MBA, FACS Single incision. Single port. Simple choice. SILS Port Insertion By Homero Rivas, MD, MBA, FACS For the last 20 years, there has given surgical procedure.
Women s Health. The TVT procedure. Information for patients
Women s Health The TVT procedure Information for patients What is a TVT procedure? A TVT (Tension-free Vaginal Tape) procedure is an operation to help women with stress incontinence the leakage of urine
Hernia Repair Devices Market in US 2015-2019
Brochure More information from http://www.researchandmarkets.com/reports/3280780/ Hernia Repair Devices Market in US 2015-2019 Description: About Hernia Repair Devices Hernia is the protrusion of a tissue,
ATHLETIC PUBALGIA SURGERY
ATHLETIC PUBALGIA SURGERY MEDICAL POLICY Policy Number: 20T03H Effective Date: July, 20 Table of Contents COVERAGE RATIONALE... BACKGROUND... CLINICAL EVIDENCE... U.S. FOOD AND DRUG ADMINISTRATION... CENTERS
