FULL DAY: How Do You Measure Up? ASSESS Your Skills
PROGRAM CHAIR Ernest G. Lockrow, DO
Angela Chaudhari, MD Grace Chen, MD Susan G. Dunlow, MD Joseph M. Gobern, MD, MBA Candice Jones-Cox, MD Leslie D. Kammire, MD Malcolm W. Mackenzie, MD Douglas Miyazaki, MD Jamal Mourad, DO Brent E. Seibel, MD Sangeeta Senapati, MD M. Jonathon Solnik, MD Sabrina Whitehurst, MD
AAGL acknowledges that it has received support in part by educational grants and equipment (in-kind) from the following companies: 3-Dmed, Applied Medical, Boston Scientific, CooperSurgical, Ethicon US, LLC, Marina Medical, Medtronic, Olympus America, Inc., Karl Storz Endoscopy-America, Inc., Symmetry Surgical
Sponsored by
Advancing MinimallyAAGL Invasive Gynecology Worldwide
Professional Education Information
Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology.
Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The AAGL designates this live activity for a maximum of 7.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.
Table of Contents
Course Description ...... 1
Disclosure ...... 2
Laparoscopic Hysterectomy S. Senapati ...... 3
Complications of Laparoscopy E.G. Lockrow ...... 12
Vaginal Hysterectomy M.J. Solnik ...... 21
Retropubic Slings D. Miyazaki ...... 28
Cultural and Linguistics Competency ...... 35
SKIL-700 FULL DAY: How Do You Measure Up? ASSESS Your Skills
Presented in affiliation with the American College of Obstetricians and Gynecologists (ACOG)
Ernest G. Lockrow, Chair
Faculty: Angela Chaudhari, Grace Chen, Susan G. Dunlow, Joseph M. Gobern, Candice Jones-Cox, Leslie D. Kammire, Malcolm W. Mackenzie, Douglas Miyazaki, Jamal Mourad, Brent E. Seibel, Sangeeta Senapati, M. Jonathon Solnik, Sabrina Whitehurst
This course was developed in collaboration with the ACOG Simulations Consortium and is specifically designed to assess gynecologic surgeons in all levels of training on various gynecologic surgeries. The modules used from the Advanced Surgical Simulation and Endoscopic Surgical Simulation (ASSESS) Course include: Vaginal Hysterectomy, Laparoscopic Hysterectomy and Retropubic Slings. Whether you are a current expert in the field of gynecologic surgery or have not been able to perform minimally invasive surgical procedures such as vaginal hysterectomy, laparoscopic surgery or retropubic slings, this course will afford you the opportunity to assess your current level of expertise in gynecologic surgery. This is a hands-on course utilizing moderate fidelity simulation models from industry that you will be able to perform an actual vaginal hysterectomy, laparoscopic hysterectomy and retropubic sling. The course is an ABOG Maintenance of Certification (MOC) approved simulation course that will afford the participants credit during their MOC cycle.
Learning Objectives: At the conclusion of this course, the clinicians will be able to: 1) Assess their skills in performing laparoscopic hysterectomy; 2) assess their skills in performing vaginal hysterectomy; and 3) assess their skills in performing retropublic slings.
Course Outline
7:00 Welcome, Introductions and Course Overview E.G. Lockrow 7:15 Laparoscopic Hysterectomy S. Senapati 7:45 Complications of Laparoscopy E.G. Lockrow 8:30 Questions & Answers All Faculty 8:45 Break 9:00 LAB I: Using the Limbs and Things Model: Group A Performs Laparoscopic Hysterectomy, Group B Performs Laparoscopic Suturing Skills 10:50 Questions & Answers 11:00 Adjourn/Lunch 12:30 Vaginal Hysterectomy M.J. Solnik 1:15 Retropubic Slings D. Miyazaki 2:00 Questions & Answers All Faculty 2:15 Break 2:30 LAB II: Using the MIYA Model: Group A Performs Vaginal Hysterectomy, Group B Performs Retropubic Slings 4:15 Wrap-Up 4:30 Adjourn
1 PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Erica Dun* Frank D. Loffer, Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Johnny Yi*
SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: Intuitive Royalty: CooperSurgical Sarah L. Cohen* Jon I. Einarsson* Stuart Hart Consultant: Covidien Speakers Bureau: Boston Scientific, Covidien Kimberly A. Kho Contracted/Research: Applied Medical Other: Pivotal Protocol Advisor: Actamax Matthew T. Siedhoff Other: Payment for Training Sales Representatives: Teleflex M. Jonathon Solnik Consultant: Z Microsystems Other: Faculty for PACE Surgical Courses: Covidien
FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Angela Chaudhari* Grace Chen* Susan G. Dunlow* Joseph M. Gobern* Candice Jones-Cox* Leslie D. Kammire* Ernest G. Lockrow* Malcolm W. Mackenzie Consultant: Olympus Douglas Miyazaki* Jamal Mourad* Brent E. Seibel* Sangeeta Senapati Consultant: Emmi M. Jonathon Solnik Consultant: Z Microsystems Other: Faculty for PACE Surgical Courses: Covidien Sabrina Whitehurst* Asterisk (*) denotes no financial relationships to disclose. 2 Laparoscopic Hysterectomy: A Review of the Basics
• Consultant: Emmi Sangeeta Senapati, MD
Northshore University HealthSystem
Evolution of Hysterectomy • Approximately 600,000 hysterectomies • Explain the rationale for a laparoscopic performed each year in U.S. approach to hysterectomy • $5 Billion • Discuss options for instrumentation and key • By age 60, 1 in 3 women in U.S. will have had a technical components hysterectomy • 90% performed for elective benign indications • Describe a technique for conventional – Fibroids laparoscopic hysterectomy – Abnormal uterine bleeding • Review variations of laparoscopic – Endometriosis hysterectomies – Chronic pelvic pain
Carlson et al N Engl J Med 1993
Epidemiology
• Age range ‐ median 44‐45 yrs1 • Ethnicity ‐ 69% Caucasian, 17% African‐ American, 10.5% Hispanic2 • LOS ‐ median 2‐3 days1 • Complication rates ‐ 1‐3%2 • Transfusion rates ‐ 1‐3%3
1Farquhar CM & Steiner CA Ob Gyn2002; 2Campbell ES et al JRM 2003; 4Meikle SF et al Ob Gyn 19973
3 Evolution of Hysterectomy Laparoscopic Hysterectomy Classification • Total abdominal & vaginal hysterectomy (TAH, TVH) • Laparoscopic‐assisted vaginal hysterectomy, introduced by Reich in late 1980s (LAVH) • Laparoscopic supracervical hysterectomy (LSH) • Total laparoscopic hysterectomy (TLH)
66% of all hysterectomies performed in the U.S. are abdominal
Wu et al, Ob Gyn 2007
Laparoscopic Hysterectomy Criteria Classification • A non‐vaginal hysterectomy candidate who by traditional methods would have undergone hysterectomy abdominally
There are no absolute contraindications, just relative: surgeon experience, anatomical operating field, anesthesia, abdominal entry issues…
Potential Indications Benefits of Laparoscopy vs. Laparotomy (Cochrane Review of Hysterectomy)
• Difficult vaginal access • Faster return to normal activities • Decreased mobility of the uterus • MD -15.17, 95% CI -17.21 to -13.14 • Large uterus • Fewer febrile episodes • Suspicious adhesions from prior surgeries • OR 0.25, 95% CI 0.09 to 0.73 • Fewer wound or abdominal wall infections • Severe endometriosis • OR 0.29, 95% CI 0.12 to 0.71 • Presence of an adnexal mass
4 Benefits in the Obese Patient Instruments • Shorter hospital stay (2.5 vs. 5.6 days) Uterine Manipulator TLH configuration • VCARE • Less post operative pain • RUMI + Koh colpotomy rings (Koh colpotomy ring, ZUMI uterine manipulator, vaginal • Earlier return to normal activity1 • Vaginal balloon pneumo‐ balloon pneumo‐occluder) occluder
• Less post operative ileus (0 vs. 13%) • Fewer postoperative fevers (5.5 vs. 31.1%) • Fewer wound infections (9 vs. 22%)2
1Eltabbakh et al. Gynecol Oncol 2000, 2Enochsson et al. Surg Endosc 2001
Electrosurgical Vessel Sealing Key Concepts Technology Advanced bipolar vessel sealing and cutting devices do not work like cold scissors LigaSure Halo PK “TENSION‐FREE SEALING & TRANSECTION” EnSeal Harmonic Ace Surgical technique otherwise modeled after abdominal hysterectomy
Technical Steps Technical Steps
• Survey of operative field: Create a game plan • Management of vaginal cuff • Adnexal management – Colpotomy • Round ligament & entry into broad ligament – Closure • Vesico‐uterine reflection • Specimen extraction • Skeletonization & ligation of uterine • Post‐operative care/precautions vasculature
5 Patient Positioning Positioning
• Dorsal lithotomy • Obese patients are at a greater risk of pressure sores and neural injuries! • Arms padded and tucked at – Ultrafins: Yellowfins for the obese sides – Shoulder braces or other antiskid measures – Vacuum beanbag • Steep Trendelenburg – Toboggans or arm supports – Neck support • Decompress stomach & bladder
Laparoscopic Access Issues with Obesity • Decreased surgical landmarks for placement of the Veress needle • Direct vs. open (Hasson technique) vs. Veress • Grasp umbilicus with towel hooks needle (standard, long) • Assure that you enter the belly perpendicular to the skin • Use a long Veress 150mm • Consider a left upper quadrant entry at Palmer’s point • Transforniceal • Consider vaginal placement of veress in women with no risk for pelvic adhesive disease • Left upper quadrant (Palmer’s Point)
Left Upper Quadrant Entry Trocar Placement • Key Points – Empty the stomach (OG/NG) A= 5‐10 mm umbilical or supraumbilical for – Placement in the mid clavicular line (or just laparoscope lateral to this) – Using a veress needle: 3 “pops” for entry into B = 5‐15 mm right & left lower the peritoneal cavity quadrant as well as – Opening pressure <10mm Hg suprapubic – Can insufflate up to 20mm Hg for port placement Consider in pregnant patients, those with large abdominal masses, large uteri, or those with prior midline surgery
6 Ports and Port Placement Angled Scope • Long ports (15cm) must be available to use. • Increase pneumoperitoneum to 20mm Hg to aid with safe placement of the trocars. • Adjust for the pannus when trying to place your trocars based on the usual anatomic landmarks. • Think about placing the ports more laterally as this will often give you more exposure and decrease the torque on the ports.
Retraction Techniques Adnexa
Round Ligament Vesicouterine Peritoneum
7 Uterine Vasculature Blanched Uterus
Morcellation Alternatives to Power Morcellation Techniques
• Vaginal morcellation
• Minilaparotomy morcellation
• Enclosed power morcellation in bag
• Extraction through posterior colpotomy
Vaginal Morcellation Minilaparotomy • Bivalving
• Coring
• Wedging • Myomectomy Protection of the edges of the incision Self-retaining retractor Specimen bag
8 Cervical Stump Adhesion Barrier
Colpotomy Cuff Closure
Cystoscopy Post Op Care • Overall urinary tract injury rate 0.73%1 2 – Risk is greater than with abdominal hysterectomy • Hospital discharge either same day or next day – May have delayed injury from thermal damage – Expectations (talk about this ahead of time) • Procedure: 70 degree or 30 degree scope • Lifting restrictions (< 10 lbs) – Water, saline, or 10% dextrose as the distention • Pain management: NSAIDS, narcotics media – Can use IV indigo carmine, IV methylene blue or • 2 week recovery time preoperative oral phenazo‐pyridine for • Pelvic rest! 6‐8 weeks visualization of ureteral jets of urine
Adelman et al JMIG 20141 Aarts et al Cochrane Database Syst Rev. 20152
9 Vaginal Cuff Dehiscence Challenges of Conventional Laparoscopy • Presentation • Limited degree of motion within the body – Bleeding, serous discharge, pain – Cuff separation or bowel evisceration • Hand movement is counter‐intuitive (fulcrum effect) • Dehiscence Rate (<1‐5%) ‐ > 1.35% • View of operative field is on a 2‐D monitor Iaco (%) Hur (%) Kim (%) TAH 0.25 0.38 1.56* • Unsteady image TVH 0.26 0.11 TLH 0.79 0.75 5.42 • Significant learning curve exists for advanced cases * Radical hyst
Iaco et al Eur J Obstet Gynecol Reprod Biol. 2006 Hur et al Obstet Gynecol 2007, Kim et al Obstet Gynecol Sci 2014
Robotic‐Assisted Laparoscopy: Highlights Single Port Surgery • Surgeon controls the robotic arms remotely • 3‐D image through stereoscopic viewer (high definition option) • SPA (single port access) vs. standard multiport • No haptic (tactile) feedback technique • Seven degrees of movement mimic human wrist movement (eliminate fulcrum effect) – Comparable operative times, blood loss, and length • Tremor filtration & motion scaling of stay • Enabling technology (shortening learning curves) – No difference in pain or cosmetic outcomes
Sarle et al. J Endouro 2004
Kim et al JMIG 2015
Summary Limbs and Things • Laparoscopic hysterectomy is preferred over abdominal hysterectomy where vaginal hysterectomy not appropriate • Basic technical steps will be the same despite multiple variations on technique • Know your options regarding instrumentation and suture material • Pre‐operative counseling is important! Manage expectations
10 • Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;8:CD003677 • Adelman MR, Bardsley TR, Sharp HT. Urinary tract injuries in laparoscopic hysterectomy: a systematic review. J Minim Invasive Gynecol. 2014 Jul‐Aug;21(4):558‐66 • Campbell ES, Xiao H, Smith MK. Types of hysterectomy. Comparison of characteristics, hospital costs, utilization and outcomes. J Reprod Med. 2003 Dec;48(12):943‐9. • Carlson KJ, Hichols DH, Schiff I Indications for hysterectomy. N Eng J Med 1993;328:856‐60. • Eltabbakh GH, Shamonki MI, Moody JM, Garafano LL. Hysterectomy for obese women with endometrial cancer: laparoscopy or laparotomy? Gynecol Oncol. 2000 Sep;78(3 Pt 1):329‐35. • Enochsson L, Hellberg A, Rudberg C, et al. Laparoscopic vs open appendectomy in overweight patients. Surg Endosc. 2001 Apr;15(4):387‐92 • Farquhar CM, Steiner CA Hysterectomy rates in the United States 1990‐1997. Obstet Gynecol. 2002 Feb;99(2):229‐34. • Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T. Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011 Oct;118(4):794‐801. • Iaco PD, Ceccaroni M, Alboni C, et al. Transvaginal evisceration after hysterectomy: is vaginal cuff closure associated with a reduced risk? Eur J Obstet Gynecol Reprod Biol. 2006;125:134–138 • Kim M, Kim S, Bae H et al. Evaluation of risk factors of vaginal cuff dehiscence after hysterectomy. Vacc Obstet Gynecol Sci 2014;57(2):136‐143 ,• Kim TJ Shin SJ, Kim TH et al. Multi‐institution, Prospective, Randomized Trial to Compare the Success Rates of Single‐port Versus Multiport Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis. J Minim Invasive Gynecol. 2015 Jul‐Aug;22(5):785‐91. • Meikle SF, Nugent EW, Orleans M. Complications and recovery from laparoscopy‐assisted vaginal hysterectomy compared with abdominal and vaginal hysterectomy. Obstet Gynecol. 1997 Feb;89(2):304‐11. • Olive DL, Parker WH, Cooper JM, Levine RL. The AAGL classification system for laparoscopic hysterectomy. Classification committee of the American Association of Gynecologic Laparoscopists. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):9‐15 • Sarle R, Tewari A, Shrivastava A, et al. Surgical robotics and laparoscopic training drills. J Endouro 2004; 18:63‐67 • Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091‐5.
11 Disclosures Laparoscopic Surgery and It’s Complications I have no financial relationships to disclose
Ernest G. Lockrow DO FACOG, FACOOG Professor and Vice Chair Department of OBGYN Uniformed Services University Director MIGS Fellowship Walter Reed National Military Medical Center
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Objectives Background
Complications range 0.1% to 10% Evaluate the risks of laparoscopic surgery Employ risk reducing surgical techniques Approximately 50% entry technique Evaluate & treat complications of 20% to 25% unrecognized intraoperatively laparoscopic procedures Meta analysis –Neurologic – 1809 laparoscopy /1802 laparotomy – Vascular – benign GYN –Bowel – No difference major or minor – Urological (bladder, ureter) complications UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Contraindications to Laparoscopy Risk Factors
Absolute contraindications include Operative 0.1% to 18% vs Diagnostic 0.1% to Bowel obstruction 7% Ileus Extremes of body weight Peritonitis Anesthesia risk factors (Class III +) Intraperitoneal hemorrhage Distortion of pelvic anatomy Diaphragmatic hernia Previous abdominopelvic surgery Severe cardiorespiratory disease Pelvic pathology
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
12 Laparoscopic Surgery Risk Anesthesia Risk
Surgeon experience Cardiopulmonary function/Position – 3-5 fold increase in complications – Monitoring required – Consider central venous monitoring Unskilled surgical Assistance Fluid Balance – 5-8x more likely to incur a complication – Irrigation/blood loss Pnuemoperitoneum Faulty Instrumentation – GFR, SVR, vagal irritation – Diaphragmatic movement (PIP, MAP increase; FRC – Dull trocars reduced) – Faulty scope, light cords, electrosurgical – Hypercapnea equipment Subcutaneous Emphysema/ CO2 embolism
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Positioning Risk Technique Prior to the procedure an appropriate Steep Trendelenburg work-up is essential – Increases cardiac pre-load Indications for the procedure and its – Increase intrathoracic pressure appropriateness must be reviewed – Obese patients/impaired cardiopulmonary Informed consent should be obtained function – Aspiration Risk NG/OG The consent for operative laparoscopy should always contain permission for possible laparotomy
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Abdominal Entry Blind entry into the abdomen to induce pneumoperitoneum demands strict attention to detail The following three principles should be kept in mind: – Elevate the abdominal wall away from the aorta (if punctured it does not forgive) – Aim at the uterus (if punctured it forgives) – Aim at right angles to the skin close to the umbilicus
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
13 Abdominal Entry Complications of Trocar Entry
Correct entry can be judged by the free flow of saline (if Large Vessel Injury using a Veress needle), or an intra-abdominal pressure of 5-12mm Hg for initial flow 3-8 per 10,000 cases There is general agreement that an initial volume of 2L A major complication requiring immediate or an intra-abdominal pressure of 15 mm Hg is a laparotomy and a call for the vascular surgeon satisfactory endpoint prior to trocar entry Only the most skilled laparoscopist, or those In obese patients, it is advisable to distend the comfortable with open laparoscopy, should abdomen maximally to 20-25mm Hg attempt laparoscopy in a facility where immediate laparotomy is not feasible
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Vascular Injuries Diagnosis • Return of blood from Veress needle • Deterioration of vital signs • Unexplained volume of blood in peritoneal cavity • Reappearance of blood after aspiration Lynn CS J Reprod Med 27:217,1982
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14 Vascular Injuries Complications of Trocar Entry 30-50% of the surgical trauma which occurs during laparoscopy is due to vascular Direct entry techniques should not be used injuries in patients with: previous abdominal surgery Veress Needle accounts for 36% of the injuries morbid obesity Beware of the thin, athletic, nullipara Primary and Secondary trocars account for 32% Some surgeons advocate only the open Yuzpe AA J Reprod Med 35:485,1990 laparoscopy or Hasson technique
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Complications of Trocar Entry Other trocar site insertions
Know where the superior and inferior epigastric vessels run Transilluminate the abdominal wall and identify avascular spaces Insert additional trocars under direct visualization
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Complications of Trocar Entry If an epigastric vessel is encountered sometimes bleeding can be controlled with a thru and thru abdominal figure of eight stitch using an XLH needle Kleppinger forceps can sometimes cauterize the vessel Pelvic vessel injuries can be repaired with ligaclips if bleeding is minimal If the patient is unstable, laparotomy is necessary
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
15 Complications of Trocar Entry
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Complications of Trocar Entry
Port Placement
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Left Upper Quadrant Primary Trocar Insertion Complications of Trocar Entry Bowel injury Incidence: 0.03 - 0.39% NG tube, flat (no t-bird), 2 fingerbreadths below rib Recent systematic review found an overall Mid-clavicular line, cheat lat to avoid sup epigastric 11 blade, towel clips above and below incidence of bowel injury at 1 in 769 Resident holds inferior towel clip with left hand, shaft of Insertion of the insufflation needle and the initial Verres or optical trocar with right trocar are the most common cause Staff holds superior towel clip with left hand, manipulates CO2 tubing with right Delayed diagnosis mortality rate of 1 in 31 or 3.2%
Bowel Injury in Gynecologic Laparoscopy: A Systematic Review Obstetrics & Gynecology June 2015
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
16 Complications of Trocar Entry Complications of Trocar Entry Bowel injury Bowel injury Diagnosis Prevention • Stool on needle or trocar tip • Use of NG or OG tube • Fecal material in abdominal cavity • Lifting the abdominal wall • Hematoma on bowel serosa • Adequate pneumoperitoneum • Foul smell noted on introducing trocar • Care with use of monopolar electrosurgery • Make certain bowel is out of field of energy • Laparoscope introduced into intestinal lumen
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Complications of Trocar Entry Bowel injury
If immediately recognized, lacerations of the bowel by trocar and needle can be managed by direct suturing If peritonitis has become established, resection is necessary Perforations w/Veress needle: Observation and antibiotics
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Electrocoagulation As electrons enter the body they must return to ground In unipolar configurations, electrons go through the body to a ground plate If the ground plate is faulty, electrons seek ground through EKG leads to other smaller points of the patient’s contact with metal on the table causing skin burns
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
17 Electrocoagulation Electrocoagulation In response to unipolar bowel burns, bipolar forceps were designed; Bowel burn is rare (0.5 per 1000 cases) but ~ one prong of the forceps is insulated a serious complication requiring from the other except at the tip laparotomy ~ electrons flow between the tips of the Bowel perforation should be suspected in prongs all cases of continuing abdominal pain ~ no ground plate is required within 24 to 48 hours after laparoscopy ~ electrons stay in the fallopian tube ~ the patient is not part of the circuit
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Capacitive Coupling Capacitive Coupling
Omental burn during cholecystectomy
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Electrocoagulation Urologic complications A bipolar bowel burn probably involves no more Bladder Injury than 1 cm of tissue around the edges of the Most common reason for injury is lack of perforation so a simple resection can be performed catheterization With unipolar coagulation, a bowel perforation 1 Diagnosis: recognition of separation of cm in diameter would involve approximately 6 cm bladder mucosa or urine spillage around of compromised adjacent bowel trocar sleeve, appearance of gas in the foley – 10 - 12 cm resection and anastomosis would be bag or hematuria. required
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
18 Urologic complications Urologic complications Bladder Injury Bladder Injury Prevention Management • Depending on your laparoscopy skills the injury Visualization of the dome of the bladder can be repaired by direct suturing techniques when inserting the trocar • Need to drain the bladder for 7-10 days Recognize high risk patients • For small injuries (< 5mm) drainage may be (multiple c-sections etc) sufficient Modify insertion site if needed • Laparotomy may be needed to repair larger injuries
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Urologic complications Ureteral Injury
Patients usually present 48-72 hours postop with abdominal pain, peritonitis, leukocytosis, and fever Flank tenderness and hematuria are Rare Diagnosis is confirmed by IVP or CT w/contrast
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Urologic complications Urologic complications Ureteral Injury Prevention Ureteral Injury Prevention
Visualization of the ureter in the region of Use of hydro-dissection the uterosacrals is difficult, especially in the Use of Indigo carmine presence of endometriosis or adhesions Cautious use of electrocautery Laparoscopic uterine nerve ablation is Bipolor is preferred over monopolar associated with an increased risk of injury Prolonged coagulation can cause damage to Familiarization with the anatomy is key vascular supply and subsequent necrosis
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
19 UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
Urologic complications Complications of Laparoscopy Ureteral Injury Conclusion Management Recognition at the time of injury and • Repair should be done in conjunction with immediate repair will prevent morbidity the urologic surgeon Delayed diagnosis is the major cause of • It may be possible to place a stent increased morbidity • Laparotomy or robotic assistance may be Delayed recognition of injury makes required for : end to end reanastomosis, laparotomy more likely reimplantation, transureteral ureterostomy
UNIFORMED SERVICES UNIVERSITY UNIFORMED SERVICES UNIVERSITY of the Health Sciences of the Health Sciences Department of Obstetrics and Gynecology Department of Obstetrics and Gynecology
“Life is too short to make all of the References mistakes yourself... so learn from the mistakes of others” Lynn SC et al, Aortic perforation sustained at laparoscopy, J Reprod Med 1982 Apr;27(4):217-9 author unknown Yuzpe AA. Pneumoperitoneum needle and trocar injuries in laparoscopy: a survey on possible contributing factors and prevention. J Reprod Med 1990;35:485–90. Liarena, NC et al, Bowel Injury in Gynecologic Laparoscopy: A Systematic Review, Obstetrics & Gynecology June 2015 Vol 125 (6), 1407-1417 Xuezhi Jiang et al, The Safety of Direct Trocar Versus Veress Needle for Laparoscopic Entry: A Meta-Analysis of Randomized Clinical Trials, Journal of laparoendoscopic & advanced surgical techniques, 2012 vol22(4) 362-370 Ahmad G, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev 2008;16(2):
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20 Disclosures
Back to the Basics: • Consultant: Z Microsystems Hysteréctomie Vaginale • Other: Faculty for PACE Surgical Courses: Covidien
M. Jonathon Solnik, MD FACOG FACS Head of Gynaecology & MIS Mt. Sinai Hospital Associate Professor Dept Obstetrics & Gynaecology Faculty of Medicine ‐ University of Toronto
Objectives Why Vaginal Approach ?
• Demonstrate optimal position for purpose of • 400,000 inpatient hysterectomies in the US exposure during vaginal hysterectomy • 50% performed laparoscopically or vaginally • Vaginal approach stable ~23% • Describe technical challenges and means to • Utilization may rise with morcellation debate overcome these barriers • Equates to 200,000 women potentially affected
• Any MIS approach avoids morbidity & • Review methods for tissue extraction of larger mortality of abdominal surgery specimen
Why Vaginal Approach ? When to…, and when NOT too…
• VH associated with similar outcomes to LH Indications Contraindications (compared to AH) at a lower cost/time and • Benign pathology • Hx pelvic surgery ? • • with fewer urinary tract injuries POP Only cesarean ? • Pre‐malignant disorders • Uterus > 12 weeks ? • Needs BSO ? • ‘RH and single port hysterectomy should be • Pelvic arch < 90 degrees ? abandoned or further evaluated…’ • Chronic pelvic pain • Access to vessels • Pelvic mass • Reproductive cancer
21 Keys to Successful Surgery Why can this be a challenge ?
• Must be able to see what you are doing ! • Poor exposure… • Positioning • Peritoneal access (anterior/posterior entry) • Lighting • Maintain hemostasis • Retractors (do not over utilize) • Avoiding injury to visceral/vascular structures • Must know the anatomy (thru a keyhole) • Managing the large uterus • Peritoneal access • Removing adnexa • Must identify & manage complications • Must know how to extract large tissue volume
Feet wrapped or padded #1 ‐ EXPOSURE #2 ‐ Instruments Not hyper‐flexed or extended at knee and knee not resting on stirrup Not hyper‐flexed at hip
Buttocks slightly off end of bed
#2 ‐ Instruments #2 ‐ Instruments
22 #2: Other instruments #3 –Entry (Anterior)
• Briesky‐Navratil retractor • Right angle retractor • Lahey clamps • Double tooth tenaculum • Towel clips • Heaney‐Ballentine clamps • Zeppellin clamps • Right angle clamps
#3 –Entry (Anterior) Tricks to Anterior Entry
• Finger through posterior colpotomy to anterior cul de sac to delineate peritoneum • Retrofill bladder • Curved uterine sound through urethra (especially with procidentia) • Dissect bladder up (don’t need to enter anteriorly right away –be patient!)
As long as bladder is dissected cephalad, it is not necessary to enter anterior peritoneum right away!
Peritoneal entry Anterior & Posterior Entry
23 Posterior to Anterior Deaver Placement
#4 ‐ Hemostasis Ligasure Max
• Proper hand positioning during clamping – cutting –tying • Right angles to vessels
• Vessel sealing devices • Gyrus/Olympus: PK Seal: 7mm • Ligasure Std/Xtd/Max: reusable components • Ligasure Impact: 7mm • Enseal G2 Super Jaw • Altrus: bladeless
Enseal #5: The Large Uterus
• Wessels, wessles, wessles… • Then ‐ • Coring: don’t dig a hole; keep serosa exterior • Bivalving • Wedge extraction • Sequential vaginal myomectomy
24 Bivalve + Myomectomy Bivalving the Uterus
Vaginal Myomectomy Wedge Extraction
The Wedge… Coring
25 Coring #6: The Adnexa
• Don’t use oophorectomy as reason to avoid • Most ovaries can be removed vaginally • Endoloop
Traditional (one pedicle) technique Round Ligament Approach
• Mesosalpinx‐mesoovarium in one clamp • Thick pedicle • Retraction of vessels • Incomplete removal • Ureteral risk
#7: Complications VTE Prophylaxis
• Bleeding • Typically between utero‐ovarian and uterine • Posterior vaginal cuff • Inspect after hysterectomy prior to cuff closure • Bladder injury • Typically superior to trigone (not near ureter) • Avoid blunt dissection esp with prior cesarean • Always, always CYSTO (sterile water if no indigo) • Ureteral • Less common than with abdominal approach • Avoid with traction & retraction (lie at 2’ & 10’) • Bowel injury
26 Antimicrobials Tricks to Overcome the Tough Case
• Cephalosporins are the antibiotics of choice • Narrow vagina – episiotomy • Timed prior to induction of anesthesia • Pelvic adhesions –use anatomy; consider lap • Redose if surgery > 3hrs or EBL >1500ml • Large uterus – morcellation • Agents of choice in women with • Cervical elongation – delayed peritoneal entry hypersensitivity to penicillin or • Adnexectomy –proper technique cephalosporins: • Clindamycin plus gentamycin or quinolone CONSIDER OUTPATIENT HYSTERECTOMY • Metronidazole plus gentamycin or quinolone
Episiotomy (yuck…) Conclusions
References Special thanks to:
• Aarts JW et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev 2015 Erika Banks, MD • Geerts WH, et al. Prevention of venous thromboembolism. Andrew Sokol, MD Chest 2004 Barbara Levy, MD • Zakaria MA, et al. Outpatient vaginal hysterectomy. Obstet Rosanne Kho, MD Gynecol 2012 Marie Paraiso, MD • Surgical curriculum for residents in obstetrics and gynecology. CREOG 2002
27 • I have no financial relationships to disclose RETROPUBIC SLINGS
Douglas Miyazaki MD
Womancare, Novant Health Wake Forest University
SUI Surgery: Historical Singl Incision slings GOALS TO Subfascial Hammock Perspectives MonarcTM, BioArcTM , TOT • Review retropubic anatomy Tension-free biologic slings • Review Indications, Contraindications and BioArc™ SP Tension-free synthetic slings Complications of retropubic slings e.g. SPARC™, TVT™ 1995 Bone-anchored graft slings • Review proper surgical steps for sling placement e.g. In-Fast Ultra™/InteXēn™ • Review steps for cystoscopy Autologous/Graft PV slings • Understand and use the ACOG Assessment tool Needle Suspensions Raz, Stamey Retropubic operations Burch, MMK Anterior repairs
Retropubic Anatomy Retropubic Anatomy
28 Historical Components of SUI Pathophysiology • Loss of anatomic urethral support • Urethral Hypermobility (UH) – Weakness of pelvic structures that support urethral compression during increased abdominal pressure. • Intrinsic Sphincter Deficiency (ISD) • Deficiency of urethral intrinsic closing mechanism.
ISD & Loss of Urethral Support Traditional Concept of SUI A Clinical Continuum
• Pathophysiology SUI SUI ISD Present to some degree in all SUI cases
Loss of Urethral Support with UH Coexists with ISD in most cases UH ISD UH Loss of support with both UH & ISD ISD
Indications Contraindications
• Symptomatic SUI • Current UTI • Women who are having prolapse surgery with • Pregnancy known or suspected SUI • Current Anticoagulation • Structures in the Retropubic space that are a concern for injury
29 Complications Assess Course Manuel
• Bladder injury 3.5‐6% surgeon experience big • Pre Operative Preparation factor: experienced 1%, inexperienced 15‐34 % • Intra Operative Preparation • Voiding dysfunction 19‐47%, retention or incomplete emptying usually PVR>150cc • Operative Predissection • Urgency symptoms 5.9‐25% • Other: mesh exposure, vascular, bowel 0‐2.5% • UTI fairly common 0‐34%
Procedural Review Procedural Review • Operative: Dissection • Retract posterior vaginal wall • Operative: Passing Trocars • Identify mid‐urethra by placing traction on the Foley catheter • Confirm that patient is in Trendelenberg position • Place Allis clamps 1 cm on either side of mid urethra • Remove Foley catheter • Incise the epithelium with a 15‐blade with a full thickness vaginal wall –depth 0.3 • Insert 18‐Fr Foley with catheter‐guide to 0.7 cm (without hydrodissection) • Assistant deviates the bladder to the patient’s right • Initiate dissection with the blade –45 – degrees from the midline penetrating 1.5 • Insert trocar into right tunnel cm • Grasp the full thickness dissection with Allis • Remove all instruments from vagina • Insert Metz scissors and develop tunnel • Use the left hand to direct force to penetrate the anterior fibromuscular • Tunnel 4cm at a 45‐degree angle from midline and 45 –degrees from horizontal walle of th bladder. Needle is directed towards the ipsilateral shoulder
Procedural Review Procedural Review
• Operative: passing trocars • Perform cystoscopy • After penetrating this wall, (<5 cm), redirect needle so that it is in‐line with the sagittal plane of the patient • 70 degree lens • Advance trocar with the hand in the vagina directly behind the pubic bone until close to the suprapubic exit point. • Wiggle trocars to endure no muscularis injury • Transfer right hand to suprapubic area to assist penetrating skin • Pull through sheath and disengage the trocar • Repeat steps 4‐9 to insert trocar into left tunnel
30 Procedural Review Procedural Review
• Adjust sling tension • Close the vaginal wound • Remove slack from sling so that there is 1‐2mm between sling and urethra • Cut excess mesh arm below level of skin • Have patient cough, anesthesia administer Valsalva or apply suprapubic pressure • Close skin incisions • Place Jorgensen scissors (or similar spacer) between the sling and the urethra. Insert until past the bend and to the nut to ensure adequate spacing. • Slightly tighten sling although consider if patient doesn’t have their levator ani muscle due to anesthesia s to assist in continence • Remove sheath by breaking the middle attachment of the sheath (for Advantage TF) • Assistant to apply traction to the suprapubic portion of the sheath • Confirm that removal sheath did not tighten or distort sling
Video The ASSESSMENT
• Scoring Instructions: All scores will be in complete integers. No fractions are given. Participant will receive the full credit if the task is performed satisfactorily and 0 if either not performed or performed unsatisfactorily. • 10 areas of assessment
Pass/Fail Overall Skill Level
• Assesses tissue and instrument handling • Rates performance level of surgeon • Ability to function as primary surgeon: use of • Novice through Expert assistants, flow of operation and forward planning and overall knowledge of procedure
31 Thank You Dr.s Nihira and Barenberg References
• 1. Michael Baggish MK (2006) Atlas of Pelvic Anatomy and Gynecologic • 5. Daneshgari F, Kong W, Swartz M (2008) Complications of Mid Urethral Surgery. In., Second edn., pp 315‐332 Slings: Important Outcomes for Future Clinical Trials. The Journal of Urology 180 (5):1890‐1897. doi:10.1016/j.juro.2008.07.029 • 2. Muir TW, Tulikangas PK, Fidela Paraiso M, Walters MD (2003) The relationship of tension‐free vaginal tape insertion and the vascular • 6. Ogah J, Cody JD, Rogerson L (2009) Minimally invasive synthetic anatomy. Obstet Gynecol 101 (5 Pt 1):933‐936 suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 7 (4 • 3. Bent A (2008) TeLinde's Operative Gynecology. In., Tenth edn., pp 942‐ 958 • 7. Blaivas JG, Groutz A. In: Retik AB, Vaughan ED Jr, Wein AJ, et al, eds. Urinary Incontinence: Pathophysiology, Evaluation, and Management • 4. MD Walters MK (2007) Urogynecology and Reconstructive Pelvic Overview. Philadelphia, Pa: WB Saunders; 2002:1027–1052. Surgery. In., Third edn., pp 196‐210
“Extra slides not part of talk” FDA Public Health Notice October 20, 2008 • Recommendations: • Specialized Training Obtain specialized training for each mesh placement technique and be aware of its risks • Potential Adverse Events from Mesh Be vigilant for potential adverse events from mesh, especially erosion and infection • Complications Associated with Mesh Tools Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations
FDA Public Health Notice Second Notification –July 13, 2011 October 20, 2008 • Purpose of the Document: – Mesh is Permanent – Additional Surgery May be Required • Advise the public and medical community of complications related to – Surgery May / May Not Correct Complication transvaginal POP repair with mesh Inform patients that implantation of surgical mesh is permanent, and that some • Provide recommendations on how to counsel patients complications associated with the implanted mesh may require additional surgery that may or may not correct the complication • 13 questions patients should ask their doctor before they agree to – Potential for Serious Complications have a surgery in which mesh will be used Inform patients about the potential for serious complications and their effect on • “The FDA continues to evaluate the effects of using surgical mesh for the quality of life, including dyspareunia, scarring, narrowing of the vaginal wall (in POP treatment of SUI and will report about that usage at a later date.” repair) – Provide Written Copy of Labeling Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available
32 FDA September 2011 Recommendations in As a result of the September 2011 meeting, the 4 Part panel and FDA found…5 • For surgical mesh slings used for SUI: • Reclassification of transvaginal surgical mesh products for • The safety and effectiveness of multi‐incision slings is well‐established in POP to Class III (pre‐market approval) and to require clinical trials that followed patients for up to one‐year. Longer follow‐up manufacturers to conduct additional post‐market data is available in the literature, but there are fewer of these long‐term surveillance studies. studies compared to studies with one‐year follow‐up. • Surgical mesh devices for SUI remain in Class II. • The safety and effectiveness of mini‐slings for female SUI have not been adequately demonstrated. Presently, it is unclear how mini‐slings compare • No additional post‐market surveillance studies are to multi‐incision slings with respect to safety and effectiveness for treating necessary for retropubic and transobturator (TOT) slings. SUI. Additional studies may help the agency to better understand the • Pre‐market studies for new devices and additional post‐ safety and effectiveness of these devices. market surveillance studies for mini‐slings.
As a result of the September 2011 meeting, the As a result of the September 2011 meeting, the 5 5 panel and FDA found… panel and FDA found… • Erosion of mesh slings through the vagina is the most commonly reported • Mesh sling surgeries for SUI have been reported to be mesh‐specific complication from SUI surgeries with mesh. The average successful in approximately 70 to 80 percent of women at one reported rate of mesh erosion at one year following SUI surgery with mesh is approximately 2 percent. Mesh erosion is sometimes treated year, based on women’s reports and physical exams. Similar successfully with vaginal cream or an office procedure where the exposed effectiveness outcomes are reported following non‐mesh SUI piece of mesh is cut. In some cases of mesh erosion, it may be necessary surgeries. to return to the operating room to remove part or all of the mesh. • The use of mesh slings in transvaginal SUI repair introduces a • The long‐term complications of surgical mesh sling repair for SUI that are reported in the literaturee ar consistent with the adverse events reported risk not present in traditional non‐mesh surgery for SUI repair, to the FDA. which is mesh erosion, also known as extrusion. • The complications associated with the use of surgical mesh slings currently on the market for SUI repair are not linked to a single brand of mesh.
1. FDA. Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence CDRH October 2008; http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesM http://www.fda.gov/ eetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/u ObstetricsandGynecologyDevices/UCM271769.pdf Considerations about Surgical Mesh for SUI: cm061976.htm. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedure 2. FDA. Urogynecologic Surgical Mesh: Update on the Safety and s/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm#.U Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse CDRH WLj7d40J9E.email July 2011. 3. FDA. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse July 13, 2011. http://www.fda.gov/MedicalDevices/Safety/Alerts and Notices/ucm262435.htm.
33 $$$$$$$ $$$$$$$
• About Surgical Watch • 18,176 Ethicon pelvic mesh cases SurgicalWatch.com provides up to date • 17,812 AMS mesh lawsuits information on lawsuits involving defective • 12,004 Boston Scientific complaints • 8,555 Bard Avaulta mesh claims medical devices that affect US patients and • 1,468 Coloplast mesh lawsuits consumers. • 195 Cook Medical cases • 52 Neomedic mesh lawsuits
$$$$$$$ $$$$$$$
• Last March, Bloomberg reported that a $16 • C.R. Bard Inc. agreed to pay more than $200 million to resolve at least million Coloplast mesh settlement was reached between 3,000 cases by women injured by the company’s vaginal‐mesh inserts, five people familiar with the accord said. parties in January of 2014 that would effectively resolve an • The settlement resolves about a fifth of the outstanding suits related to estimated 400 legal complaints. Under the provisions of the the implants, agreement, each claimant would secure roughly $40,000 a • Bard, based in Murray Hill,w Ne Jersey, added $337 million to its $660 piece to compensate for injuries and economic losses million reserve for product‐liability cases while acknowledging it had associated with products such as the Aris‐ Transobtrurator resolved 2,800 cases over “Women’s Health Products,” according to a July and Novasilk‐Synthetic mesh systems. 24 filing with the U.S. Securities and Exchange Commission.
$$$$$$$ $$$$$$$
• Boston Scientific to pay $119 million to settle some mesh • On April 30, Endo Health Solutions –parent company claims of American Medical Systems – agreed to settle • http://www.modernhealthcare.com/article/20150428/NEW approximately 20,000 lawsuits involving vaginal S/150429889 mesh devices sold by their AMS subsidiary. The $830 • 4/28/2015 — Boston Scientific Corp. has agreed to pay $119 million vaginal mesh settlement marked the largest million to settle nearly 3,000 cases and claims over its transvaginal surgical mesh products, the company disclosed accord achieved thus far in the mesh multidistrict Tuesday in a filing with the Securities and Exchange litigation. Commission
34 CULTURAL AND LINGUISTIC COMPETENCY
Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).
US Population California Language Spoken at Home Language Spoken at Home
Spanish English Spanish
Indo-Euro English Indo-Euro Asian Other Asian
Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%
California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org
Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.
Executive Order 13166,”Improving Access to Services for Persons with Limited English Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.
Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.
~
If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.
35