Erosion of Woven Polyester Pubovaginal Sling. The Dalkon Shield. William Stewart Halsted, M.D

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1 Who Are We and Who Should We Be As 21 st Century Pelvic Reconstructive Surgeons? Daniel K. Roberts Lecture June 14, 2013 Wichita, KS Bob L. Shull, M.D. Professor of Obstetrics and Gynecology Scott & White Clinic and Hospital Texas A&M University Health Sciences Center Temple, Texas USA Learning objectives My wife and I have no financial disclosures to make At then end of the presentation you will: 1. Know you have at least 2 roles you serve 2. Know there is legitimate t concern regarding the use of mesh kits for reconstructive vaginal surgery 3. Know how to identify specific anatomic pelvic support defects Pretest Are you a: a) Gynecologic surgeon b) Learned intermediary c) Fiduciary for your patient d) Thought leader e) Plaintiff s lawyer f) Teacher g) Mentor Why Does It Matter? 1

2 We Are In The Middle of A Perfect Storm: Surgeons who want to be on the leading edge Patients who are willing to be alpha test subjects Industry who wants to sell products Poor regulatory oversight Potent Medico-Legal system Timeless Qualities of a Surgeon Timeless Qualities of a Surgeon Diligence 2

3 William Stewart Halsted, M.D Surgeon-in-chief Johns Hopkins Hospital Professor of Surgery Johns Hopkins University School of Medicine The past: That which will not tell us what we ought to do what we ought to avoid. -José Ortega y Gossett Ignaz Simmelweis Savior of Mothers Childbed fever Wash your hands in chlorinated lime solutions The Dalkon Shield Erosion of Woven Polyester Pubovaginal Sling Purpose: Use of synthetic materials provides a theoretical advantage in that no graft harvesting is necessary. Major risks of synthetic material use are erosion and infection of the sling. We report on erosion of woven polyester slings treated with pressure injected bovine collagen (ProteGen*) which required removal. Results: A total of 34 women required removal of the polyester sling secondary to erosion, infection or pain. Kobashi KC, Dmochowski R, Mee SL, et.al. The Journal of Urology, 1999 Dec; 162,

4 Total Pelvic Mesh Repair: A Ten-Year Experience Results: From January 1990 to December 1999, 236 females had total pelvic mesh repair, and 205 (87 percent) were available for follow-up. Reoperation rate because of complications of the total pelvic mesh repair procedure was 10 percent. Additional surgical procedures at various intervals subsequent to total pelvic mesh repair have been performed in 36 percent of patients to further improve bladder function and have been performed in 28 percent of patients to improve anorectal function. Timeless Qualities of a Surgeon Diligence Doing the Right Thing Sullivan ES, Longaker CJ, Lee PY Dis Colon Rectum 2001 Jun;44(6): Timeless Qualities of a Surgeon Diligence Doing the Right Thing First Do No Harm Hippocratic Oath Timeless Qualities of a Surgeon Diligence Doing the Right Thing First Do No Harm Harm Hippocratic Oath Ingenuity Thomas Hepburn Retropubic Urethropexy Ulf Ulmsten Tension Free Vaginal Tape Societal issues which presently effect and will continue to influence the surgeon s behavior. 4

5 Societal issues which presently effect and will continue to influence the surgeon s behavior. Communication Connectivity Societal issues which presently effect and will continue to influence the surgeon s behavior. Communication Connectivity Medico-Legal Systems Societal issues which presently effect and will continue to influence the surgeon s behavior. Physician Industry Relationships Communication Connectivity Medico-Legal Systems Physician-Industry Relationships Reports: Data on Vioxx was misused Corporate and government documents from Vioxx lawsuits indicate that the drug's maker, Merck & Co., apparently downplayed evidence showing the painkiller tripled the risk of death in Alzheimer's-prone patients, researchers report today. Reports: Data on Vioxx was misused "The drug industry appears to treat scientific data as if they were a marketing tool," says the University of Washington's Bruce Pasty, a co-author of one of the JAMA articles. "That's not appropriate." USA Today:Wednesday, April 16, 2008 USA Today:Wednesday, April 16,

6 Reports: Data on Vioxx was misused The Vioxx disclosures are "just the tip of the iceberg," JAMA editor Catherine DeAngelis says. "I've been sitting in this office for eight years, watching physicians and clinical researchers be used by pharmaceutical companies in ways that can end up with patients being hurt. Physicians have allowed it to happen, and it's time to stop." USA Today:Wednesday, April 16, 2008 Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence FDA U.S. Food and Drug Administration 10/21/2008 What to Advise Patients About Hernias Commentary by Edward H. Livingston, MD What advice should primary care clinicians give to patients regarding repair of abdominal wall hernia? Do all hernias need repair? If the hernia is repaired, should mesh be used? If so, why, and what are the risks? Is the operation best performed laparoscopically? JAMA, September 1, 2010 Vol 304, No 9 Following diagnosis of a hernia, patients are referred to surgeons for repair to reduce hernia-related related symptoms and to avoid complications. It was assumed, but never proven, that the risks of hernia surgery were less than those posed by the risk for complications that might be attributable to hernias. This study showed that the commonly accepted approach that all hernias require repair is no longer valid. JAMA, September 1, 2010 Vol 304, No 9 Mesh is not risk free and can cause chronic pain or become infected. The pendulum has swung too far in favor of mesh implantation, and it is commonly placed to reinforce congenital umbilical hernias or other abdominal wall hernias that are surrounded by healthy, durable fascia in which reinforcement of the defect is not necessary. Placement of mesh on the inside of the abdominal wall adds risk because it might contact the bowel, which tends to attach to mesh and may result in bowel obstruction, mesh infection, and fistula formation. JAMA, September 1, 2010 Vol 304, No 9 Major complications were more frequent in the laparoscopic group compared with the open surgery group (4.4% vs 1.4%, respectively), and were mostly attributable to bowel injuries. There was no statistical difference at 2 years for hernia recurrence rates (12.5% for the laparoscopic group vs 8.2% for the open surgery group). Similarly, quality-of of-life and pain scores were similar between groups in the long term. In another well-executed executed randomized controlled trial comparing laparoscopic with open groin hernia operations, Neumayer et al reported similar results for hernia outcomes, with somewhat better results for open operations. JAMA, September 1, 2010 Vol 304, No 9 6

7 Clinical Opinion -Urogynecology Use of vaginal mesh in the face of recent FDA warnings and litigation Use of vaginal mesh in the face of recent FDA warnings and litigation Many gynecologists may be hesitant to continue offering vaginal mesh procedures secondary to recent FDA warnings and the many advertisements from plaintiff attorneys seeking patients who have experienced complications from their mesh placements. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Use of vaginal mesh in the face of recent FDA warnings and litigation Learned intermediary doctrine and preemption The learned intermediary doctrine shifts the liability of harm caused by a medication or medical device away from the manufacturer and onto the physician prescribing or using the product. Overall, under learned intermediary doctrine, if a manufacturer adequately warns a physician of a product s potential complications and risks, then they do not possess the legal duty to warn patients of possible dangers associated with their product. Instead, the duty to warn falls on the physician prescribing the product. Use of vaginal mesh in the face of recent FDA warnings and litigation Learned intermediary doctrine and preemption For example, in Linsley v C.R. Bard Inc,, the manufacturer of Marlex mesh used the learned intermediary doctrine to shift liability of the duty to warn patients of potential complications onto physicians. This suit stated that mesh was and is a prescription medical device, which requires that it be used only upon order of a qualified physician, thus the warning required is not to the general public or to the patient, but to the prescribing physician. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Use of vaginal mesh in the face of recent FDA warnings and litigation Learned intermediary doctrine and preemption Johnson & Johnson (New Brunswick, NJ), the parent company of Ethicon (Somerville, NJ), a manufacturer of mesh used in tension-free midurethral tape procedures, has used the learned intermediary doctrine to shift liability away from itself in suits involving its pharmaceutical product, the Ortho Evra Patch. If the learned intermediary doctrine is used by a company in suits involving transvaginal mesh, gynecologists can attempt to redirect responsibility to the manufacturer by showing that they did not receive adequate warning of risks associated with the use of their product. However, with the recent FDA warnings, it will be difficult for gynecologists to successfully argue they were not aware of the potential complications involving the use of mesh in vaginal reconstructive surgery. Use of vaginal mesh in the face of recent FDA warnings and litigation Learned intermediary doctrine and preemption Alternatively, a better choice for gynecologists defending themselves from liability is to assure there is documentation in the medical record that the patient was properly informed of the potential complications that may be encountered with mesh use in vaginal reconstructive surgery. Another recent development that significantly impacts existing and deters future lawsuits against manufacturers of medical devices is the 2008 US Supreme Court case Riegel v Medtronic Inc. In this case, the US Supreme Court held that the preemption clause enacted in the Medical Device Amendments, 21 USC 360k (1976), bars claims challenging the safety and effectiveness of a medical device given premarket approval by the FDA. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. 7

8 Use of vaginal mesh in the face of recent FDA warnings and litigation Learned intermediary doctrine and preemption As a result, patients injured by a medical device previously approved by the FDA have little recourse other than to sue their physicians. Use of vaginal mesh in the face of recent FDA warnings and litigation Fiduciary responsibility The relationship between the physician and the patient is one of fiduciary i responsibility, meaning that t the patient t seeks out a physician, trusting that the physician possesses a level of knowledge necessary to inform the patient. This is essential when providing informed consent of surgical procedures. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Use of vaginal mesh in the face of recent FDA warnings and litigation Potential causes of action against physicians Overall, there are 2 major potential instances where physicians may find themselves liable in a lawsuit surrounding the use of transvaginal mesh. The first is basic medical negligence in using mesh that is knowingly harmful to the patient, and the second is failure to obtain adequate informed consent for the procedure. Letters to the Editor - AJOG Informed consent cannot be obtained for use of vaginal mesh Mucowski SJ, MD; Jurnalow C, MD; Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol 2010;203:103 e1-4. Anne M. Weber, MD, MS, American Journal of Obstetrics & Gynecology March 2011 e6 The New England Journal of Medicine Original Article Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse Daniel Altman, M.D., Ph.D., Tapio Väyrynen, M.D., Maria Ellström Engh, M.D., Ph.D., Susanne Axelsen, M.D., Ph.D., and Christian Falconer, M.D., Ph.D., for the Nordic Transvaginal Mesh Group N Engl J Med 364;19 NEJM.ORG May 12, 2011 Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse Background The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. N Engl J Med 364;19 NEJM.ORG May 12,

9 Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse Conclusions As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT ) N Engl J Med 364;19 NEJM.ORG May 12, 2011 Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness Of Transvaginal Placement for Pelvic Organ Prolapse July 2011 Executive Summary In October 2008, the FDA issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, and to provide recommendations on how to mitigate risks and how to counsel patients. Following the PHN, the FDA continued to monitor the outcomes of urogynecologic use of surgical mesh. A search of the FDA s Manufacturer and User Device Experience (MAUDE) database from the last 3 years (January 1, 2008-December 31, 2010), identified 2,874 Medical Device Reports (MDRs) for urogynecologic surgical meshes, including reports of injury, death, and malfunctions. Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs. Overview In 1996, the FDA cleared the first surgical mesh product specifically for use in SUI, and in 2002, the FDA cleared the first surgical mesh product specifically for use in POP. Over the next few years, surgical mesh products for transvaginal POP repair became incorporated into kits that included tools to aid in the delivery and insertion of the mesh. Surgical mesh kits continue to evolve, adding new insertion tools, tissue fixation anchors, surgical techniques, and absorbable and biologic materials. Clinical performance data typically has not been used to support clearance for POP or SUI urogynecologic mesh products. Safety The literature review identified the following safety concerns with transvaginally placed surgical mesh for POP repair: Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh. Adverse events associated with transvaginally placed mesh can be life-altering for some women. Sequelae (e.g., pain) may continue despite mesh removal. Safety cont d Mesh-associated complications are not rare. The most common mesh-related complication experienced by patients undergoing transvaginal POP repair with mesh is vaginal mesh erosion. Based on data from 110 studies including 11,785 women, approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery. More than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries. 9

10 Safety cont d Mesh contraction, causing vaginal shortening, tightening, and/or vaginal pain in association with transvaginal POP repair with mesh, is increasingly reported in the literature. New onset SUI has been reported to occur more frequently following mesh augmented anterior repair compared to traditional anterior repair without mesh. Safety cont d Transvaginal surgery with mesh to correct vaginal apical prolapse is associated with a higher rate of complication requiring reoperation and reoperation for any reason compared to traditional vaginal surgery or sacral colpopexy. Abdominal POP surgery using mesh (sacral colpopexy) appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh, with the median vaginal mesh erosion rate reported at 4 percent within 23 months of surgery. Effectiveness The literature review found that while transvaginal POP repair with mesh often restores anatomy, it has not been shown to improve clinical benefit over traditional non-mesh repair, as evidenced by the following key findings: Transvaginal apical or posterior repair with mesh does not appear to provide any added benefit compared to traditional surgery without mesh. Effectiveness cont d There does appear to be an anatomic benefit to anterior repair with mesh augmentation. This anatomic benefit may not result in superior symptomatic outcomes or lower rates of repeat surgery for recurrent prolapse compared to traditional POP repair without mesh. Patients who undergo traditional POP repair without mesh have equivalent improvement in quality of life when compared to patients who undergo transvaginal POP repair with mesh. Effectiveness cont d Compared to traditional vaginal surgery without mesh, abdominal apical prolapse repair with mesh (sacral colpopexy) results in less recurrent prolapse, p although it has not been shown to reduce the rate of repeat surgery for recurrent prolapse. Recommendations for Health Care Providers The FDA encourages health care providers to: Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications. Choose mesh surgery only after weighing the risks ik and db benefits of surgery with mesh versus all surgery and non-surgical alternatives. 10

11 Recommendations for Health Care Providers cont d Consider these factors before placing surgical mesh: Surgical mesh is a permanent implant that may make future surgical repair more challenging. A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain. Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh. The past: That which will not tell us what we ought to do what we ought to avoid. -José Ortega y Gossett Lesson 1 PARATUS SEMPER DISCERE ALWAYS PREPARED TO LEARN! Learning is by nature curiosity prying into everything, reluctant to leave anything, material or immaterial unexplained. Philo of Alexandria 11

12 I am glad of all the details, whether they seem to you to be relevant or not. By a man s finger-nails, nails, by his coat- sleeve, by his boots, by his trouser- knees, by the callosities of his forefinger and thumb, by his expression, by his shirt-cuffs by each of these things a man s calling is plainly revealed. ea ed That all united should fail to enlighten the competent inquirer in any case is almost inconceivable. -From A Study in Scarlet Lesson 2 The fundamentals of surgical repair of any hernia are to reduce it and maintain its reduction by supporting structures. Williams GA, Richardson AC. Am J Obst & Gynec, September, 1952; Vol 64, Number 3, pages Lesson 3 The eyes can t see what the mind don t (sic) know! 12

13 Lesson 4 Careful examination and evaluation of patients prior to operative procedures cannot be too strongly gy stressed. Define Normal Lesson 5 Sites to be described Conditions of examination Williams GA, Richardson AC. Am J Obst & Gynec, September, 1952; Vol 64, Number 3, pages Requirements for Improvement Define Normal Sites to be described Conditions of examination 13

14 Goals Assessment of specific sites Description of support loss with maximum stress Anatomic abnormalities contributing to support loss Reproducible Understandable Usable Improves patient care Staging Oncology Clinical Surgical Infertility Surgical 14

15 Normal Physical Exam Genital hiatus Closed Urethral meatus parallel to the floor no evidence of urethral prolapse/caruncle Anterior compartment Cervix/Cuff Posterior compartment Neuromuscular assessment of pelvic floor Gynecologic pelvimetry Normal Pelvic Exam 15

16 Cuff and uterosacral ligaments Gynecologic pelvimetry Abnormal Pelvic Exam At Rest Straining Open genital hiatus Lesson 6 Anterior Compartment Defects Transverse Cystocele Am J Obstet Gynecol 2002, 187:

17 Anterior Compartment & Apical Defect Post Hysterectomy Cuff Prolapse Posterior Compartment Defects Posterior Compartment and Apical Defects Perineal Descent Rectal Prolapse 17

18 Lesson 7 The treatment of prolapse of the vagina following a hysterectomy is demanding of the resourcefulness of the surgeon. Lesson 8 In spite of careful preoperative examination and meticulous surgery there will be a certain number of failures. Williams GA, Richardson AC. Am J Obst & Gynec, September, 1952; Vol 64, Number 3, pages Williams GA, Richardson AC. Am J Obst & Gynec, September, 1952; Vol 64, Number 3, pages It is one of those instances where the reasoner can produce an effect which seems remarkable to his neighbor because the latter has missed the one little point which is the basis for the deduction. 18

19 Superior Segment (Supra vaginal defects) Cardinal- Uterosacral Ligament Complex Defect: Repair: Uterosacral Ligament U-S ligament plication/suspension Sacral fixation U-S Cardinal Ligament Shortening U/S-cardinal ligaments Complex Sacrospinous fixation Sacrocolpopexy Cul-de-sac Excision sac and cerclage Uterosacral ligament plication Puborectalis plication/ interposition Anterior Segment - Urethra, Bladder Defects Defect: Repair: Midline Anterior colporrhaphy Excision urethral diverticulum Para urethral Retropubic suspensions (Lateral a detachment) e t) Marshall-Marchetti-Krantz a Marchettia a t Burch Paravaginal (Lateral Vaginal Wall) Combined Needle suspensions (Pereyra, Stamey, Raz) Sling procedures Para vesicle Paravaginal repair (Lateral detachment) (Retropubic or vaginal reattachment) Superior Reattachment to cervix or cuff Defect: Midline Posterior Segment Repair: Posterior colporrhaphy Lateral detachment t Pararectal reattachment t Superior PERINEAL DEFECTS: Anal sphincter laceration Reattachment to cuff Perineorrhaphy Sphincteroplasty Lesson 9 Surgical Techniques for Pelvic Support Defects Must be Individualized Depending on the Patient s Expectations Support defects Functional status of urethra, bladder, bowel, and vagina 19

20 Lesson 10 Surgical techniques for pelvic support defects must be individualized depending on the surgeon s skills PARATUS SEMPER DOCERE ALWAYS PREPARED TO TEACH! Lesson 11 Personalized care of the surgical patient by nurse and doctor Richardson AC, Graham EE Am J Obstet Gynecol, Vol 115, Issue 7, pp 962-5, 1973 Lesson 12 Lesson 13 Patients are eager to find a friendly face when they enter the operating room. Richardson AC, Graham EE Am J Obstet Gynecol, Vol 115, Issue 7, pp 962-5, 1973 Mentor and Friend 20