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1 THE TUMULTUOUS MARRIAGE OF MORCELLATION AND MIS; CAN OR SHOULD THIS RELATIONSHIP BE SAVED? Julian C. Schink MD Chief of Women s Health Spectrum Health Medical Group Grand Rapids, MI Disclosure! I have no financial conflict of interest.! Every effort is made in this presentation to feature generic products whenever available.! Product names are avoided whenever possible but may slip into images without representing my endorsement of those products! Some products are discussed objectively when no generic equivalent is available, this is not an endorsement of the product.! Only FDA indications for products will be presented. Learning Objectives: 1.! Describe the scientific basis for benign or malignant tumor implantation within the peritoneal cavity. 2.! Characterize the risk of tumor recurrence as well as visceral and vascular injury associated with power morcellation. 3.! Choose alternative strategies to power morcellation which preserve the use of MIS for the management of benign malignant, or undefined neoplasms. 3(

2 History of Power Morcellation! 1995: The FDA approves the first laparoscopic power morcellator with a gynecologic indication for use through its 510(k) process. Since then, the agency has cleared about 2 dozen such devices for use in gynecology.! 2003 Awareness of morcellation misadventures rises.! 2012 Researchers from Brigham and Women s publish report documenting risks of peritoneal spread.! October 2013 Amy Reed MD has surgery at Brigham and Women s with morcellation of occult leiomyosarcoma.! April 17, 2014 (FDA) announcing that it discourages the use of laparoscopic power morcellators in most hysterectomy and myomectomy procedures because of the risk of spreading unsuspected cancerous tissue. Complications associated with Power Morcellation! Mechanical/traumatic injury to:! Bowel! Bladder! Vasculature! Intraperitoneal spread of neoplasm! Benign! leiomyomatosis! dermoids! Tumors of uncertain malignant potential (STUMP)! Endometrial cancer! Uterine sarcoma! Ovarian Cancer! Especially stromal tumors such as granulosa cell Morcellator Misadventures! Reports began in the early 21 st century! Laparoscopic Morcellator-Related Injuries The Journal of the American Association of Gynecologic Laparoscopists, August 2003, Magdy P. Milad, M.D. a,,! eg:laparoscopic morcellator-related complications. J Minim Invasive Gynecol May-Jun;21(3): Milad MP 1, Milad EA 2.! During the past 15 years, 55 complications were identified. Injuries involved the small and large bowels (n = 31), vascular system (n = 27), kidney (n = 3), ureter (n = 3), bladder (n = 1), and diaphragm (n = 1).! What is the true incidence?! Why aren t these reliably captured by the MAUDE database? 1(

3 The sudden increased awareness of disseminating malignancy! Amy Reed, MD, an anesthesiologist at Beth Israel Hospital in Boston, and mother of 6.! Hysterectomy with morcellation. But things didn't go as expected.! Dr. Reed learned a few days after the surgery performed at Brigham and Women s Hospital that she had a uterine leiomyosarcoma and the morcellation may have worsened her prognosis by spreading the cancer around her abdomen. Peritoneal Spread of Neoplasms! From , 1091 instances of uterine morcellation were identified at BWH.! Unexpected diagnoses of leiomyoma variants or atypical and malignant smooth muscle tumors occurred in 1.2% of cases using power morcellation for uterine masses clinically presumed to be fibroids! endometrial stromal sarcoma (ESS), one cellular leiomyoma (CL), six atypical leiomyomas (AL), three smooth muscle tumor of uncertain malignant potential (STUMPs), and one leiomyosarcoma (LMS).! Furthermore, when examining follow-up laparoscopies, both from in-house and consultation cases, disseminated! disease occurred in 64.3% of all tumors Seidman, et al 7(

4 Biologic basis of tumor implantation! Implantation of a tumor graft is based on:! Tumor fragments retain cell-cell interactions and architecture which maintains its microenvironment.! Orthotopic implantation (a site similar in anatomic location) has higher engraftment rate.! Experience from xenograft placement in nude mice finds transplanting 5x5x5 mm tumor to be optimal.! A biologically compatable autograft does not invoke much immune response.! Essential implantation kinases such as VEGF, PDGF, adrenomedulin, and fibroblast growth factor receptor are present in both benign and malignant uterine neoplasms. VEGF function Likelihood of Morcellating an occult cancer! Previous underestimated risk of sarcoma! Was reported as 1;10,000! Parker, etal : Rapidly enlarging fibroids : 1;850! Lack of sensitive or accurate predictive test or clinical circumstance! Other occult malignancies! Endometrial cancer! Ovarian cancer! Neither our eyes nor our imaging accurately predicted the cancer. Are we myopic or just seeing what we hope is there? 8(

5 Frequency of Morcellating Malignancy! Seidman: Seidman et al. PLOS: 1.2% of cases! Peritoneal Dissemination of Morcellation Lesions! The data demonstrate that following power morcellation with an unexpected diagnosis of leiomyoma variant, atypia, or malignancy, exploratory laparoscopy will find evidence of peritoneal dissemination 64.3% of the time.! FDA: 1:352 sarcoma and 1:498 LMS! AAGL abstract: Portland study 4 or 6% cancer morcelated! Ob/Gyn: 2.7% risk of unexpected malignancy in Michigan! If that is not enough, what is the implantation rate of benign neoplams leading to intraperitoneal benign multifocal disease? FDA Guidance! Key points:! Risk 1:352 sarcoma and 1:498 LMS! The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids.! If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient s longterm survival.! With regard to the spread of unsuspected cancer when using laparoscopic power morcellation for hysterectomy or myomectomy in women with symptomatic uterine fibroids, the FDA considers this to be reportable as a serious injury. Unanticipated Pathology in the Uterine Specimen at the Time of Robotic Sacrocolpopexy M. Pendergrass, B. Osmundsen Journal of Minimally Invasive Gynecology, Vol. 20, Issue 6, S55 Published in issue: November, 2013! Study Objective: To evaluate the prevalence and risk factors of! unanticipated uterine pathology at the time of robotic sacrocolpopexy, Design: This is a cross-sectional prevalence study of women undergoing a hysterectomy at the time of sacrocolpopexy between March 2010 and March 2012.! Patients: 119 women who underwent a hysterectomy Of these, 88 underwent supracervical hysterectomy with morcellation and 31 underwent total hysterectomy.! a mean age of 59, a mean BMI of 27, and an 11% prevalence of diabetes.! The prevalence of unanticipated uterine pathology was 6% (95% CI 2%-11%). Of these seven patients, three had complex endometrial hyperplasia with atypia, and 4 had endometrial cancer.! Conclusion: Our findings bring to light the considerable risk of morcellating unanticipated uterine pathology in a patient without a history abnormal uterine bleeding. 4(

6 Obstetrics and Gynecology: February 2015! Objective:..define incidence of unexpected gynecologic malignacies among women who underwent hysterectomy for benign indications.! Methods: Michigan Surgical Quality Collaborative. 1/1/13-12/8/13. Benign surgical indications. Endometrial and cervical atypia/dysplasia excluded.! 6360 Hyst s for benign indication.! Incidence of unexpected cancer was n=172 = 2.7%! Ovarian cancer, fallopian tube, etc n=69 = 1.08%! Endometrial cancer n=65 = 1.02%! Uterine sarcoma n= 14 = 0.22%! No difference in the mean age, 46.8y vs 47.0 What about benign implants? Obstet Gynecol 2015;125: Professional Organizations Positions! SGO- Fewer than one out of 1000 women who undergo hysterectomy for leiomyomas will have an underlying malignancy!.there is no reliable method to differentiate benign from malignant leiomyomas (leiomyosarcomas or endometrial stromal sarcomas) before they are removed. AAGL-These risks should be weighed in the context of the benefits of a minimally invasive approach as well as the risks and benefits of expectant management or laparotomy.! ACOG- a national prospective morcellation registry is needed. 9(

7 Ethics and Shared Decision Making! FDA: Thoroughly discuss the benefits and risks!be certain to inform the small group of patients for whom laparoscopic power morcellation may be an acceptable therapeutic option that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.! What is your obligation?! What is the risk of causing death?! Can you convey this risk clearly? Informed consent: Risks! From AAGL tissue extraction task force! Dissemination of malignant tissue in the peritoneal cavity, which may worsen prognosis.! Dissemination of benign tissue, which may result in untoward health consequences, including the need for re-operation or additional treatments.! Rendering complete pathologic evaluation of a tissue specimen more difficult.! Injury to adjacent organs unique to the technique of morcellation.! These risks should be weighed in the context of the benefits of a minimally invasive approach as well as the risks and benefits of expectant management or laparotomy. Shared Decision Making! What are your responsibilies?! Shared decision making (SDM) is a collaborative process that allows patients and their providers to make health care decisions together, taking into account the best scientific evidence available, as well as the patient's values and preferences.! Patients and clinicians have different expertise when it comes to making consequential clinical decisions. While clinicians know information about the disease, tests and treatments, the patient knows information about their body, their circumstances, their goals for life and healthcare. It is only collaborating on making decisions together that the ideal of evidence-based medicine can come true. This process of sharing in the decision-making tasks involves developing a partnership based on empathy, exchanging information about the available options, deliberating while considering the potential consequences of each one, and making a decision by consensus. :(

8 Bits and Pieces: The Ethics of Uterine Morcellation Arora, Kavita Shah; Spillman, Monique; Milad, Magdy Obstetrics & Gynecology. 124(6): , December 2014!!develop a more robust and nuanced understanding of informed consent for the use of morcellation in benign gynecologic surgery. Ultimately, as physicians, we must remain steadfast in our dedication to the use of evolving technologies to better patient health in a safe and ethical manner that is well-studied, informed, and implemented with appropriate training and precautions. Alternative Strategies! Mechanical (cold knife) morcellation! Vaginal or extracorporeal morcellation! Bag it! Mini-Lap! Versatile access devices Gelpoint Retractor!Alexis retractor!self sealing removable septum!accommodates multiple instruments!incision 1.5 to 7cm ;(

9 Single Incision Total Laparoscopic Hysterectomy Using the GelPOINT Access Platform J.E. Fisher, R.P. Baxix Beumont Health Systems, Royal Oak, Michigan! Total Laparoscopic Hysterectomy with robotic assistance, while technically challenging, is feasible and safe using the Applied Medical GelPOINT Advanced Access Platform. With improved cosmetic results and potential improvement in patient satisfaction, single incision surgery may offer significant advantages over multi-port procedures, while the concurrent use of the robot gives the surgeon the ability to address more complex and difficult pathology than with traditional laparoscopic instrumentation.! November December, 2013 Volume 20, Issue 6! Journal of Minimally Invasive Gynecology GLAD! Versatility of Gelpoint laparoscopy access device (GLAD) as a minimally invasive approach for various gynecologic oncology procedures E. Chapman-Davis, J. Schink, D. Singh, B. Buttin, J.R. Lurain, M.P. Lowe! 29 patients March 2010-March 2011! Mean incision 5.2cm (3-8cm)! Mean tumor size 11.25cm (5-40cm; >10cm 9 patients)! 100% of masses removed without spillage or incision enlargement AAGL guidance regarding bags/pouches Additionally, there are technical challenges associated with the approach:! Variability in size, shape, and weight of uterine tissue makes placing the specimen into the bag challenging.! Puncturing the bag in some cases of multiport laparoscopy can be a risk.! Visualization of the mass within the bag may be suboptimal.! Visualization of vital structures external to the bag may be obscured.! Advanced laparoscopic skills are required to avoid complications performing EMM inside a bag. <(

10 New Strategies! Large bags brought to the incision for essential extracoporeal morcellation or piecemeal extraction! Most commonly using some variation of alexis retractor or similar device.! Prototypical video: Evolving protected morcellation Summary! Intracoporeal Morcellation of the Uterus of Myomas carries with it real risk of disseminating either malignant or benign neoplasm.! These risks were previously under-reported and did not reach public awareness until recently, and then by a victim rather than by our scientific or manufacturing community.! Informed consent and Shared decision making challenge our ability to clearly explain the risk.! Alternatives include: vaginal extraction, mini-lap, abdominal access devices. 32(

11 FDA Statement! UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication The following information updates our April 17, 2014 communication.! Date Issued: Nov. 24, 2014! Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma. FDA continued! If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.! Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.! Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer, and the recommendation that doctors share this information directly with their patients, are part of FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels. FDA guidance! Recommendations for Health Care Providers:! Be aware of the following new contraindications recommended by the FDA;! Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or minilaparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)! Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. 33(

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