Mechanical Morcellation- Laying the controversy to rest.

An in-depth analysis of the tissue-extraction technique of morcellation, used in gynaecological surgery.

1. Mechanical Morcellation DR RANJANA JOSHI MBBS(CMC Vellore),MD(BHU) Head of Department(OB-GYN) Tinplate Hospital Laying the controversy to rest.

2. FINANCIAL DISCLOSURE I HAVE NO FINANCIAL INTEREST IN THE SUBJECT MATTER OF THIS PRESENTATION.

3. Introduction Gynaecological surgery often employs tissue extraction techniques to remove a large Myoma or uterus through a small incision. A common extraction t echnique is Morcellation . Initially, Morcellation was performed using a Scalpel at the time of Vaginal surgery and Laparotomy. As Laparoscopic and Robotic techniques were adopted , there was the advent of Electromagnetic Morcellation that utilized rapidly rotating blades to quickly core and remove the specimen through the small ports.

4. Introduction(cont’d ) As minimally invasive surgical techniques evolved, Power M orcellation became a mainstay of gynaecologic surgery. In 2014, concerns were raised that Morcellation may disseminate tumour cells in cases in which an undiagnosed Uterine malignancy was present . This prompted action by the US FDA , resulting in new guidelines for the use of Electromagnetic Morcellation and a subsequent decrease in the use of devices .

5. MECHANICAL MORCELLATOR

6. MECHANICAL MORCELLATOR

7. TIMELINE 1993 - The First Mechanical Morcellator manufactured – Steine Morcellator 1995 - Approval of the first Laparoscopic Morcellator by US FDA. 2009 -   Vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or A bd hysterectomy(ACOG) ACOG reaffirms this statement in 2011 .

8. TIMELINE (CONTD) 2012-   R ate of unexpected Leiomyosarcoma found to be 0.09 % - 9-fold higher than the 1-in-10,000 rate typically quoted to patients preoperatively (Boston) October 2013 : Boston-based Anaesthesiologist Amy Reed undergoes MIS with power Morcellation at Brigham and Women’s Hospital. Later finds out that the mass is cancerous

9. TIMELINE (CONTD) December 2013 :  M orcellation of an occult tumour may occur in 1in 400 to 1in 1000 women who have this procedure (Robert Barbieri) January 2014 :  AAGL   announces  that it is creating a task force to examine the risks involved in Power Morcellation March 2014 :  Surgeons told to use Power Morcellators inside a surgical bag only ( B&M) April 2014 : The FDA  recommends - laparoscopic Power Morcellators NO LONGER be used for Hysterectomy or Myomectomy for uterine fibroids. 2015 : 58.7% of Gynaecologists changed their surgical practice after FDA safety communication.( Mandato et al)

10. TURNING POINT CASE OF DR . AMY REID Was diagnosed with Multiple Fibroids in 2013. Was recommended Lap Hysterectomy with Morcellation . Post operatively, Dr Reid learnt that she had a Uterine Leiomyosarcoma which may have disseminated during the Surgery.

11. DISAPPOINTING NEWS RATE OF UNEXPECTED LEIOMYOSARCOMA Seedman (2012)- 0.09% in 1091 women who underwent Morcellation ACOG Study (2014) – 1in 500 will have a postop diagnosis of Stromal Sarcoma and Leiomyosarcomas US Food and Drug Administration(2014) – found the Risk to be 1:352 – for Sarcoma 1:458 -- for Leiomyosarcoma

12. FACTS ABOUT LEIOMYOSARCOMAS Uterine Sarcomas are Rare. Comprises : < 1% of all Gynaecological tumours 7-8% of all Uterine carcinomas Most common Uterine Sarcoma – Leimyosarcoma – 43% of all Sarcomas 60% present in Stage 1 Patient has a very poor prognosis even in Early Stage Disease.

13. FACTS ABOUT LEIMYOSARCOMAS (CONTD) Increased Risk seen in : 1. Black women – 2 fold increased risk ( also have a 2 fold increased baseline risk Uterine Fibroids ) 2. Increased Age – Non Specific 3 Postmenopausal Status – Non specific 4 Tamoxifen use for > 5 years 5 Childhood Retinoblastomas

14. PRE –OP EVALUATIONOF LEIOMYOSARCOMAS 1. Endometrial Sampling – yields a pre- op diagnosis in 33% - 68 %of women with Uterine sarcomas . 2 . MRI – No specific findings- ?Ill-defined margins - Absence of Calcification – consistent 3 . PET – Too expensive / non specific PER OP SUSPICION – soft, yellow, loss of whorled appearance , absence of bulging surface when the capsule is cut.

15. ADVANTAGES OF EMM 1. Morcellation - I ntegral part of making Laparoscopic surgery possible for the removal of large uterine fibroids 2. Increases efficiency during these procedures. 3. Myospindle cells were detected in the Peritoneal cavity following Myomectomy with Morcellation (Toubia et al) But it has been proved that Myospindle cells were found even during Myomectomy without Morcellation .

16. ADVANTAGES OF MINIMALLY INVASIVE SURGERY No large abdominal laparotomy incision Faster healing and recovery from surgery Less post op pain Lower risk of surgical site infection More rapid return to normal activities.

17. DISADVANTAGES OF EMM 1 . DISSEMINATION of tumour - benign or malignant throughout the intraperitoneal cavity 2. HINDERS a proper histological examination of the uterine specimen. 3. Dissemination of the tumour can WORSEN the prognosis. 4. TRAUMA to surrounding structures – small and large Bowels, Ureter , Bladder , Diaphragm.

18. DISADVANTAGES OF EMM (CONTD) 5. ACUTE complications – PerItonitis , Intraabdominal abscesses, Intestinal Obstruction 6. CHRONIC Complications – Disseminated Fibroid tumour( seen in fibroids with abnormal karyotype- translocation between chromosome 12 & 14, and this causes Leiomyomatosis ) 7. Endometriosis 8. SEEDING of the cancer throughout the Peritoneal cavity

19. GUIDELINES FOR POWER MORCELLATION SPECIFIC GUIDELINES for the use of P ower Morcellation : Preoperative evaluation before Hysterectomy -- Cervical cytology , Endometrial biopsy and Pelvic imaging . If preoperative evaluation raises suspicion for malignancy, M orcellation clearly should be avoided . Morcellation - avoided in patients with a history of tamoxifen use, pelvic radiation, or increased genetic risk for malignancy . Surgeons should review surgical alternatives -- L aparotomy , M ini-laparotomy and C olpotomy with manual morcellation vaginally or within an endoscopic bag.

20. CONTAINED BAGS

21. CONTAINED TISSUE EXTRACTION- ABDOMINAL 1 In 2014, Einarsson et al. “Sydney in bag morcellation ” technique 2 Rimbach et al. -More-Cell-Safe. 3 Paul et al . designed isolation bag ( MorSafe ) for two-port morcellation method .

22. CONTAINED TISSUE EXTRACTION-CONTD The current body of evidence suggests that contained PM is a time efficient and feasible method in laparoscopic surgery.

23. VAGINAL APPROACH TO CONTAINED TISSUE EXTRACTION Commonly used Vaginal M orcellation techniques include bivalving , wedge resection, coring, myomectomy. Vaginal M orcellation can be performed within a containment bag to prevent tissue dissemination.

24. CONCLUSION M orcellation of the specimen in an enclosed fashion should be the preferred method Nonetheless , in patients with suspicion for occult uterine malignancy after an appropriate preoperative evaluation, M orcellation should be avoided . M inilaparotomy or vaginal retrieval in a containment bag is a feasible option

25. CONCLUSION A n advanced innovative surgical method providing an enclosed space not only for the M orcellation procedure but also for the preceding myomectomy procedure can be developed in the future. I t should be emphasized that there is currently no available method for tissue extraction that completely eliminates the risk of cellular dissemination. .

26. TAKE HOME MESSAGE Since the initial Food and Drug administration warning about Morcellation in 2014, subsequent studies do not support the FDA’s high incidence of occult uterine cancer. MIS techniques have revolutionised Gynaecology , drastically reducing the need for open procedures . To maximise patient’s safety while preserving the rapid recovery and low morbidity of laparoscopic and vaginal approaches, c urrent research continues focusing on methods of CONTAINED tissue Morcellation .

27. Thank You For Listening!