Dilapan-S Sales Training

1. Dilapan-S™ Sales Training Presented By: Date Prepared:

2. Contents Learning Objectives Dilapan-S™ Product Description Key Selling Attributes Product Use Challenges and Complications to Selling Other Selling Suggestions Summary of Learning

3. Learning Objectives You will learn: A description of Dilapan-S, including mechanism of action. Dilapan-S indications for use. Key selling attributes for Dilapan-S including competitor information. Insertion and removal techniques. Challenges & complications with selling Dilapan-S. Potential customers Guidelines for preparing to sell.

4. Purpose of This Document This document has been designed to: Provide guidance for the purpose of training sales personnel about Dilapan-S. Act as a guide only, and may have to be modified to suit your specific market needs and medical practices. Be used for sales training only and is not to be left with the customer. Assist sound marketing practice and does not guarantee success. Supplement your knowledge of your market.

5. Dilapan-S™ Product Description

6. Dilapan-S™ Description Dilapan-S is a hydrophilic polymer rod used for dilation of the cervical canal. Is a polymer and does not contain latex or any animal products. Does not contain any medicinal component that is released during use. Method of action is similar to that of seaweed dilators or Lamicel.

7. Dilapan-S™ Method of Action Dilapan-S immediately following insertion in the cervical canal draws and absorbs fluid from the cervical tissue into the polymer rod causing expansion of the rod which produces an outward radial force. While absorbing fluid from the cervix, there is a corresponding endogenous prostaglandin release1 causing collagen degradation which softens the cervix. 1The cause of this response is not clearly understood since there is no chemical or medicinal component released by Dilapan-S during use.

8. Dilapan™ – Indications for Use Ripening (softening) of the cervix prior to labor induction. Dilation of the cervix prior to termination of pregnancy. Dilation of the cervix in response to fetal demise. Gynecological uses such as coloposcopy.

9. Dilapan-S™ Key Selling Attributes

10. Key Selling Attributes Safe Dilapan-S’ unique polymer properties reduce the risk of trauma during insertion & dilation. Dilapan-S is a sterile, single use product thus reducing the risk of infection. Comfortable Dilapan-S should be moistened before insertion. Doing thus, makes Dilapan-S slippery facilitating easy, less painful insertion. Expansion of Dilapan-S in the cervical canal is gentle, predictable and results in less cramping (discomfort).

11. Key Selling Attributes Biocompatibility Dilapan-S has and continues to undergo strict test procedures to verify that it is compatible with human tissue and use. Dilapan-S has been shown to be safe to use for over 12 years without one instance of infection (when used properly). Effective Dilapan-S has been used effectively in a broad number of indications for use. There have been no adverse events regarding the use of Dilapan-S. Dilapan-S has 36 month shelf-life.

12. Dilapan-S™ Variety of Sizes: 4mm x 65mm 4mm x 55mm 3mm x 55mm Available in boxes of 25

13. Dilapan-S™

14. Dilapan-S™ Advantages The following advantages of Dilapan-S should be emphasized when selling: Man-made Synthetic without external / natural influences. Control of manufacturing process. Rigorous Quality Assurance (QA) procedures and tests. Safely used for over 12 years Decreased risk of cervical / uterine perforation over rigid, metal rods. Decrease pain Less risk of anesthesia No reports of adverse events. No drug or drug interaction Eliminates drug side effects found with prostaglandin use. Reduces risk of fetal distress.

15. Dilapan-S™ Advantages (cont’d) Sterile Achieved with gamma ray method. No concerns of residual sterilization products. Effective Use Used throughout the world in over 20 countries. CE Marked FDA approved Nintei approved Cost Effective Usually require only one Dilapan-S, whereas other osmotic dilators require multiple insertions. Eliminates time and cost of anesthesia. Reduces physician’s time with patient.

16. Dilapan-S™ Advantages (cont’d) Convenient to use Easy to insert Rapid and consistent action Same day procedure More predictable

17. Dilapan-S™ Product Use Always refer to the Instructions for Use

18. Insertion Technique Moisten Dilapan-S with sterile water, sterile saline or povidone-iodine. Present product in sterile fashion and grasp handle with long forceps. After visualizing the cervix, gradually and without undue force, insert until it traverses the external and internal os. Do not insert past the handle. The boarder of the handle should rest at the external os. Hold the Dilapan-S in place for 15 seconds to prevent spontaneous expulsion. Repeat as necessary. Place moistened gauze pads, as packing in the vagina. Always refer to the Instructions for Use

19. Dilapan-S™ Dilation The amount of dilation depends on the time in situ. The following is a provided as a guide:

20. Dilapan-S™ vs. L. japonica Greater, More Rapid Dilation One 4mm unit consistently achieves 10-11mm in as little as four hours. Expands 3 to 4 times faster than L. japonica

21. Dilapan-S™ – Removal Technique Remove packing materials (gauze) from vagina. After visualizing the cervix, grasp the handle only of the Dilapan-S with forceps and apply steady, downward traction in line with the long axis of the device. DO NOT twist. DO NOT pull on string tied to handle. The string is provided as a marker for locating the handle. Remove and dispose of all Dilapan-S after use. Always refer to the Instructions for Use

22. Dilapan-S™ – Pre-induction Cervical Ripening Dilapan-S Use as many Dilapan-S as can be comfortably inserted (4-6) in situ for at least 12 hours. Dilapan-S, 4mm x 55mm, may be the size of choice. Competition Prostaglandin formulations Dilapan-S – Advantages Dilapan-S is much less expensive than prostaglandin preparations even when the maximum number is used. Only a one time insertion of Dilapan-S is needed. Prostaglandins usually require two or more applications. Dilapan-S has no drug (no gastrointestinal side effects). Dilapan-S does not cause uterine stimulation, thus reducing the risk of fetal distress. Always refer to the Instructions for Use

23. Dilapan-S™ – Termination of Pregnancy & Fetal Demise Dilapan -S – The following is provided as a guide: Competition Laminaria japonica Rigid dilators Prostaglandin's Dilapan-S – Advantages Cost; No drug side effects; One day procedure for early gestations Always refer to the Instructions for Use

24. Dilapan-S™ Competitor Information

25. Dilapan-S™ Selling Suggestions Need to speak with physician - brief explanation and demonstration in vial of saline. Let doctors feel and see. Offer yourself and FEMA International as the product experts. Emphasize that you are available to help. Sell against competition. Know competitive information - metal rods, L. japonica, Prostaglandin's. Give enough samples to allow physician to make an informed decision. Introductory Offer / Special limited time price. Follow-up with users. Direct mail, attend medical shows, trade journals, etc.

26. Dilapan-S™ Potential Customers Physicians Midwives Clinics Out-patient clinics Pharmacists Hospitals and hospital buying groups

27. Dilapan-S™ Challenges and Complications to Selling

28. Dilapan-S™ Challenges that may be Encountered Infection - May be caused by improper or poor technique. Very rare. Uterine perforation - May occur if excess force is used during insertion. Breakage – Cause is not clearly understood. May be caused by scarring / stenosis, poor technique, excessive twisting or removed too soon. Very rare. Inadequate dilation - Usual cause is Dilapan-S was not inserted through the internal os; removed too soon; not enough Dilapan used. Retraction in uterus – Dilapan not held in place following insertion to ensure position is stabilized; insertion too far. Characterized by only string being visible at time of removal. Entrapment – Dilator cannot be removed due to inadequate swelling of gel along its length at some point. Possible causes: removal attempted too soon (<4 hours), scarring / stenosis. In all cases the Health Care Professional should refer to the Instructions for Use for an explanation of the steps needed to resolve in combination with good medical practices.

29. Dilapan-S™ Reasons for Dissatisfaction Following is a list of possible reasons that may result in dissatisfaction with Dilapan-S prior to or immediately following first use of Dilapan-S: Doctor did not follow or read Instructions for Use prior to using. Used in early gestation (under 8 weeks – not recommended). Used in stenotic cervix; scarring of cervix. Removal attempted in less than four hours. Excessive twisting during removal attempt. Improper technique used for insertion or removal.

30. Possible Complications with Dilapan-S™ Infection Very rare. There are no known incidence related directly to Dilapan-S (no reports in past 12 years). Insertion can introduce bacteria from vagina during insertion. If symptoms of infection occur, aerobic and anaerobic cultures should be obtained and appropriate antibiotics prescribed. Perforation of the uterus May occur if excess force is used during insertion. If perforation is suspected, remove Dilapan-S and observe for hemorrhage. If Dilapan-S is in peritoneal cavity, remove as soon as possible. Always refer to the Instructions for Use

31. Possible Complications with Dilapan-S™ (cont’d) Breakage Very rare. There are no confirmed incidence (no reports in past 12 years). Every attempt should be made to grasp the proximal end of the device and draw with constant force along the axis of the cervical canal. The device can be broken up into smaller pieces. Every attempt must be made to remove all fragments. The effects of retained fragments is unknown. Inadequate Dilation Usual cause is Dilapan-S was not inserted through the internal os far enough to allow for the 15-20% reduction in length during use. Always refer to the Instructions for Use

32. Possible Complications with Dilapan-S™ (cont’d) Retraction in Uterus If string only is visible, use string to gently pull Dilapan-S downward. If handle is visible, use Bozeman forceps to pull down or push into uterus. If in uterus, suction out / curette. Entrapment Dilapan-S cannot be moved in either direction. Leave device in place for longer period of time may reduce entrapment. May need to turn device in one direction, no more than 45 degrees, while pulling. May be caused by scarring at internal os, spasms of internal os, stenosis. Always refer to the Instructions for Use

33. Other Selling Suggestions Review of Literature and Text Books Time should be spent reviewing relevant literature and text books including: The Instructions for Use Cervical Ripening & Labor Induction Cervical Dilation – Techniques and Practice Cervical Dilation Using Osmotic Dilators Abortion Colposcopy Hysteroscopy Cervical Stenosis

34. Dilapan-S™ Bibliography Numerous articles have been written and published regarding Dilapan. Following is a brief listing. Copies are available upon request. Cervical Dilatation A Comparative Study of Dilapan-S and Laminaria for Preparation of the Cervix Prior to Suction Termination of Pregnancy: a Preliminary Report. Graham Robinson, Division of Pathology, Department of Clinical Laboratory Sciences, University Hospital, Queen’s Medical Center, Nottingham NG7 2UH, England. (White Paper) Prospective Comparison of Dilapan and Laminaria for Pretreatment of the Cervix in Second Trimester Induction Abortion. Paul Blumenthal, MD, MPH, Obstetrics & Gyn., 72:243, (1988). Preoperative Dilatation of the Cervix at Legal Abortion with a Synthetic, Fast Swelling Hygroscopic Tent. H. Bokstrom, N. Wiqvist, Acta Obstet. & Gyn Scand, 68 (1989). Same Day Dilapan Insertion Before Second-Trimester Dilatation and evacuation for a Fetal Anomaly or Death. Bruce Patsner, MD, The Journal of Reproductive Medicine, (1996). The Advantages of Dilapan in Second Trimester Abortions. Lise Fortier, MD; Judi Olmstead, PA; Georginna Kovacs, PA; Sheila Goodman, RN; Haifa Azawi, MD (White Paper). Laminaria versus Dilapan Osmotic Cervical Dilators for Outpatient Dilation and evacuation Abortion: Randomized Cohort Comparison of 1001 Patients. W. Hern, MD. Am J Obstet Gynecol. (1994). Mifepristone and Misoprostol versus Dilapan and sulprostone for Second Trimester Termination of Pregnancy. N. Jansen, P. Pasker-De Jong, H. Zondervan. Journal of Maternal-Fetal and Neonatal Medicine. 21:847-851 (2008). Pre-operative Gemeprost Pessaries Compared to Dilapan Hygroscopic Dilators in Primigravid First Trimester Legal Abortion. J.H. Phipps, D.R. Griffin, S. J. Ormerod. J Obstet Gynecol. (1989). Slow Cervical Dilatation in Voluntary Abortions during the First Trimester: Comparison of three Methods. M. Luerti, E. Casolati, A. Agarossi, and G. Monolo. Translated from Italian. Rivista Di Ostetricia, Ginecologia Pratica E Medicina Perinatale. (January-March 1989).

35. Dilapan-S™ Bibliography (cont’d) A New Alternative in The Hygroscopic Dilatatio of the Cervix. C. Confalonieri, MD; M. deGiambattista, MD. Translated from Italian. Rivista Di Ostetricia, Ginecologia Pratica E Medicina Perinatale. (January-March 1988). Hygroscopic Cervical Dilator (Dilapan-S) and Misoprostol Combination for the Early First Trimester Termination of Pregnancy: A Pilot Study. M. Samuel, MD, J Parsons, MD. J Fam Plann Reprod Health Care. 35(1): 45-47 (2009). Dilapan versus Prostaglandin E1 in Induction of Mid-trimester Abortion. Diaa El-Mowafi, Nabil El-Orabi, Ibtesam El-Arousi. Department of Obstetrics and Gynecology, Benha Faculty of Medicine, Egypt. 2001 (White Paper). Cervical Dilation: A Comparison of Lamicel and Dilapan. E. Wells, MD, J. Hulka, MD. Am J Ostet Gynecol. 1124-1126 (1989). Cervical Dilation Before First Trimester Surgical Abortion (<14 Weeks’ Gestation). Society of Family Planning. Contraception, 76: 139-156 (2007). Gynecological   Use of Hygroscopic Cervical Dilators in Colposcopy - F. Golsis, C. Giorgi, C.Golsis, M. Mazzari, Rivista di Ostetricia Ginecologia Practica e Medicina Perinatale, III:1, Jan-Mar. 1988. Preventing Cervical Conization by Achieving Satisfactory Colposcopy with Hygroscopic Cervical Dilators. Jefferey Stern, MD; Carol Major, MD; Linda Van Le, MD. American Journal of Obstetrics and Gynecology. (1990).

36. Dilapan-S™ Bibliography (cont’d) Synthetic Hygroscopic Cervical Dilator Use in Patients with Unsatisfactory Colposcopy. Marian L. McCord, MD; Thomas G. Stovall, MD; Robert L. Summitt, Jr., MD; Gary H. Lipscomb, MD; Kimberly W. Collins, MD; Linn H. Parsons, MD. Obstetrics and Gynecology. (Vol. 85, No. 1, January 1995). Long-term Retained Hygroscopic Cervical Dilator. T. Aeby, MD, R. Bauman, MD, N. Sato, MD. Obstet Gynecol. 94:855 (1999). Labor Induction   Randomized Trial of Dilapan and Laminaria as Cervical Ripening Agents Before Induction of Labor. P. Blumenthal, R. Ramanauskas, Obst. & Gyn, 75:365, (1990). A Comparison of Three Pre-Induction Cervical Priming Methods: Prostaglandin E2 Gel, Dilapan-S Rods and Estradiol Gel. A. Roztocil, L. Pilka, J. Jelinek, M. Koudelka and J. Miklica. Ces. Gynak., 63 (1988). Hygroscopic Cervical Dilators and Prostaglandin E2 Gel for Preinduction Cervical Ripening A Randomized, Prospective Comparison. L. Sanchez-Ramos, MD, A. Kaunitz, MD, P. Connor, MD. The Journal of Reproductive Medicine, 37:355-359 (April 1992). Preinduction Cervical Priming in Patients with Hypertension and Renal Disease by Means of Hygroscopic Rods – Dilapan. A. Rozticil, J. Jelinek, L. Pilka. 27th International Congress on Pathophysiology of Pregnancy, Manila, Philippines (November 1995). A Prospective Randomized Evaluation of a Hygroscopic Cervical Dilator, Dilapan, in the Preinduction Ripening of Patients Undergoing Induction of Labor. G. Gibson, MD, D. Russell, MD, L. Izquierdo, MD, C. Quails, Ph.D., L. Curet, MD. Am Jour Obstet Gynecol. 175 (July 1996). Cervical Ripening with Prostaglandin E2 Gel and Hygroscopic Cervical Dilators. D. Hay, M. Filshie, D. James. XXVII British Congress of Obstetrics & Gynecology (RCOG), Dublin, Ireland (1995).

37. Dilapan-S™ Bibliography (cont’d) Pre-Induction Cervical Ripening: A Randomized Comparison of Two Methods. J. Krammer, MD, M. Williams, MD, S. Sawai, MD, W. O’Brien, MD. Obstetrics & Gynecology 85:614-618 (1995). Histological   A Histological Study of the Effects of Dilapan on Human Cervix. Dr. Graham Robinson, Department of Histopathology, University Hospital, Queen’s Medical Center, Nottingham NG7 2UH, England, (1987).

38. Dilapan-S™ Summary You have learned: What Dilapan-S is and how it works effectively. Dilapan-S’ indications for use. Selling Points. Competitive information and how to overcome objections to trying Dilapan-S. Insertion and removal techniques. Possible problems with the use of Dilapan-S. Potential customers Recommendations for preparing to sell Dilapan-S.

39. Questions Thank you