Feel Whole. Do You? 1in 2. again! women may experience pelvic organ displacement (prolapse) in their lifetime 1

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1 1in 2 women may experience pelvic organ displacement (prolapse) in their lifetime 1 Do You? Feel Whole again! Your Resource Guide To Pelvic Organ Prolapse

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3 Pelvic organ Prolapse Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched, resulting in the displacement (prolapse) of the pelvic organs from their normal position.

4 Prolapse is caused by muscles and ligaments that have been weakened or damaged. The most common causes of prolapse include: 1 Pregnancy Childbirth Menopause Previous Surgery Obesity Aging Genetics

5 There are Several Types of Pelvic Organ Prolapse Bladder Prolapse (Cystocele) A cystocele is formed when the bladder bulges (prolapses) or protrudes (herniates) into the vagina. Small Bowel Prolapse (Enterocele) An enterocele occurs when the small bowel prolapses or protrudes into the vagina. Rectal Prolapse (Rectocele) A rectocele occurs when the rectum prolapses or protrudes into the vagina. Uterine Prolapse (Procidentia) A uterine prolapse occurs when the uterus prolapses or protrudes into the vagina. Vaginal Vault Prolapse A vaginal vault prolapse occurs when the upper part of the vagina falls into the vaginal canal. This sometimes occurs after a hysterectomy, causing the vagina to turn inside out.

6 Symptoms common to pelvic organ prolapse include: A bulge or lump in the vagina The vagina protruding from the body A pulling or stretching feeling in the groin area Difficult or painful sexual intercourse Vaginal pain, pressure, irritation, bleeding or spotting Urinary or fecal incontinence Difficulty with bowel movements Delayed or slow urinary stream Women may experience stress and a decreased quality of life as a result of pelvic organ prolapse (POP). Symptoms may limit daily activities and related decisions. 2,3 In addition, POP can affect work performance and can have a major impact on sexual activity. 2,3 One study found that women with prolapse endure their symptoms for years, delaying conversations with doctors because they are reluctant to discuss the subject. 4 Approximately 45-75% Approximately 45-75% of women may experience some degree of prolapse in their lifetime 1

7 Your Body Before and After Prolapse Uterus Bladder Cervix Vaginal Apex Vagina Rectum Pubic Bone Anus Typical Pelvic Anatomy Bladder Prolapse (Cystocele) A cystocele is formed when the bladder bulges or herniates into the vagina. Uterus Bladder Rectum Prolapse Bladder Prolapse Urethra Vagina

8 Rectal Prolapse (Rectocele) A rectocele is formed when the rectum bulges or herniates into the vagina. Uterus Bladder Rectum Rectal prolapse Urethra Prolapse Vagina Small Bowel Prolapse (Enterocele) A enterocele is formed when the small bowel bulges (herniates) into the vagina. Uterus Bladder Prolapse Rectum Vagina Urethra

9 Your Body After Prolapse Uterine Prolapse (Procidentia) A procidentia occurs when the uterus falls into the vagina. Uterus Prolapse Uterine Prolapse Vaginal Vault Prolapse Vaginal vault prolapse occurs when the upper portion of the vagina (the apex) descends into the vaginal canal. Bladder Prolapse Rectum Vaginal Prolapse Vagina

10 The Most Common Causes of Prolapse Include: 1 Childbirth Often the stresses and strains of childbirth (especially multiple, large, or difficult childbirth) can weaken or damage pelvic muscles and ligaments, and eventually, cause pelvic organ prolapse. Previous Surgery Surgeries, especially in the pelvic area may affect your muscles and other supportive tissue, potentially leading to pelvic organ prolapse. Hysterectomy Because important, supportive ligaments may be removed during your surgery, you may face an increased risk of pelvic organ prolapse after hysterectomy. Obesity Added weight can strain muscles in the pelvic area, and over time, this can weaken muscles, which can lead to pelvic organ prolapse. Age Because age can weaken pelvic muscles and ligaments, the risk of pelvic organ prolapse increases in fact, it doubles with each decade of life. Ethnicity Studies suggest that pelvic organ prolapse may occur more often in women of Northern European descent and less frequently in women of African-American descent. Hispanic and Asian women may have an increased risk of developing cystocele (a form of prolapse). Genetics Research suggests pelvic organ prolapse may also run in families a woman with a mother or sister who has had a prolapse may be more likely to develop prolapse. Other Women who experience repetitive straining, such as with chronic constipation, or with jobs that involve heavy lifting, may be at an increased risk for pelvic organ prolapse. In addition menopause may also be a factor in the onset of prolapse.

11 Pelvic Organ Prolapse Treatment Options Prolapse treatment options may vary depending on the type of prolapse. The treatment will depend on the severity of the condition as well as your general health, age, and desire to have children. Nonsurgical treatments for POP may include: Exercise Special exercises, called Kegel exercises, can help strengthen the pelvic floor muscles. This may be the only treatment needed in mild cases of uterine prolapse. For Kegel exercises to be effective they need to be done daily. Vaginal Pessary A pessary is a rubber or plastic device used to support the pelvic floor and maintain support of the prolapsed organ. A health care provider will fit and insert the pessary, which must be cleaned frequently and removed before sexual intercourse. There are two approaches to surgical treatment for POP: Reconstructive (surgery to restore normal anatomy) Obliterative (surgery to close the vagina completely) Reconstructive surgical options include: Vaginal colporrhaphy and apical suspensions using native tissue Sacrocolpopexy Transvaginal mesh (TVM) repair systems The goal of surgical POP treatments is to repair or correct the prolapse. Surgical options are used to help return prolapsed organs to a more normal anatomical position and to strengthen structures around the prolapsed area to maintain support.

12 Elevate TM Prolapse Repair System Typically, procedures to correct prolapse take place on an in-patient basis and are performed under general anesthesia. The Elevate TM Prolapse Repair System is intended to restore your anatomy (organs) to its natural position and strengthen the structures around your vagina to maintain support % In clinical studies, 91-96% of patients felt that their prolapse symptoms were some or a lot improved following surgery with Elevate TM. 5,6 Elevate TM is designed to : Offer a minimally invasive solution Minimize tissue trauma Restore normal anatomy with a faster recovery than open abdominal approaches Minimize pain compared to more invasive procedures Elevate is the #1 transvaginal prolapse repair system on the market 7

13 Warnings and Precautions As with most surgical procedures, potential adverse reactions may occur. Some potential adverse reactions to prolapse repair procedures include: Adhesion formation (scar tissue) Mild to severe bleeding (hematoma, perforation of vessels) Constipation Complete failure of the procedure resulting in recurrent POP Dyspareunia (pain during intercourse) De novo prolapse of an untreated compartment Fecal incontinence Foreign body (allergic) reaction to mesh implant Infection Mesh erosion Mesh extrusion Mesh migration Nerve damage Obstruction of ureter Pain/Discomfort/Irritation Perforation (or tearing) of vessels, nerves, bladder, ureter, colon, and other pelvic floor structures Urinary tract infection Vaginal contracture Voiding dysfunction Wound dehiscence (opening of the incision after surgery)

14 Questions to Ask Your Doctor Prolapse repair procedures require surgery and are not recommended for everyone. Talk to your doctor to determine the best treatment option for you. If you are ready to talk with your doctor about prolapse repair surgery, you can start with these questions: Would a prolapse repair surgery help correct my prolapse? What are the risks of prolapse repair surgery? What are the most common complications in your experience? How many procedures have you done? Tell me what results you have seen with Elevate. Tell me about the procedure and the recovery period. When can I resume sexual intercourse? How long will the repair last?

15 For more information and a list of frequently asked questions visit 1. Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007;369(9566): Kuncharapu I, Majeroni BA, Johnson DW. Pelvic organ prolapse. Am Fam Physician. 2010;81(9): Margalith I, Gillon G, D. Urinary incontinence in women under 65: quality of life, stress related to incontinence and patterns of seeking health care. Quality of life research Oct 2004 v. 13(8) pp Mouritsen L, Larsen JP. Symptoms, bother and POPQ in women referred with pelvic organ prolapse. Int Urogynecol J v. 14 p Lukban JC, VanDrie D, Rovers JP, Moore RD, Nguyen JNK, Lange R. Long Term Results of Elevate Apical and Posterior for Vaginal Wall Prolapse Repair. J Minimally Invas Gyn Nov 2011: Stanford E, Moore R, Rovers JP, Lukban J, Bataller E, Sutherland S. Elevate anterior/apical: safety and efficacy in surgical treatment of pelvic organ prolapse. Neurourol Urodynamics (6). 7. IMS Health - Hospital Supply Index - Q

16 Elevate TM is a registered of American Medical Systems Europe B.V American Medical Systems TM. All Rights Reserved. Amsterdam, NL-1101 CH AMSUK/PRO (11/2012) For European Use Only