Patient Name: _ Date: _

New Jersey Urologic Institute Dr Betsy Greenleaf DO, FACOOG Pelvic Medicine and Reconstructive Surgery 10Industrial Way East, Suite 101, Eatontown, New Jersey 07724 732-963-9091 Fax: 732-963-9092 Findings: _

Post Operative Instructions (Vaginal Reconstruction/Sling Urethropexy)

1. Activity: May do as much as you feel up to. Your body will let you know when you are doing too much. Don't push yourself, however. Walking is ok and encouraged. If you sit too long you will become stiff and it will make it more difficult to move. Lying around can promote the formation of blood clots that can be life threatening. It is therefore important to move around. If you don't feel like walking, at least move your legs around in bed from time to time. Stairs are ok, just be careful of standing up too quickly and becoming light headed. Sitting still can also increase your risk of pneumonia. In addition to moving around, practice taking deep breaths ( 10 times each every hour or so) to keep your lungs properly aerated. Limitations: Avoid lifting or pushing/pulling any objects heavier than 1Olbs for at least 3 months. For patients with pelvic hernia or prolapse repairs it is recommended not to lift objects heavier than 25 Ibs for life. This may seem unrealistic. Try to put off lifting as long as possible. If you must lift, do not hold your breathe. Blow out as you lift to decrease abdominal and pelvic pressure. Also be aware that if you choose to lift objects heavier than recommended you risk forming another hernia 2. Bathing: You may shower the day after surgery. Limitations: Do not submerse until cleared by your doctor (on average 6-8 weeks) No baths, Jacuzzi, swimming ... .However, may do sitz baths ( purchase from a pharmacy). Sitz bath instructions: Place sitz basin on toilet. Add 2 tablespoons of Epson salt in warm water. Fill sitz bath and sit in for no more than 20 minutes at a time. Repeat as necessary for relief. Be sure to clean sitz bath with disinfectant between uses Epsom Bath Instructions: You may also use the bathtub to do an epsom bath for swelling relief. First take shower to rinse of skin bacteria. Make sure the tub is then disinfected with cleaner. Fill the bath with warm water and 2 cups of Epsom salt. Do no soak for longer than 20 minutes. Repeat as necessary for relief of discomfort and swelling.

Page 1 : 4 3. Driving: You may drive when off pain medications (average 2-4 weeks) 4. Diet: You may return to regular diet as soon as possible. No restrictions 5. Medications: Take all medicine prescribed as directed. Prescribed medications will be checked below.

__Percocet one to two pills every 4-6 hours as needed for severe pain ( may cause nausea and constipation) ____ every 4-6 hours as needed for severe pain. (may cause nausea and constipation) ___Nucynta 50 mg one pill every 4-6 hours as needed for severe pain ___ Sprix 15.75 mg one spray in nostril every 6 hours for pain and to keep down inflammation. Do not use past 5 days. ___Motrin 600mg every 6 hours for pain and to keep down inflammation. Take with food. (may cause stomach upset) ___Vimovo 375/20 mg one pill twice daily for pain and to keep down inflammation.

_XX_ Miralax one tablespoon in 8 oz of liquid daily to prevent constipation. Over the counter

___Premarin cream Apply one inch of cream to vulva with finger three times a week. VERY IMPORTANT: aids in healing.

__Estrace Cream Apply one inch of cream to vulva with finger three times a week. VERY IMPORTANT: aids in healing.

__You have an Estring hormone ring in place. This is a hormone ring that will aid with healing. It is good for 3 months and then needs to be removed. If falls out, wash it with soap and water either replace in the vagina or notify the office to schedule an appointment to have it replaced.

__Macrobid one pill twice daily ( preferably every 12 hours) if you go home with catheter.

___ Bactrim one pill twice daily ( preferably every 12 hours) if you go home with catheter.

__ Pyridium one pill every 8 hours as needed for bladder irritation. May need if you go home with a catheter. Turns urine orange.

Page 2: 4 __Urelle or Prosed OS one pill every 6 hours as needed for bladder irritation. May need if you go home with a catheter. Turns urine blue. ___ Other

6. Urinating: Sometimes after surgery you are too swollen to urinate and will need to go home with a catheter until some of the swelling diminishes. If you go home with a catheter you will need to follow up in office in days/weeks for removal. Call to schedule appointment. Make sure you take antibiotics while catheter in place (marked above) Difficulty urinating: If you go home without a catheter and have difficulty urinating, it is important to try and relax. Let the bladder do the pushing. Often if you try bearing down to push the urine out you will not be able to urinate. You may also try getting into the shower to pee. The warm water may stimulate you to urinate. You can also attempt to push on your lower abdomen with you hand to attempt to start the flow. If you are still unable to urinate you may need to come to the office for the placement of a catheter or if the office is closed, go to the nearest emergency room. Leaking: It is not unusual to leak after surgery. Sometimes you are too swollen for the urethra to close all the way, or sometimes the bladder is irritated after surgery and will spasm expelling urine. This is not unusual for 4-8 weeks after surgery. If it continues past 12 weeks your doctor will look into further causes of your leaking. 7. Bleeding: It is not unusual for the vagina to bleed and ooze after surgery. Sometimes the bleeding will pick up a week or two after surgery. This is commonly caused by the body dissolving any blood clots that formed at the surgery site. This dissolved blood will then leak through your incisions. It may be seen as a gush of fluid after standing or walking around. It is not unusually for this vaginal discharge to have an odor. If it is itching or burning, please notify your doctor. Change maxi pads every 2-4 hours to prevent infection. Pads hold in bacteria thus it is important to keep clean. If the bleeding is continuous and you are soaking through more than a maxi pad an hour for two hours, notify your doctor. Also call if this bleeding is associated with shortness of breath, light headedness, fainting ...... 8. Constipation: DO NOT GET CONSTIPATED. This is easier said than done. Surgery alone can cause constipation as can pain medications. You can avoid constipation by increasing your activity. The more you walk the more you will get your bowels to work properly. Stick with a high fiber (unless otherwise instructed by your doctor) diet and increase your fluid intake preferably water ( 64-96 oz a day). You may also use over the counter constipation products and combine

Page 3 : 4 them if necessary. Just make sure to drink a lot of lluids. You may try Milk of Magnesia, Maalox, Dulcolax suppositories, Glycerin Suppositories, Metamucil, Fleets phosphasoda, or enemas. Stay away from Senekot or "senna" containing products: your body can become dependent on these. 9. Fever: A fever is any temperature above 100.4 F. Fever can be a normal reaction of your body to the stress of surgery. However, notify your doctor for temperatures above 101 F. 10. If you are diabetic: The stress of surgery may cause your sugars to increase. Pay close attention to your sugars and notify your endocrinologist or primary doctor if your sugars are running high. High sugars can prevent healing and can increase your risk of infection 11. Pelvic Rest: Nothing in the vagina until your doctor clears you. On average this is for 4-8 weeks. This means no vaginal sex, no tampons, no douching...... 00 not receive oral sex until cleared by doctor. Other sexual activities may be engaged in as tolerated. Feel free to contact your doctor with any questions. 12.Wound care: Other than using a hormone cream or ring vaginally to aid in healing there is nothing that you need to put on your incisions. Just keep incision sites clean and dry. Clean with mild soap and water. You do not need Neosporin, Bactroban, Bacitracin, Vitamin E....or any other topical ointments. These products can actually prevent healing initially by getting into the incision and preventing it from coming together. Vitamin E can be used on external incisions after 2-4 weeks, but check with doctor before using. 13.Bruising: It is not unusual to get bruising after surgery. You may apply heat to these areas 48 hours after surgery to help your body absorb the bruising. 14.Air under skin if you had laparoscopic surgery: You can also get some leakage of air under your skin from the laparoscopic portion of the procedure. Your tissue may feel like "rice Krispies" from these air bubbles. This air will be absorbed over a period of 3-5 days. 15. Follow up appointments: Call office to make follow up appointment. You will need to be seen: __ 2-4 weeks after surgery

__ 6-8 weeks after surgery

__6 months after surgery

__12 months after surgery

__Yearly after surgery

_XX_ If you have any problems or concerns

Page 4: 4 8/22113 Take the Floor: Types of Surgery

Types of Surgery

Apical Suspensions

The most important aspect of a prolapse repair (when maintaining sexual function is desired) is restoration of the support of the top of the vagina which is also called the vaginal apex or vault. Common procedures that do this are:

Abdominal Sacral Colpopexy (ASC) - The ASC is performed through an abdominal incision (about 3-4 inches long), laparoscopically (through 4 half inch incisions) or roboticaly. In this procedure straps of graft material are used to reinforce the front and back walls of the vagina. These straps are then attached to a strong ligament o'Rrlying the sacrum. The end result is that the vagina is suspended O'Rr the pelvic muscles to the back-bone. The mesh graft straps replace the original natural support provided by the uterosacral ligaments.

Uterosacral or Sacrospinous Ligament Fixation - When a vaginal incision is preferred, the top of the vagina is most often suspended to a woman's own uterosacral ligament or the sacrospinous ligaments. Traditionally these procedures did not use graft material. Recently, more surgeons are adding graft reinforcement to the natural ligament suspensions in an effort to impro'R the durability of the prolapse repair when surgeons find the vaginal wall to be weak. Research studies are being conducted to determine if this desired benefit will result in superior outcomes.

Anterior Vaginal Prolapse Repair

A Cystocele or bulge of the front wall of the vagina usually results in loss of support to the bladder that rests upon this part of the vagina. The goal of a cystocele repair is to elevate the anterior vaginal wall back into the body and support the bladder. This can be done either vaginally called anterior colporrhaphy or through an abdominal approach at the time of a sacral colpopexy.

Anterior colporrhaphy is a commonly performed repair of a cystocele. In an anterior colporrhaphy, an incision is made in the front wall of the vagina. The vaginal skin is separated from the bladder wall behind it. The weak or frayed edges of the deep vaginal wall are found and the strong tissue next to edges are sutured to each other lifting the bladder and recreating the strong "wall" underneath it. The vaginal incision is then closed with dissolving stitches. Unfortunately, this part of the pelvic floor is subjected to significant pressure with each cough or when picking up heavy things. As many as one third of women will de\€lop recurrent anterior prolapse after an anterior colporrhaphay. To reduce this recurrence of prolapse, a surgeon may chose to place a "patch" of graft material O'Rr the repair line to reinforce the repair. Studies are in progress to help us learn whether or not using grafts provides superior results when compared to traditional surgeries. The studies will also compare the risks of the two types of procedures and who benefits most from the mesh reinforcements.

Posterior Vaginal Prolapse Repair

A rectocele or bulge of the back wall of the vagina is most often repaired by a vaginal procedure called posterior colporrhaphy. If the muscles at the opening of the vagina ha'R been stretched or separated during childbirth, the repair may include a perineorrhaphy. A rectocele may also be fixed abdominally at the time of a sacral colpopexy.

Posterior Colporrhaphy - Colpo- means "vagina" and -rhaphy means "repair of." Posterior colporrhaphy is a procedure that repairs the rectal bulge protruding through the back wall of the vagina. During the colporrhaphy procedure, an incision is made in the back wall of the vagina. The vaginal skin is separated from the rectal wall underneath. The weak or frayed edges of the deep vaginal wall tissue are identified. The strong tissue next to edges are sutured to each other recreating the strong "wall" between the rectum and the vagina. The vaginal incision is then closed. At times, a surgeon may chose to place a "patch" of graft material o\€r the repair line to reinforce the repair. Studies are ongoing to help understand the role of these graft materials in rectocele repair. Your surgeon will most likely close the incision with self-dissolving stitches.

Perineorrhaphy - Surgical reconstruction of the muscles of the perineum, the area between the vagina and the rectum. This procedure invol\€s reattaching a number of small muscles that normally connect in this area. Obliterative Procedures

For those women who do not need to maintain sexual function, an obliterati\€ procedure may be the quickest and

WMV.l.Oicesforpfd.org/p/cm'ld/fid= 135 1/2 8122113 Take the Floor: Types of Surgery least risky method to correct prolapse. Obliterative operations correct prolapse by narrowing and shortening the vagina. These procedures support the pelvic organs with the patients own pelvic muscles in such a way as to make the vagina too small to accommodate a penis for sexual intercourse. The skin overlying the vaginal bulge is removed, and the front and back walls of the vagina are sewn to each other. A woman who has undergone this surgery will look the same on the outside of her genital area and she will be able to have bowel movements and urinate normally. Her ability to have an orgas m with clitoral stimulation is similar to before her surgery.

There are two main types of obliterative surgery:

• partial (colpocleisis) • complete (colpectomy)

Both are very effective and durable in correcting prolapse. Prior surgeries often influence which procedure is offered to women. The benefit of obliterative surgery is that it is very durable, does not involve the risks of graft materials, tends to be less invas ive and therefore is associated with a quicker recovery.

Sources

Original publication date: May, 2008; Updated, February 2012.

WNN.\Qicesforpfd.org/plcm'ldlfid~ 135 212 Safety Communication~ > FDA Safety Communication: UPDATE on Serious Complicati... Page 1 ot 4

Home Medical Devices Medical Device Safety Safety Communications Medical Devices FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse Date Issued: July 13, 2011 Audience: • Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence • Health care providers involved In the care of patients with surgical mesh implanted to repair pelvIc organ prolapse and/or stress urinary incontinence • Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine Device: Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue, It is made from porous absorbable or non­ absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, Background: Pelvic Organ Prolapse Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs In place become weak or stretched, Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) Into the vagina and sometimes prolapse past the vaginal opening, More than one pelvic organ can prolapse at the same time, Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel. Stress Urinary Incontinence Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise. Purpose: On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on senous complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI. Based on an updated analysis of adverse events reported to the FDA and complications described In the sCientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern, The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare, This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and It may expose patients to greater risk. This Safety Communication prOVides updated recommendations for health care providers and patients and updates the FDA's activities involVing surgical mesh for the transvaginal repair of POP, The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date. For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,l Summary of Problem and Scope: In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 - 2007) was "over 1,000." Since then, from Jan. 01, 2008 through Dec, 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it IS common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high. From 2008 - 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh eroSion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain dunng sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems, Many of these complications require additional intervention, including medical or surgical treatment and hospitalization. In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 - 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair, The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date, In particular, the literature review revealed that: • Mesh used in transvaginal POP repair Introduces risks not present in traditional non-mesh surgery for POP repair. • Mesh placed abdominally for POP repair appears to result In lower rates of mesh complications compared to transvaginal POP surgery with mesh. • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) With mesh prOVides any added benefit compared to traditional surgery without mesh, • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, thiS anatomic benefit may not result in better symptomatic results, The FDA's literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women, In some cases, even multiple surgeries will not resolve the complication. Mesh contraction (shrinkage) is a previously Unidentified risk of transvaginal POP repair with mesh that has been reported in the published

http://www.fda.govlMedicalDevices/Safetv/AlertsandNotices/ucm262435.htm 7/2/2013 Safety Conununications > FDA Safety Communication: UPDAIE on Serious CompJicati... Page 2 of 4

scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain. Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual Intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion. The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh. Recommendations for Health Care Providers: As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should: • Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh. • Be vigilant for potential adverse events from the mesh, especially erosion and infection. • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations. • Inform patients that Implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that mayor may not correct the complication. • Inform patients about the potential for serious complications and their effect on quality of life, inclUding pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh. • Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available. In addition, the FDA also recommends that health care providers: • 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 and benefits of surgery with mesh versus all surgical and non-surgical alternatives. • Consider these factors before placing surgical mesh: a Surgical mesh is a permanent implant that may make future surgical repair more challenging. o A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications. a 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 paill. a Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh. • Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvagillal surgery with mesh. • Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used. • Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.

Recommendations for Patients: Before Surgery Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications. Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh. In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used: • Are you planning to use mesh in my surgery? • Why do you think I am a good candidate for surgical mesh? • Why is surgical mesh being chosen for my repair? • What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options? • What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh? • Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall? • If surgical mesh IS to be used, how often have you implanted this particular product? What results have your other patients had with this product? • What can I expect to feel after surgery and for how long? • Which specific side effects should I report to you after the surgery? • What if the mesh surgery doesn't correct my problem? • If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications? • If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences? • If a surgical mesh is to be used, is there patient information that comes With the product, and can I have a copy? After Surgery • Contillue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not haVing complications or symptoms. • Notify your health care provider if you have complications or symptoms, IIlciuding persistent vaginal bleeding or discharge, pelvic or grolll pain or pain with sex, that last after your follow-up appointment. • Let your health care prOVider know you have surgical mesh, espeCially if you plan to have another surgery or other medical procedures. • Talk to your health care prOVider about any questions you may have.

http://www.fda.gov/MedicalDevices/Safety/AJertsandNotices/ucm262435.htm 7/2/2013 Satety CommuDlcations > FDA Satety CommunicatlOn: UPDATE on Serious Complicati... Page 3 of 4

If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit. FDA Activities: The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will: • Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI. • Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future. • Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available. Reporting Problems to the FDA: Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements2 should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations3 To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available: • Manufacturer's name • Product name (brand name) • Catalog number • Lot number • Size • Date of implant • Date of explant (if mesh was removed) • Details of the adverse event and medical and/or surgical interventions (if required) • Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI) • Surgical approach: (e.g., vaginal, abdominal, laparoscopic) • Reason for mesh Implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI) • Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment Contact Information: If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at [email protected], 800-638-2041 or 301-796-7100. This document reflects the FDA's current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Additional Information

• Urogynecologic Surgical Mesh Implants4 • Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011) (PDF - 243KB)5 • Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks6 • Federal Register Notice: Urogynecologic Surgical Mesh? • Federal Register Notice Amendment: Urogynecologic Surgical Mesh8

Page Last Updated: 06/18/2013 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Email FDA

For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local OffiCials Consumers Industry Health Professionals FDA Archive

~ U.s. DepartJ'l.lem of Health &. Human 5ervice-s

Links on this page: 1. / downloads/Medical Devices/Safety/ Alertsand Notices/UCM2627 60 .pdf 2. /M edlcal Devices/DeviceRegulationa ndGuidance/PostmarketRequi rements/Reporti ngAdverseEvents/ucm20 OS7 37. htm 3. /M edi ca IDevices/DeviceRegulationandGu ida nce/PostmarketRequ ire ments/ReportingAdverseEvents/ucm200 57 37. htm

4. /Med ica IDevlces/Prod uctsandMedicaIProcedu res/1m plantsandProsthetics/UroGynSurgica IMesh/defauIt. htm

http://www.fda.govlMedicalDevices/Safety/AlertsandNotices/ucm262435.htm 7/2/2013 8/22113 Take the Floor: Prel.€nting Pel\ic Organ Prolapse

Prevention

Because vaginal and uterine prolapse have several different causes, there is no single way to prevent these problems. Currently, a woman cannot change her genetic risk profile which influences the strength of her connective tissue. Women can make lifestyle choices that can influence risk factors that are modifiable. In general, avoiding increased pressure inside the abdomen will diminish pressure placed upon the pelvic floor is wise.

This can be done by:

• Maintaining a normal weight or losing weight if overweight. Overweight women are at a significantly increased risk of developing prolapse. • Avoiding constipation and chronic straining during bowel movement, which increase a woman's chance of developing prolapse, especially a rectocele. A diet with plenty of fiber and fluids, as well as regular exercise is important for maintaining regular bowel function. If constipation persists despite these measures, further evaluation and treatment is recommended. • Seeking medical attention to evaluate and treat a chronic cough which increases abdominal and pelvic pressure. • Avoiding heavy lifting and learn how to lift safely by using leg and arm muscles as much as possible. • Not smoking or kicking the habit! • Avoiding repetitive strenuous activities. • Learning and performing pelvic floor muscle exercises (Kegels) regularly to improve the strength of the pelvic floor and limit the likelihood of developing prolapse. Once prolapse has developed, pelvic floor exercises will not correct the prolapse, but they may limit the development of worsening prolapse and may diminish some of the symptoms.

There has been considerable discussion about whether a cesarean delivery (C-section) might reduce the chance of developing prolapse later in the life. Operative vaginal deliveries (forceps or vacuum deliveries) may increase the risk of pelvic floor injury and increase woman's risk of developing prolapse. Route of delivery is very important and a complicated topic, which one should address with their obstetrical provider. It is clear that being pregnant alone, regardless of the type of delivery, contributes to the development of pelvic floor disorders. However, it is important to remember that there are women who have never been pregnant who leak urine and stool or have prolapse - and women who have delivered many times who do not. There is no clear answer to this question at this time.

When considering your treatment options it is best to work with your urogynecologist to make a plan that works best for you. A lot depends on your individual problems, and more depends on your preferences. A woman should seek treatment whenever her symptoms have a negative impact on her life - you don't have to wait until your symptoms are 'really bad'. Prolapse can worsen one's quality of life and vaginal and uterine prolapse, while common, is not a normal result of childbirth and aging. You do not have to 'learn to live with it'. Seeking medical help does not mean that you have to have surgery right away. Some women start with more conservative treatment like physical therapy, and go on to surgery only if their symptoms from prolapse are not under control.

www.VJicesforpfd.org/p/cmlld/fid=25 1/1 Betsy A.B. Greenleaf DO, FACOOG, Specializing in Female Pelvic Medicine and Reconstructive Surgery New Jersey Urologic Institute, 10 Industrial Way East, Eatontown, NJ 07724732-963-9091

Pelvic Prolapse options:

Options:

I. Do nothing but conservative therapy a. Drink A LOT of water. Drink enough that your urine is clear and urinating at least 8 times a day. b. Cranberry supplements of 802 of Cranberry Juice a day ( however acidity may aggravate bladder symptoms) 2. Low Dose Preventative Antibiotic a. Risks include you can still get an infection, side effects, allergies, bacterial resistance 3. Pessary: Non surgical. Support device that can be worn in vagina to hold pelvic floor up. 4. Surgery: a. Open incision through abdomen: i. See same as laparoscopy II. Surgery takes approximately 1-2 hours 111. Can be a longer hospital stay: which can increase risk of picking up an infection from the hospital. IV. Compared to other procedure: higher risk of hernia development later on, higher risk of incision infection, b. Laparoscopically through abdomen: Hysterectomy and Sacral Colpopexy 1. Overnight in hospital II. Remove uterus and wrapping a piece of Y shaped mesh around vagina and attach tail to tail bone 111. Risk is up to 6 hours of surgery, overnight in hospital. Increased immediate risks of surgery near bowel, and major blood vessels IV. Advantages: Right now the studies show this has better long term success rates c. Vaginally: does not have to be combined with a hysterectomy: Surgical length of surgery approximately 2-4 hours. Same day surgery. i. Stitches only: Has 60% lifetime risk of recurring 11. Biologic Graft I. Processed pig, cow or cadaver skin that is implanted 2. Better longevity than stitches but not as good as synthetic mesh 3. Advantages: softer material so less risk of eroding or pain with intercourse 4. Disadvantage: Your body process the material and breaks it down 111. Synthetic Mesh 1. Advantages: Holds up the best of the vaginal approaches over time but we do not have long term studies on how successful it is over time 2. Disadvantages: risk of erosion, and risk of permanent pain if mesh rubs on nerve. 8/22113 Take the Floor: Mesh Information for Patients

. Mesh Information for Patients with Pelvic Floor Disorders

On July 13, 2011, the FDA issued a safety communication and update, intending to inform patients and health care providers that "serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare."

Pelvic floor disorders (PFDs) include leakage of urine, pelvic organ prolapse and bowel problems. Surgical mesh is a synthetic material that has been used in other kinds of hernia repairs as well as in surgical treatment of pelvic floor disorders. Surgical mesh is used to treat pelvic organ prolapse (POP), when the bladder vagina or uterus, or rectum "drops," and stress incontinence (SUI), leakage of urine with coughing, sneezing, or physical exercise due to weak ligaments and weak pelvic muscles.

For POP, surgical mesh can be placed both abdominally and vaginally. Mesh is placed abdominally to repair POP as part of an operation called a "sacral colpopexy." This operation lifts the vagina to the tailbone often using a piece of mesh. This procedure can be performed through an open incision in the belly or through multiple tiny scars using a robotic or camera (Iaparoscopic) technique. Mesh placed vaginally is done through incisions in the vaginal walls. Mesh placed to treat POP can be individually tailored or can come as part of a "mesh kit" procedure. Mesh used to treat stress urinary incontinence is placed under the urethra (the tube that empties urine from the bladder). This operation is called a mid-urethral sling.

The American Urogynecologic Society (AUGS), a physician-based organization dedicated to research, education and sharing of best practices in Female Pelvic Medicine and Reconstructive Surgery that results in improved care for women, presented information to an FDA advisory panel in September 2011 and reiterates these same points to patients who have undergone treatment using mesh or may be candidates for treatment.

There are different types of mesh for different purposes that have different outcomes. There is not enough supporting evidence to justify taking mesh off the market. There are differences in the uses and outcomes related to synthetic mesh used to treat stress urinary incontinence and mesh used for transvaginal or abdominal repair of pelvic organ prolapse. Synthetic mesh in the form of mid-urethral slings is used to treat stress urinary incontinence. This is the standard of care and research shows that they are safe and effective.

Mesh may be appropriate for repair of pelvic organ prolapse in some cases.AUGS does not support the routine use of transvaginal mesh for the repair of pelvic organ prolapse, but there maybe particular circumstances when the placement of transvaginal mesh is beneficial and appropriate. Placement of transvaginal mesh for pelvic organ prolapse should be used cautiously by experienced surgeons with extensive training in pelvic surgery.

It is important for patients to be informed about all treatment options for pelvic organ prolapse are pluses and minuses of each. There should be discussion between a doctor and a patient that identifies risks, benefits and possible adverse outcomes of all available treatment options. You should be informed about non-surgical treatment options, surgical repairs that use your own tissues, and abdominal repairs and transvaginal mesh repairs.

Additional information is required to make recommendations about mesh that is rooted in research. AUGS recommends research trials to get more information for transvaginal mesh for pelvic organ prolapse. AUGS supports the FDA's call for better data upon to determine whether or not mesh devices are safe and effective.

What you can do now - talk with your doctor:

1. Let you doctor know about any problems you had in the past healing from mesh surgery or rejecting certain material. If you have been treated with mesh and are not experiencing any symptoms or side effects (recurring prolapse/incontinence, pelvic pain, etc.), you do not need to have the mesh removed. 2. If you are considering surgery for SUI or POP, ask your doctor what are all the options available for your particular case and what are the pros and cons of each. 3. If your doctor is recommending using transvaginal mesh, ask why he or she is recommending using mesh in your case versus using your own tissues for the repair. 4. Ask your doctor about his/her experience using mesh and handling complications associated with mesh placement. Find a specialist online. 5. Ask your doctor what to expect after surgery, for how long, what side effects to look out for and if there are any

wNw.\Qicesforpfd.org/plcm'ldlfid=87 1/2 8122113 Take the Floor. Mesh Information for Patients restrictions after surgery. 6. Read FAQs on SUI Slings.

You can report any problems related to mesh to the FDA's MedWatch Adverse Reporting program.

WMN.\Oicesforpfd.org/p/crnlldlfid=87 212 Name: ------

Dr Betsy A.B. Greenleaf DO, FACOOG

Prolapse Surgery Risks: % Nothing in life or medicine is 100 . Risks of surgery include but are not limited to: bleeding, bruising, infection, medication complications, anesthesia complications, allergic reactions, injury to surrounding tissues, organs, nerves, bowel, bladder, blood vessels, bone.....There is a risk that you could re-herniate. This commonly happens on the opposite side of the initial surgery or in areas where mesh has not been placed. Those with a history of re-herniation, have an increased risk of herniating again in the future. There is a risk of urinary incontinence or urinary retention. If this continues past 12 weeks after surgery, this may require additional procedures. If there is a bladder/urethral injury or perforation at the time of surgery, you will be asked to have a catheter in place for 2 weeks. Most times the bladder/urethra heals on its own without additional intervention. Bowel injuries will be examined for and repaired at the time of surgery. They require that nothing be placed in the rectum ( i.e. enemas, suppositories) and avoidance of constipation. Injuries to these area may prevent the placement of mesh. Constipation is a complication of surgery. There is a risk of graft exposure or erosion. Exposure occurs secondarily to the way some people heal. The incision line can retract as it heals exposing the graft below. Graft erosion occurs when the vaginal tissue is thin and the graft wears through the vaginal tissue. This is often treated with a hormone cream to thicken the vaginal tissue. Sometimes the graft needs to be trimmed in the office, rarely this may require a repeat surgery in which the vaginal tissue is loosened over the graft and then re-closed. Having a history of a graft erosion/exposure puts you at increased risk of developing it again. Graft erosions can be an important medical concern if the mesh wears into any organs. Graft erosions may also be related to infection, that may require additional therapy. Fistulas can develop with any pelvic surgery. Fistulas are connections between organs such as a hole between the bladder and vagina or rectum and vagina. These may require additional surgery to correct.

Patient Initials: ----- Date: ------Name: ------

There is a risk of pain after surgery. This pain may be temporary or permanent. It is theorized that pain is from nerves that are pinched by scar tissue or by the mesh. This can be treated with steroid injections, nerve blocks, and rarely additional surgery. Nerve blocks dissolve the irritated nerve and there can be a risk of numbness, and loss or altered sensation. Additional surgery mayor may not relieve the source of pain. There is a risk that additional surgery can cause more scar tissue. There is a risk of back or leg nerve irritation or damage. Your legs are positioned prior to surgery in the stirrups, to assure comfort. However, from being in the stirrups for an extended period of time this can cause back muscle spasms, leg and hips spasms, and nerve stretch injuries with disturbance in gait (walking) and sensation. The majority of times these complications are temporary, but can be permanent. Any surgery can put you at risk of developing life threatening blood clots that can go to your brain causing stroke, heart causing a heart attack, or to your lungs. Massage boots are worn during your procedure to prevent the risk of developing blood clots in your legs. After surgery the more you move around, this too will aid in the prevention of these blood clots. Pneumonia can occur from not taking deep enough breaths. After surgery, you might splint yourself from the pain by taking shallow breaths. It is imperative to practice deep breathing to prevent developing pneumonia. Antibiotics are administered at the time of surgery to prevent common surgical infections, however, there are always bacteria that are not affected by these antibiotics. Antibiotics can also kill off the good bacteria in our bodies and lead to diarrhea or yeast infections. It is suggested that you eat a yogurt containing live cultures, or supplements containing lactobacillus acidophilus such as FloraQ. Bladder irritation can occur as a result of surgery and/ or a side effect of the catheter. Bladder infections are also possible. Sexual dysfunctions can be a complication of gynecologic surgery and can include but are not limited to altered/decreased sensation, decrease libido, decreased or inability to orgasm, pain with intercourse....Other generalized risks included extended hospitalization, intensive care treatment, coma, severe disability, and death.

Patient Initials:----- Date: ------Name:------

The above has been explained to me. I am aware of the risks of surgery. I do not have any additional questions or concerns at this time. I have been informed that ifI have additional questions and concerns I am to contact the office and my physician to discuss these concerns

Patient! Representative Signature Date

Witness Date

Doctor's Signature Date

Patient Initials:------Date: ------,--­ PROLAPSE TREATMENT OPTIONS Vaginal Repair with Vaginal Repair with Robotic or Laparoscopic Open Abdominal Prolapse Vaginal Obliteration Procedure Observation Pessary Vaginal Site Specific Repai r Biologic Graft Synthetic Mesh Prolapse Repair Repair Surgery Colporraphy, or Colporraphy, or Colporraphy, or Colpopexy, or Cystocele! Colpopexy, or Cystocele! Colpopexy, or Cystocele! Medical Procedure name Observation Pessary Rectocele Repair Rectocele Repair Rectocele Repair Sacral Colpopexy Sacral Colpopexy Colpocleisis Large incision usually bikini cut but can be up Small incisions located and down in middle of Vaginal incision with repai r Vaginal incision with repai r upper abdomen. Surgery abdomen. Surgery Fit vagina for a silicone of damaged tissue and re- of damaged tissue and re­ performed through performed through support that can hold up Vaginal incision with repai r enforcement with a enforcement with a abdomen. Attachment of abdomen. Attachment of Sewing shut of the vagina prolapse through the of damaged tissue with biologic graft ( pig, cow, or synthetic polypropylene synthetic mesh to internal synthetic mesh to internal so that no organs (an Procedure Information No intervention vagina stitches alone human tissue) hernia mesh vagina and tailbone vagina and tailbone prolapse cystoscopy: look into cystoscopy: look into cystoscopy: look into cystoscopy: look into cystoscopy: look into cystoscopy: look into bladder with scope bladder with scope bladder with scope bladder with scope bladder with scope bladder with scope Additional Testing Urodynamics: test bladder Urodynamics: test bladder Urodynamics: test bladder Urodynamics: test bladder Urodynamics: test bladder Urodynamics: test bladder Recommended Possibly Possibly function (unction function function function function Estimated length of Procedure NA lOminutes 2-3 hours 2-3 hours 1.5-3 hours 2-6 hours 1-2 hours 45 minutes-l.5 hrs Need for Hysterectomy NA NA No No No Preferred Preferred No heavy discharge, vaginal discomfort, vaginal Specific Risks: All ulcerations, difficulty or Surgical risks ( paper work procedures have risk. This discomfort with placing or provided) , Risk of Surgical risks ( paper work Surgical risks ( paper work Surgical risks (paper work Surgical risks I paperwork is not an all inclusive list. discomfort of prolapse and removing, depending on Surgical risks I paper work recurrence from provided). Risk of Mesh provided) higher provided) higher provided). No longer able This is a generalize risk of recurrent bladder size and shape may not be provided) + 60% lifetime absorption of graft Erosion, Slightly higher risk immediate risk of damage immediate risk of damage to have internal sexual summary infections able to have intercourse risk of recurrence material of pain with intercourse to major organs or bowels to major organs or bowels activity Major Procedure NA No Yes Yes Yes Yes Yes Yes General, sedation, or General, sedation} or General, sedation, or General, sedation, or Type of Anesthesia none none spinal spinal spinal General General or spinal spinal General, sedation, or Same Day Surgery ( out Same Day Surgery ( out General, sedation, or 11, ",I Timp in Innnp ,nno n, , - General, sedation, or Recovery time none none spinal 8 weeks 8 weeks 8weeks 8 weeks 8 weeks Lifelime Avoidance of General, sedation, or lifting or straining Yes Yes spinal Yes Yes Yes Yes Yes Risk of Recurrence Yes Yes Yes Yes Yes Yes Yes Yes Risk of Product Erosion NA Yes - Yes Yes Yes Yes Yes No Possibility of Continued" Urinary Dysfunction Yes Yes Yes Yes Yes Yes Yes Yes

long Term Studies show long Term Studies show No abdominal scars, Less bener long term success better long term success risk of damage to major rates, Less risks of erosion, rates, less risks of erosion, organs or blood vessels. and less risks of pain with and less risks of pain with No abdominal scars, Less No abdominal scars, Less Permanent graft material intercourse. Permanent intercourse. Permanent No procedure. Condition risk of damage to major risk of damage to major decreases risk of graft material decreases graft material decreases least invasive of the Advantages Mayor may not worsen Non Surgical organs or blood vessels organs or blood vessels recurrence risk of recurrence risk of recurrence surgical protedures

" '. l. r :J: 0;; 0 ~. ~ 3 :J :J'" '" '"0­ cr 0 "2. n '"

"U ~. cr :z

~ o 3 3 :J '"CL '"C. Before Surgery After Surgery

Be aware of the risks associated with surgical mesh for • Continue with your annual and other routine check-ups and transvaginal repair of POP. Know that having a mesh surgery follow-up care. There is no need to take additional action may put you at risk for needing additional surgery due to mesh­ if you are satisfied with your surgery and are not having related complications. In a small number of patients, repeat complications or symptoms. surgery may not resolve complications. • Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, Ask your surgeon about all POP treatment options, including pelvic or groin pain or pain with sex, that last after your surgical repair with or without mesh and non-surgical options, follow-up appointment. and understand why your surgeon may be recommending • Let your health care provider know you have surgical mesh, treatment of POP with mesh. especially if you plan to have another surgery or other medical procedures. In addition, ask your surgeon these questions before you agree • Talk to your health care provider about any questions you may to have surgery in which surgical mesh will be used: have.

• Are you planning to use mesh in my surgery? If you had POP surgery, but do not know whether your • Why do you think I am a good candidate for surgical mesh? surgeon used mesh, ask your health care provider at your next • Why is surgical mesh being chosen for my repair? scheduled visit. • What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options? • What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh? • Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall? • If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product? • What can I expect to feel after surgery and for how long? • Which specific side effects should I report to you after the surgery? • What if the mesh surgery doesn't correct my problem? • If I develop a complication, will you treat it or willi be referred to a specialist experienced with surgical mesh complications? • If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences? • If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy? Selected Pelvic Organ Prolapse Treatment Options

Please be sure Lo request a copy of our Pelvic Prolapse Patient What can I expect after my surgery? Guide to pelvic floor reconstruction from your physician. There Your physician will provide specific post-operative guidance are several treatment options available to address your pelvic The following points are designed to offer general patient organ prolapse. Please consult with your physician to discuss information that we recommend you review with your physician the various treatment options including post operative care. Avoid constipation and straining with bowel mOv{,ments The Pinnacle! Pelvic Floor Repair Kits and the Uphold'" Vaginal Support Avoid driving until you can safely and comfortably operate a car System are surgical treatment options designed to correct vaginal wall Limit lifting objects during the recovery process prolapse utilizing vaginal incisions. They were developed by Boston Scientific. a leader in pelvic floor reconstruction solutions. Each kit contains a thin. You may experience light vaginal bleeding for up to light, synthetic mesh and an intra-vaginal delivery device for a minimally 2-4 weeks after surgery invasive approach Your physician may use the synthetic mesh assembly to You may have vaginal discharge for up to 6 weeks after surgery reinforce the vaginal wall back into place and stabilize your pelvic support You may feel some discomfort after surgery when sitting structures At the discretion of a physician, most patients resume normal See next page for a more complete list of potential Normal Female Anatomy activities within six to eight weeks complications and adverse events

The four sample illustrations below demonstrate the placements for the Pinnacle Pelvic Floor Repair Kits and the Uphold Vaginal Support System.

Pinnacle PeLvic FLoor Repair Kits Uphold VaginaL Support System

shown in shown in Anterior / Apical Posterior Post-hysterectomy Anatomy Natural Anatomy

for reinforcement of the for reinforcement of the vaginal wall for reinforcement of the vaginal wall at the vaginal apex vaginal wall near the bladder near the rectum/intestines Intended Use/Indications for Use Warnings/Potential Complications Adverse Events

Mesh based transvaginal surgeries are indicated for Hysterectomy may be needed in the future; Use of mesh may make a Potential adverse reactions that may be associated with tissue reinforcement and stabilization of fascial future hysterectomy more difficult due to tissue in-growth and scarring surgically implanled materials include structures of the pelvic floor in vaginal wall prolapse Continued screening and surveillance for cervical and lJterine disease Abscess formation/Foreign body reaction; where surgical treatment is intended. may be required; Regular pelvic exam, Pap test and endometnal Adhesion formation; biopsies should be continued as medically indicated AllergiC, hypersensitivity or other immune reaction; Contraindications Should dysuria, bleeding or other problems occur, contact your BrUising, hematoma, hemorrhage; physician immediately Constipation; Synthetic mesh is contraindicated for use in Refrain from heavy lifting, exercise and intercourse for a minimum of Dehiscence and/or necrosis; any patient in whom soft tissue implants are six (6) weeks after the procedure Your physician should determine Dyspareunia, contraindicated when it is suitable for you to return to normal activities. Erosion/ extrusion; Biologic mesh should not be used for patients In the event that infection presents post procedure, the entire Fistula formation; with a known history of hypersensitivity of collagen mesh may have to be removed or revised Granulation tissue formatIOn; or bovine products. Like all foreign bodies, the mesh may potentiate an existing Infection/Sepsis potentiation; Pregnant patients, or patients that are considering infection reaction or sepsis Inflammation (acute or chronic); future pregnancies Mesh and/or tissue contracture: Tissue responses to the implant could include local irritation at the The potential of future growth (e.g. infants, children) wound site, vaginal erosion or exposure through the urethra or other Organ perforation; Any pathology, including known or suspected uterine surrounding tissue, migration of the device from the desired location, fistula Pain, discomfort, irritation; pathology, which would compromise implant placement. formation, foreign body reaction, and inflammation. The occurrence of these Post-operative bleeding; Any pathology that would limit blood supply and responses may require removal or revision of the mesh Recurrent prolapse: compromise healing. Excess tension may cause temporary or permanent lower urinary tract Surgical site wound irritation, erythema, edema: Blood coagulation disorder obstruction and retention Ureteric injury, Ureter obstruction; AUloimmune connective tissue disease Mild to moderate incontinence may occur due to incomplete support. Urinary Incontinence; Known risks of surgical procedures for the treatment of prolapse include Renal insufficiency and upper urinary Urinary retention: tract obstruction. pain, infection, erosion/exposure, device migration, complete failure of the procedure resulting in recurrent or de Novo prolapse and/or incontinence Vaginal discharge; Pre-existing local or systemic infection. Treat the Vaginal shortening or stenosis; infection with the appropriate antiseptics and/or Punctures or lacerations of vessels, nerves, bladder, urethra, or bowel Vessel/Nerve injury/perforation; antibiotics to eliminate the infection before may occur during placement and may require surgical repair. Wound dehiscence performing a repair Overweight women may be prone to interoperative and postoperative complications (weight parameters to be determined by your physiclan)_ Boston SCIentIfic Delivering what's next:"

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 'IN'INW.boslonscientific.com/gynecology

© 2009 Boston Scientific Corporation or its affiliates. All rights reserved.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a phvsician. MVU8700 Rev A 5M 9/10 Have you ever felt a bulge or lump in your vagina? Yes No

Do you feel like something is falling out of your vagina? Yes No

Do you experience pain or discomfort during intercourse? Yes No

Do you experience vaginal pain, pressure, irritation, bleeding or spotting? Yes No

Do you experience problems with urination, particularly when coughing or sneezing? Yes No

Do you have difficulty with bowel movements? Yes No

Do you have delayed or slow urinary stream? Yes No

Do you have frequent lower back pain? Yes No

, Common Uses of Pessaries The vaginal pessary has a long The Use history, dating back thousands of And Care years! Ancient pessaries were To Improve or restore continence. Of Pessaries stones, pomegranates, linen, .. wool, and sponges. In the middle For diagnosis to determine if surgery is ages brass, cork, gold, and silver necessary. were the new materials. During .. the 1800's, the ring pessary was To delay or preclude surgery. developed. Vaginal pessaries were refined in the 1900's with .. advances in material science. As an alternative to surgery. Now there are silicone ones in .. many shapes and sizes. Few To manage uterine prolapse and vaginal medical inventions have stood wall hernias. the test of time so well as the .. pessary. To relieve a cystocele (bladder prolapse) or a rectocele. Compliments of Bioteque America Written by: Margaret G. Dorsey .. To relieve lower back pain caused by retroversion. +­ Diagnosis and therapy.. in obstetrics . To prevent miscarriage by relieving , BioteQue ' pressure on a weak cervix. America Inc. tJ ~~~~I~:bue Ifyou are a candidate for a healthcare provider and make an appoint­ Daily Care and HelpfuJ Hints: pessary, YOll wil/filld tlte ment for removal and cleaning. Do not be following i,,{ormatioll lIseful. alarmed if your appointment date is I can 'I remove my pessary, 1I0W what? weeks away. It is not unusual for pessaries A pessary is a vaginal prosthesis that has If you want to remove your pessary but to remain in place from 4 [0 12 weeks. evolved over centuries to become an can't, don't panic. Simply call your effective medical device to relieve the What is my respollsibility? healthcare provider and schedule an stress of a cystocele, a rectocele, a uterine appointment. or bladder prolapse, or the problems Your responsibility is to follow your healthcare provider's instructions, wear My pessary seems to have moved out of associated with urinary incontinence. your pessary, and keep all follow-up position and is uncomfortable. Pessaries come in various, shapes, sizes, appointments. If you should move, be and materials. They are perfectly safe and sure to notify your healthcare provider. Wash your hands, lie down and push the comfortable for long term usage. pessary up as far as you can. Don't worry, Will my pessary set off'tlle alarm at the it can't get lost. It's impossible to push Commonly asked questions: ailport? your pessary into your abdomen. Will I always have to use this pessary? Absolutely not. I see some discharge alld bleeding. What Not necessarily. Although pessaries are an Can 1 /tave sex with my pessary in should I do? alternative to surgery, your vaginal mus­ place? Sometimes pessaries can irritate body tis­ cles may strengthen to the extent that sue causing a slight discharge or bleeding. your pessary is no longer required. You certainly can. If you need to remove Call your healthcare provider if it persists. Sometimes pessaries are only required for your pessary, then do so. strenuous exercises like jogging or hiking. Will my pessary prevellt pregnancy: What do 1 do about daily bathillg: Certainly, if you are a candidate for sur­ gery, your pessary is only temporary until No, it will not. A pessary is not a contra­ Do not change your normal bathing rou­ corrective surgery can be performed. ceptive device. If you are sexually active, tine because you are wearing a pessary. wear a pessary and need to avoid preg­ Can a pessary hurt or become UIICOIll­ nancy, then discuss this with your health­ Should I douche? fortable? care provider. You do not have to douche unless A properly fitted pessary will never cause Call my pessary fall Ollt? instructed to do so by your healthcare pain or discomfort. You should be able to provider. pelform your normal daily activities with­ Yes it can. If your pessary is too small or out any di fficu Ity. you need a different type of pessary, sometimes it will fall out. Whenever this ~1~5~~~~ue How oftell shouLd I remove my pessary? happens, simply clean your pessary with mild soap and water and reinsert it. If it It is recommended that you remove your is a persistent problem, then call your 1-800-889-9008 pessary daily to clean it using mild soap healthcare provider for an appointment. Fax: 51 0-438-9388

and water. However, if you have difficulty You may need a different size or type. viSit our websitc ,11: \\\\\\".l>iotequc.({)111 removing your pessary, contact your or C' ma;1 u~ at: bioleque@\ILlI.\·"111 Regaining Control. Restoring Quality of Life

To learn more about pelvic organ prolapse, visit www. WebMD.com This brochure is not intended as a substitute for professional medical care, Only your physician can diagnose and appropriately treat your symptoms,

S

L An overview of . R. Bard, Inc Covington GA 30014 WW'" bardml!r.fILal :om • eVIC gan .. 2011 C. R. Bard Inc All Rights Reserv~d Pront.>rl In U.S.A. 1101-28 RO /11 THP P04/11 10M Pro apse Pelvic Organ Prolapse Notes:

Throughout a woman's lifetime, her body undergoes tremendous stress. The strain of pregnancy. The effort of childbirth. Even the trauma of certain gynecologic surgeries such as hysterectomies.

All of these stresses - accumulated over the years - can weaken the natural support structures of the pelvis, causing problems like pelvic organ prolapse, a feeling of vaginal fullness, chronic constipation and urinary incontinence. Any of these may require pelvic reconstructive surgery to repair.

The symptoms of a weakened pelvic floor can range from mild to debilitating, and can affect your ability to lead an active life - and even maintain sexual intimacy.

There are many non-surgical and surgical options which can correct problems associated with pelvic organ prolapse, and help restore a better quality of life.

What is Pelvic Organ Prolapse?

The vagina and its surrounding structures (bladder, rectum, etc.) are attached to the pelvis by connective tissues, These tissues help form walls around the vagina and ensure that normal urinary voiding and bowel movements can occur, As the pelvic muscles become weak, the connective tissues can fail, allowing pelvic structures like the bladder or rectum to bulge into the vaginal wall. This can cause the following symptoms:

A feeling of vaginal fullness, heaviness, or even pain Pain or discomfort during intercourse Loss of bladder control Involuntary urination or inconsistent urinary stream Difficulty with bowel movements Recurrent urinary infections

2 11 Notes: What causes Pelvic Organ Prolapse?

Pelvic muscles and connective tissues which have been weakened with age are the primary causes, but many other factors may playa role. These may include vaginal childbirth, previous vaginal surgeries, menopause, smoking, diabetes, obesity, repeated heavy lifting, chronic coughing, and chronic constipation. Sometimes pelvic organ prolapse can be caused simply by genetic factors.

What are the different types of pelvic organ prolapse?

When vaginal prolapse occurs, an organ has dropped (prolapsed) out of its normal position and can sometimes even protrude from the vagina. The definition of pelvic organ prolapse is different depending on what anatomic structure in the pelvis is pushing into the vagina, such as the bladder or rectum. When vaginal prolapse occurs, the upper part (apex) of the vagina has dropped to a lower position. It is possible for more than one organ to prolapse into the vagina at the same time.

pelvic/ Bone

Vagina Rectum

Nnrmal Female Anatomy

The different types of pelvic organ prolapse:

• Cystocele • Rectocele • Enterocele • Vaginal Vault Prolapse • Uterine Prolapse 10 Cystocele (pronounced "sis'to-sel") Are there risks with a procedure A cystocele occurs when the bladder falls into the vagina, As the connective tissue in the front wall using synthetic mesh materials? (sometimes referred to as the roof) of the vagina fails, its attachment to the pelvis may be lost, allowing As with any surgical procedure, the prolapse repair the bladder to drop into the vagina, This is the most procedure itself has the risk of certain complications common form of pelvic organ prolapse and is often such as the use of anesthesia, the surgical approach called a "dropped bladder", used, and how pre-existing conditions may affect the outcome, Your physician can further explain your specific risks and can provide a list of warnings associated with the procedure,

The synthetic mesh may strengthen the repair, although results vary from patient to patient. In addition, there are risks associated with the use of a permanent synthetic mesh There is a risk that the mesh material will protrude into the vagina causing difficulty and pain with sexual intercourse, Complications can also include localized fluid collection (blood, pus, clear serous fluid), erosion of the graft into surrounding tissues, infection, inflammation, pain, tightening of the repair (resulting in pain), perforation of neighboring tissues or organs, urinary incontinence and recurrence of vaginal wall prolapse, Given the permanency of synthetic mesh, post-procedure removal of the implant may be difficult. Additionally, repair of prolapse using synthetic mesh materials should not be undertaken if you are pregnant Rectocele (pronounced "rek'to-sel") or may become pregnant. Specifically related to the A rectocele occurs when the rectum falls into the ALYTE'" Y-Mesh Graft, the effectiveness of this product vagina, Similar to the cystocele, when the connective has not been validated by a prospective randomized tissue in the rear wall (the floor) of the vagina fails, the clinical trial, rectum can then bulge into, or even out of, the vagina, As the rectum bulges upward, this can cause difficulty If you experience any complications, please notify your or pain during bowel movements, physician immediately, Speak with your physician regarding his/her experience with this procedure, and the anticipated probability of any of these complications,

4 9 ~acrocolposu~pensionLSacro~olpoJ~exy Enterocele (pronounced "en'ter-o-sel") For treatment of prolapse at the top of the An enterocele occurs when the small intestines push vagina (vaginal vault or uterine prolapse), a the back of the vagina toward the opening. This usually sacrocolposuspension / sacrocolpopexy is a common occurs in conjunction with another form of prolapse and treatment. It involves attaching the top of your is repaired during the same procedure. vagina to a piece of graft material which is then secured to the top of your tailbone (bottom of your spine). This procedure can be done using either an open or minimally invasive approach.

Vaginal Vault or Uterine Prolapse repair with graft (Sacrocolposuspension /Sacrocolpopexy) Vaginal Vault Prolapse In women who have had a hysterectomy (no longer have a uterus), the natural support structures in the vagina provided by the uterus no longer exist. The top portion of the vagina can then push down into the lower vagina, causing vaginal vault prolapse.

k.,2009 Tim Peters and Company, Inc. All Rights Reserved. Developed in consultation with Patrrck Culligan, Mo. 8 5 Uterine Prolapse Non-Surgical Treatments For women who still have a uterus, the support structures holding the uterus in place can also be K~flel Exercises compromised, allowing the uterus to fall down into the Your physician may suggest an exercise program of vagina. This is called uterine prolapse. repeated contractions of the muscles of the pelvic floor. These muscles are identified as those that can be used to halt the flow of urine. Routine exercising of these muscles will help to build strength and maintain elasticity in the pelvis.

Pessary Devices A pessary is a device that is worn in the upper portion of the vagina similar to a diaphragm, and is designed to support the surrounding tissues. Your physician will determine the appropriate size and design of the pessary that will best support your prolapse.

Surgical Treatments

Traditionally physicians have used sutures to sew How is Pelvic Organ Prolapse weakened tissues back together. Sometimes, a piece of graft material (man-made or natural tissue) can be Treated? used to reinforce these repairs.

The best treatment for a specific type and severity of pelvic organ prolapse will vary from patient to patient. If your symptoms are mild, the doctor may recommend lifestyle changes, Kegel exercises to strengthen the pelvic muscles, or the use of a pessary to relieve the symptoms. When the symptoms are severe enough to affect your quality of life, your physician may recommend surgery.

'f)2009 Tim Peters and Company. Inc, All Rights Reserved. Developed m consultatton Cystocele repair with graft (Anterior repair) wW, Patrick Culligan, MD.

Rectocele repair with graft (Posterior repair)

6 7