PELVIC ORGAN PROLAPSE PROCEDURES
For those contending with prolapse issues, reconstructive surgery for Pelvic Organ Prolapse (POP) is a viable option. Ultimately, the purpose of the surgery is to correct the anatomy as well as provide better bowel, bladder, and vaginal function.
Take a moment or two to reacquaint yourself with the female anatomy so you can understand how the components are interwoven and connected.
Prolapse or support problems can affect one or multiple organs of the pelvis. Weakness of the front-side vaginal wall near the bladder results in a cystocele, often called a “dropped bladder”. Weakness of the vaginal ceiling results in uterine prolapse, known as an enterocele Defects of the backside vaginal wall near the rectum results in a rectocele.
Prolapse repairs can be done transvaginally, abdominally, laparoscopically, and/or robotically (i.e., when a scope is placed through the belly button). Correcting all support defects is paramount in the surgical approach to POP. Abdominal repairs are thought to have higher success rates at the cost of increased morbidity when performed through a large incision.
Because of less than optimal success rates with traditional repairs, pelvic surgeons are constantly looking for new surgeries to approach this problem. Many surgeons are using vaginal grafts (made of synthetic and biologic materials) in attempts to improve long-term success rates; however, limited research has been done to prove that these methods improve results without increasing complications. While use of permanent mesh that is placed vaginally may improve vaginal support, many women have good results with repairs that are performed using their own tissues.
Research is currently being done to determine if the benefits of using mesh grafts in POP surgical repairs for greater durability sufficiently outweigh the risks of undesirable adverse consequences. Limited research to date indicates that women who are older, smoke, are diabetic, or have had a hysterectomy are at higher risk for these more common complications.
For women who never plan on having sexual intercourse again, there are simple transvaginal surgeries that have nearly a 100% success rate. In these techniques the vagina is sewn shut and shortened so that it no longer prolapses. After these surgeries, vaginal intercourse is impossible. These techniques are ideally suited for the elderly patient with multiple medical problems that would otherwise place her at increased risk with a reconstructive approach.
Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, in women is diagnosed using pelvic examination. A medical history is also important to elicit prolapse-associated symptoms, since treatment is generally indicated only for symptomatic prolapse.
The Baden-Walker scale is often used to evaluate the severity of the condition from 0 to 4. Another evaluation tool, the Pelvic Organ Prolapse–Quantification (pelvic organ prolapse-Q; stages 0 through IV) is an international system that is more complex and involves taking several measurements. Both produce reliable results, giving your physician and you the information to proceed.
Since POP surgery is fairly invasive, recovery will take time. Among the things to anticipate:
- Postoperative Pain - Pain medication can be controlled and delivered by the patient via an intravenous patient-controlled analgesia (PCA) pump or by injection (pain shot) administered by the nursing staff. You may experience minor transient shoulder pain (1-2 days) related to the carbon dioxide gas used to inflate your abdomen during the laparoscopic surgery.
- Bladder Spasms - Bladder Spasms are commonly experienced as a moderate cramping sensation in the lower abdomen or bladder and are common after colposuspension. These spasms are usually transient and often decrease over time. If severe, medications can be prescribed by your doctor to decrease the episodes of these spasms.
- Nausea - You may experience transient nausea during the first 24 hours following surgery, which can be related to the anesthesia. Medication is available to treat persistent nausea.
- Urinary Catheter - You can expect to have a urinary catheter (i.e., Foley), which is placed in the operating room under anesthesia, draining your bladder for approximately 1-2 days after the surgery. It is not uncommon to have blood-tinged urine for a few days after your surgery.
- Vaginal Packing - Vaginal gauze packing is routinely placed at the end of the operation while the patient is under anesthesia. This packing will typically be removed the next day.
- Diet - You can expect to have an intravenous catheter (IV) in for 1-2 days. (An IV is a small tube placed into your vein so that you can receive necessary fluids and stay well hydrated. In addition, it provides a route to receive medication.) Most patients are able to tolerate clear liquids the first day after surgery, and a regular diet the following day. Once on a regular diet, pain medication will be administered by mouth instead of by IV or shot.
- Fatigue - Fatigue is common and should start to subside in a few weeks.
- Incentive Spirometry - You will be expected to do some very simple breathing exercises to help prevent respiratory infections by using an incentive spirometry device. These exercises will be explained to you during your hospital stay. Coughing and deep breathing is an important part of your recuperation and helps prevent pneumonia and other pulmonary complications.
- Ambulation - On the day after surgery it is very important to get out of bed and begin walking with the supervision of your nurse or family member to help prevent blood clots from forming in your legs. You can expect to have SCD's (sequential compression devices) along with tight, white stockings on your legs to prevent blood clots from forming in your legs while you are lying in bed.
- Hospital Stay - Length of hospital stay for most patients is 1-2 days.
- Constipation- You may experience sluggish bowels for several days to a week after surgery. Suppositories and stool softeners may be given to help with this problem. Taking 1 tsp. of mineral oil and milk of magnesia at home will also help to prevent constipation.
IS SURGERY FOR ME?
With the guidance of your physician, only you can make the final decision on whether to go through with surgery. You must weigh the risks versus the rewards and try to envision your life after surgery. Look past the short-term pain associated with the procedure and try to imagine the impact on your lifestyle.
Once you review the pros and cons with your physician and understand the procedure to the best of your ability, only then can you make the decision right for you.
FDA STATEMENTS REGARDING TRANSVAGINAL SURGICAL MESH
Six years ago the FDA issued (on October 20, 2008) a Public Health Notification (PHN) regarding potential complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The PHN provided recommendations and encouraged physicians to seek specialized training in mesh procedures, to advise their patients about the risks associated with these procedures, and to be diligent in diagnosing and reporting complications.
In the six years since the FDA issued this PHN, the following has taken place:
- On July 13, 2011, the FDA issued an update to the PHN in which it maintained that adverse events for POP mesh repair are not rare, as previously reported, and questioned the relative effectiveness of transvaginal mesh as a treatment for POP as compared to non-mesh surgical repair. Although the PHN made mention of mesh for use in SUI repair, the FDA did not address this SUI treatment approach and communicated that further evaluation would be required prior to releasing any statement in that regard.
- The update continued to encourage physicians to seek specialized training in mesh procedures, to consider the risks associated with these procedures when making patient prescribing decisions, to advise their patients about these risks, and to be diligent in diagnosing and reporting complications.
- On September 8 and 9, 2011, the FDA convened an Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to further address the safety and effectiveness of transvaginal surgical mesh. The panel examined the use of transvaginal surgical mesh products to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
- At the hearings held on September 8 and 9, 2011, representatives of the Transvaginal Mesh Device Manufacturers’ Working Group presented information to the FDA panel. This working group included representation by American Medical Systems, C.R. Bard, Boston Scientific, and Ethicon Women’s Health and Urology, in collaboration with the Advanced Medical Technology Association (AdvaMed) and Dr. Suzette Sutherland, a board-certified urologist focused in the area of female pelvic medicine and reconstructive surgery. We believe that this working group presented a very strong case for safety, efficacy, and continued classification of mesh as a Class II device to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
- The recent FDA panel hearings in September 2011 supported recommendations by the agency that it reclassify transvaginal surgical mesh products for POP to Class III (pre-market approval) and require manufacturers of existing products to conduct additional post-market surveillance studies. Regarding surgical mesh devices for treatment of SUI, the panel supported the agency recommendation that such devices remain in Class II. Regarding retropubic and transobturator slings, the panel supported the working group position that no additional post-market surveillance studies are necessary. Regarding mini-slings, the panel recommended pre-market studies for new devices and additional post-market surveillance studies.
- The FDA issued on January 3, 2012, requests for post-market surveillance studies of all previously approved and currently available vaginal mesh devices for pelvic organ prolapse (POP) and single-incision mini-sling devices with mesh for stress urinary incontinence (SUI). None of these devices were recalled and all remain available for usage in surgical procedures in women. These are all Class II 510K devices that had not required such data for their approval by the FDA. The FDA continues to assess whether to reclassify future vaginal mesh devices for POP from Class II to a stricter class III category. For more information, please visit the FDA's update.
- The FDA safety update is intended to inform patients and healthcare providers about complications associated with surgical mesh. NAFC has formed a position statement that you may read here: NAFC Position Statement on the Use of Vaginal Mesh in Pelvic Surgery.
- Organizations presented information to an FDA advisory panel underlining case-specific details to patients with pelvic floor disorders. AUGS has also created a statement for patients who have undergone treatment using mesh or may be candidates for treatment. To view the AUGS/ACOG resources, please visit:
Committee Opinion #513 "Vaginal Placement of Synthetic Mesh for Pelvic Organ Placement" is published in the December 2011 issue of Obstetrics & Gynecology. (12/2011)