Pelvic Organ Prolapse
- Pelvic Organ Prolapse
- What is POP?
- Sites of POP
- Treatment Options
- In Summary
- FDA Communication Regarding Use of Transvaginal Mesh
Pelvic organ prolapse (POP) is a hernia of the pelvic organs to or through the vaginal opening. Approximately 200,000 operations are performed yearly in the United States for POP. Although not life threatening, POP is life altering and results in significant quality of life changes in women.
What is POP?
The pelvic organs (bladder, uterus and rectum) are supported by a complex “hammock” that includes the pelvic muscles, fibrous or ligamentous support structures, and their attachment to the bony anatomy of the pelvis (Diagram 1). Damage to these support systems results in descent of the pelvic organs. POP is not a new problem; POP and its consequences have been written about since 2000 B.C. While minor degrees of POP affect up to 50% of women who have had a vaginal delivery, only 20% have symptomatic POP that prompts women to seek care. In general, POP that does not extend beyond the vaginal opening is asymptomatic and does not require care, while POP that extends beyond the vaginal opening is generally bothersome to women. Treatment options for POP are limited and include the use of pessaries, surgery or watchful waiting. Suboptimal surgical results as well as high recurrence rates after treatment have prompted many providers to view prolapse as a chronic disease. Risk factors for the development of POP include difficult vaginal deliveries, family history of POP, obesity, advancing age, prior hysterectomy, and conditions which chronically increase intra-abdominal pressure, such as asthma or constipation.
Commonly, patients with severe POP report feeling or seeing a “ball” or protrusion from the vagina. Other prolapse symptoms are often vague and nonspecific. Patients with mild POP can report feelings of heaviness or pressure that may be present all the time or only after a long day of being on their feet or after heavy physical exercise. POP commonly occurs with other pelvic floor disorders including bladder and bowel problems such as urinary or anal incontinence, constipation and overactive bladder. Symptoms for one pelvic floor problem should prompt questioning for all other disorders as patients often have more than one pelvic floor problem. Fortunately, mild POP rarely affects sexual function although more severe POP may lead to decreased rates of sexual activity.
Prolapse or support problems can affect one or multiple organs of the pelvis. Weakness of the frontside vaginal wall near the bladder results in a cystocele, often called a “dropped bladder” (Diagram 2). Weakness of the vaginal ceiling results in uterine prolapse, known as an enterocele (Diagram 3). Defects of the backside vaginal wall near the rectum results in a rectocele (Diagram 4).
Diagram 2: Cystocele (prolapsed bladder)
Diagram 3: Uterine prolapse
Diagram 4: Rectocele
Mild pelvic organ prolapse that is asymptomatic does not require treatment. Some prolapse will improve on its own with watchful waiting, although it is not possible to identify whose POP will improve with time. Although there are limited non-surgical management options for POP, there is emerging information that pelvic floor exercises, or Kegels, may have some limited effectiveness in addressing symptoms of POP. Other non-surgical options for treatment of symptomatic POP include pessaries.
Pessaries are silicon devices that come in a variety of shapes and sizes and are placed in the vagina to provide support to the pelvic organs. Since women come in all shapes and sizes, pessaries need to be fitted to the individual. There are many different types of pessaries and multiple sizes of each type. Fitting is by trial and error. A successful pessary is one that is comfortable, is retained with Valsalva and treats POP symptoms adequately. Pessaries do require upkeep and need to be removed and cleaned on a regular basis. Most women can learn to care for their pessaries themselves, however, women who cannot care for their pessaries need to have the pessary removed and cleaned on a regular basis by their provider. For many, local vaginal estrogen is prescribed for use in conjunction with a pessary for comfort, lubrication to reduce the risk of irritation or ulceration, and a lower incidence of urinary tract infections.
Although there are limited non-surgical management options for POP, there is emerging information that pelvic floor exercises, or Kegels, may have some limited effectiveness in addressing symptoms of POP. For assistance in performing the exercises correctly and consistently, consider ordering the Women’s Pelvic Floor Muscle Exercises Instruction Kit from NAFC. It includes a manual with descriptions and detailed drawings, a motivational video and instructional audio recording. Instruction by a physical therapist or other expert may be necessary, as well as the help of biofeedback in locating the muscles to contract.
Reconstructive surgery for POP is an option. Prolapse procedures are done to provide support for the pelvic organs. Ultimately, the purpose of the surgery is correct the anatomy as well as provide better bowel, bladder and vaginal function.
Prolapse repairs can be done transvaginally, abdominally, laparoscopically and/or robotically (when a scope is placed through the belly button). Correcting all support defects is paramount in the surgical approach to POP. However, given the nearly 30% recurrence rate with surgical approaches, pelvic surgeons are constantly looking for new ways to approach this problem.
Approximately 11% of women will have surgery for POP prior to 80 years of age. Unfortunately, nearly 30% of these women will need another surgery due to failure or recurrence of prolapse or treatment of another pelvic floor problem.
What is the best surgery for the treatment of POP? Since women are individuals, the best treatment is a decision that needs to be made between a woman and her surgeon. In general, 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. In addition, the use of permanent mesh is associated with complications, some of which may require additional surgeries to correct. The most common complications associated with the use of permanent mesh to repair POP are urinary tract infections (4%), exposure of the mesh into the vagina (3%), and pelvic or genital pain (2.5%); other problems include erosion of the mesh, or perforation, into organs such as the bladder or urethra, urinary retention, and, possibly, mesh shrinkage. 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 trans-vaginal 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 post-operatively. 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.
Visit our "Tools for Patients" page and scroll down to read on how to better prepare yourself for the discussion of surgical procedures with your health care provider.
Since women are individuals, the best treatment is a decision that needs to be made between a woman and her surgeon.FDA Communication Regarding Use of Transvaginal Surgical Mesh
Three 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 three 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 mentioned 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 8-9, 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 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.
Already had surgery for prolapse or SUI?
To learn how to report adverse events to the FDA visit, FDA MedWatch.
The FDA safety update intended to inform patients and health care providers about complications associated with surgical mesh. Organizations presented information to an FDA advisory panel underlining case-specific details to patients with Pelvic Floor Disorders. NAFC has formed a position statement that you may read here: NAFC Position Statement on the Use of Vaginal Mesh in Pelvic Surgery. 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:
- AUGS and ACOG Joint Committee Opinion on Vaginal Placement of Synthetic Mesh for POP (11/21/2011)
- Committee Opinion #513 "Vaginal Placement of Synthetic Mesh for Pelvic Organ Placement" is published in the December 2011 issue of Obstetrics & Gynecology. (12/2011)
You may also listen to a podcastby Dr. Marie Fidela Paraiso, urogynecologist at the Cleveland Clinic, on the subject.
Pelvic Organ Prolapse Study
In a recent study NAFC seeked to identify how pelvic organ prolapase impacts the lives of women. The purpose was to understand the barriers and frustrations that women encounter in seeking diagnosis and intervention.
As the population grows older, the number of women who develop POP will increase. Preventive strategies have yet to be identified and are needed. Some risk factors for POP cannot be changed (such as your family history), but others, including avoiding constipation can. Other prevention strategies, such a cesarean versus vaginal delivery, remain unproven.
Surgical mesh is used to repair weakened or damaged tissue. Because of better outcomes, surgeons often prefer to use mesh for anterior repair in the case of a cystocele or in cases of prior prolapse and thus already compromised tissue. In urogynecologic procedures, it is permanently implanted to reinforce the vaginal wall or to support the urethra. The mesh is porous but may be synthetic or biologic. Recently, the FDA issued safety communications regarding the potential for serious complications associated with vaginal mesh, of all constructions, in pelvic surgery for prolapse. Before reaching a decision and consenting to a surgical procedure, patients are urged to educate themselves and ask their surgeons about all treatment options, the doctor’s experience with such repairs, and the doctor’s ability to address any and all complications that may occur during and after surgery