FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

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 serious 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.1

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 during 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 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 may or 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:
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
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 pain.
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 transvaginal 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

Continue 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, including persistent vaginal bleeding or discharge, pelvic or groin 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.
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 DSMICA@FDA.HHS.GOV, 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 Mesh7
Federal Register Notice Ammendment: Urogynecologic Surgical Mesh8

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm