PELVIC FLOOR REPAIR & TVT PROCEDURE

Sling & Vaginal Mesh Consent

For management of stress urinary incontinence, cystocele, rectocele and pelvic organ prolapse.

• There are several surgical options available for the correction of stress urinary incontinence and pelvic organ prolapse.
• All surgery has associated risks including but not limited to bleeding, infection and pain.
• Additional risks assumed by patients for sling procedures and pelvic organ prolapse include but are not limited to injury to the vagina, the bladder and the urethra. More serious complications reported with sling procedures include injury to intestines, major blood loss needing transfusions and even death.
• As a result of the procedure with or without a complication some patients will require the use of a Foley catheter or need to perform self intermittent catheterizations for various lengths of time. For some patients this could be indefinitely.
• As a result of the procedure with or without a complication some patients will have new onset bladder complaints or worsening of existing bladder complaints such as but not limited to urgency and frequency of urination.
• In general, success rates for sling procedures reported in the medical literature range from 60-90% five years after surgery. No surgery is ever 100% successful. Medical literature also reports the highest success rates for treating pelvic organ prolapse with the use of synthetic mesh.
• Success is defined as a reduction of the loss of urine to an acceptably low level for the patient.
• Complete dryness might never be accomplished.
• The medical literature reports as many as 10% of slings will need a reoperation or removal procedure. Reasons include but are not limited to bladder obstruction, urgency and/or frequency or urination, erosion of sling into the urethra or out of vagina and pain. The success of a reoperation reported in the medical literature is high.
• Issues unique to the use of synthetic mesh to correct pelvic organ prolapse include but not limited to exposure of the mesh post operatively, erosion of the mesh into the bladder or into the rectum.
• Although synthetic slings have been used in the United States since the late 1990's on October 20, 2008 the Food & Drug Administration posted a warning statement related to the use of synthetic mesh in pelvic surgery. A copy has been provided to you and should be read before surgery.

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Issued: October 20, 2008

Dear Healthcare Pracitioner:

This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.

Nature of the Problem

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufactures of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific Characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

Physicians should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks. 
• 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 like, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.  

Additional patient information can be found on the following FDA Consumer website at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html

Reporting Adverse Events to FDA

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for mandatory reporting. You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online at
www.fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, or obtain the fillable form online at www.fda.gov/MedWatch/getforms.htm, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

Getting More Information

If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.

Preoperative Instructions