PELVIC FLOOR REPAIR & TVT PROCEDURE

 

Sling & Vaginal Mesh Consent

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

 

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:

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

  • You have been diagnosed to have Pelvic Floor Prolapse & Stress Urinary Incontinence and you are scheduled to undergo a surgical procedure called Prolift & Trans-vaginal taping (TVT) using synthetic mesh.
  • Procedure will be done under:
    - Local anesthesia with sedation or
    - General anesthesia or
    - Spinal anesthesia
  • You will probably be discharged the same day of surgery or stay over night in the hospital or observation/extended recovery
  • You will have a Foley catheter and a vaginal packing in place after surgery and these will be removed the next day
  • Usually patients void after the removal of the catheter, however on a rare occasion, they don't and may require placement of Foley catheter for few extra days
  • This particular operation involves use of synthetic material - "mesh" in the vagina and on a rare occasion this mesh may extrude through the vaginal mucosa and may require additional surgery to correct. Mesh may also erode in the bladder or urethra on a very rare occasion
  • On a rare occasion, due to extensive dissection to repair the pelvic defect , the vagina may become narrow or develop scarring making intercourse difficult
  • This surgical procedure is very simple and doesn't require any incisions on the skin. There is one small incision in the vaginal wall. There will be 4-6 small openings on the skin of your thigh and perineum
  • Before the operation:
    - No aspirin or any blood thinning medications
    - Nothing to eat or drink after midnight on the evening prior to the surgery
    - You may take necessary medications with a sip of water in the morning
  • We have also provided a CD and literature of the procedure

Post Operative Instructions:

  • Take it easy for 3-4 weeks after your operation
  • There are no dietary restrictions following your surgery
  • Please take mild laxative such as Milk of Magnesia, Colace or Metamucil everyday for 3-4 weeks
  • Please drink plenty of water every day
  • Avoid alcoholic beverages for 3-4 weeks
  • Avoid strenuous exercise for 3-4 weeks
  • You may walk, but do not run
  • Avoid lifting over 15 pounds for 3-4 weeks
  • You should not drive a car for 3-4 weeks
  • Avoid sexual intercourse for 6-8 weeks
  • Avoid tampons or self examination for 6-8 weeks
  • There are sutures on the vaginal wall - they will dissolve on their own. Please do not touch or try to remove them
  • You may shower or take a bath anytime
  • You should use a small sanitary napkin for 6-8 weeks as there will be some bleeding or discharge during the healing time
  • If there is excessive bleeding, please call our office
  • We have prescribed for you an antibiotic. Please take as instructed
  • We have prescribed pain medication for you. Please take them as necessary
  • If you are experiencing severe pain, fever, chills, or swelling, please call our office
  • You may return to work 2-3 weeks after your surgery; however, if your work requires heavy lifting or heavy duty work you may want to wait 3-4 weeks before returning to work
  • Please call our office to arrange a follow-up visit in 3-4 weeks time
  • Should you have any questions, please don't hesitate to call us

 

 

Patient Name: _____________________________________

 

 

 

Patient Signature: ___________________________________