Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

FDA Warning: Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

On July 13th, 2011 the FDA posted a notice about complications related to the usage of surgical mesh to repair pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). This notice serves as a follow up to a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh places through the vagina (transvaginal placement) to treat POP and SUI released by the FDA on October 20th, 2008. Due to the updated analysis of adverse events reported to the FDA and complications described in the scientific literature, surgical mesh for transvaginal repair of POP has been identified by the FDA as an area of continuing serious concern.

The 2008 notice reported that there were “over 1,000” reports to the FDA for adverse events related to surgical mesh devices used to repair POP and SUI for the 3 year period of 2005-2007. Though it is common for adverse events reporting to increase following an FDA safety communication, there is concern that the number of adverse events remains so high. The FDA reported that January 1st, 2008 through December 31st, 2010, they had received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI.

Through the 2008-2010 period the most frequent complications reported to the FDA in relation to surgical mesh devices for POP repair included pain, infection, pain during sexual intercourse, organ perforation, urinary problems, and the most common and consistently reported mesh-related complication: mesh erosion through the vagina. 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.

FDA conduct systematic review

In order to better understand the use of surgical mesh for POP and SUI, a systematic review of published scientific literature from 1996-20011 was conducted by the FDA in order to evaluate its safety and effectiveness. The findings by the FDA revealed that transvaginal POP repair with mesh do not improve symptomatic results or quality of life over traditional non-mesh repair. The literature also revealed that the meshed used in transvaginal POP repair introduces new risks not present in the traditional non-mesh surgery for POP repair, and mesh placed abdominally for POP repair appears to result in lower rates of mesh complications than transvaginal POP surgery with mesh. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

Recommendations for Health Care Providers

The FDA continues to recommend that health care providers should:

  • Obtain specialized training for each mesh placement technique and be aware of the associated risks
  • Be vigilant for potential adverse events from the mesh
  • 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 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 paid 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.
  • Recognized that in most cases POP can be treated without mesh
  • Choose mesh surgery only after weighing the risks and benefits of using mesh as versus other surgical and non-surgical procedures
  • 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

Recommendations for Patients

Patients should be aware of the risks associated with surgical mesh for transvaginal repair of POP and know that having a mesh surgery may put them at risk for needing additional surgery due to mesh-related complications. Patients should also consult with their surgeon about all POP treatment options, including those that do not include the use of surgical mesh. Patients should also ask their surgeon the following questions:

  • 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?
  • What are the pros and cons for 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?
  • 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?

After Surgery

Once you have had surgery you should continue your annual and other routine check-ups and follow-up care. If you are satisfied with your surgery and you are not having complications or symptoms, there is no need to take additional action. You should notify your health care provider if you do have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sex. Further you should let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.

In the event that you do experience adverse events associated with surgical mesh you should promptly report the events to the FDA so they can better understand the risks associated with medical devices. You should also file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Chicago Defective Medical Device Lawyers

At the Phillips Law Offices, each Chicago defective medical device lawyer offers the highest quality legal services to malpractice victims throughout Illinois. Please call us at (312) 346-4262, or contact us online today for a free attorney consultation about your defective medical mesh case.