FDA logo 200March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI). 

The experts  suggested that because of the number of POP complications at the time (1,503), that mesh for POP be reclassified from Class II to a Class III or high-risk device. That would require a rigorous premarket review process before mesh manufacturers could sell their product, unlike the pre-market notification that is required now. Many critics suspect POP surgical mesh would never be approved for safety and efficacy if that happened.

But no changes were made and at this time surgical mesh for POP and SUI remains Class II or a low-to-moderate-risk medical device.

The expert panel said it would further consider reclassifying SUI surgical mesh and the FDA promised an update at a later time.

With no notification, the FDA on Wednesday, March 27, updated its information on SUI mesh.

What Is New? SUI Adverse Events Increasing

The agency says it has analyzed adverse event reports, conducted epidemiological research on the safety and effectiveness of surgical mesh for POP and SUI and collaborated with professional societies to understand postmarket performance.

The timing is interesting on the latter point. It should be noted that the FDA update comes one day after the American Urogynecologic Society (AUGS) issued a new policy statement that resists any suggestion mesh use be banned or severely restricted. See it here.

What’s new is the FDA has continued to monitor SUI mesh injuries.

Back in July 2011 (here) when the second Safety Communication was issued by the FDA saying mesh complications were “not rare,” it released the number of adverse events that had come into the FDA at that time.

“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.”

The agency continued its review of SUI complications and now reports from January 1, 2008 through September 30, 2011, the FDA received “1,876 reports of complications associated with surgical mesh devices used to repair SUI.”

That represents more than a 36% increase in adverse event reports to the FDA in nine months.

Advocating SUI Mesh

While advising not every woman experiencing SUI will need surgery the FDA appears to endorse sling surgery over non-mesh repairs on the What is Stress Urinary Incontinence? page (here) by saying:

“The use of surgical mesh slings to treat SUI provides a less invasive approach than non-mesh repairs, which require a larger incision in the abdominal wall. The multi-incision sling procedure can be performed using three incisions, in two ways: with one vaginal incision and two lower abdominal incisions, called retropubic; or with one vaginal incision and two groin/thigh incisions, called transobturator. There is also a “mini-sling” procedure that utilizes a shorter piece of surgical mesh, which may be done with only one incision.”

Suggested Patient Questions

The FDA update on SUI includes an extensive list of questions a patient should ask her doctor when she’s considering an incontinence repair (here).  Without seeing the original page it is difficult to assess if this is new information. Questions into the FDA media office about that are pending at this time.

 

Considerations about Surgical Mesh for SUI

The newly updated FDA page (here) says 250,000 SUI surgeries were performed in 2010, according to the industry, and the FDA says the safety and effectiveness of multi-incision slings is well established among patients who were followed up to one-year.  Mini-slings for SUI safety and effectiveness “have not been adequately demonstrated” and have not been compared to multi-incision slings for safety and effectiveness.

Mesh sling surgeries for SUI have a reported 70-80 percent success rate at one year. A similar rate of success is reported at one year for non-mesh repairs. The FDA page does not say what constitutes “success.” As we’ve learned from testimony in the Linda Gross trial, success is sometimes defined as the correct placement of a pelvic organ and not the quality of a woman’s life after the surgery.

The most common complications coming into the FDA for surgical mesh slings for SUI repair, in descending order of frequency, include:

pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.”

The FDA suggests partial removal may be a remedy.

Recommendations for Health Care Providers

 

What’s new may be an additional recommendation to health care providers that encourages the surgeon receive specialized training for each SUI mesh placement technique. The American Urogynecologic Society (AUGS) in its policy statement just released also recommends more specific training for doctors.

The FDA also encourages doctors to be fully informed about:

  • The likely success of transvaginal SUI surgery compared to a non mesh surgery
  • The potential postoperative complications and its effect on the quality of life
  • That  there is limited information about outcomes after one year
  • The specific product to be used
  • That a mesh sling is a permanent implant
  • That SUI surgery using mesh can make any future surgeries more challenging and can “put the patient at risk for additional complications and surgeries.”
  • Ensure the patient understands the post-operative risks and potential complications
  • Provide the patient with the labeling or brochure

You’ll recall that during the Linda Gross v. Ethicon case, it became clear that there was a “failure to provide adequate warning” to her implant surgeon Dr. Benson by a jury vote of  7-yes and 2-no. That means the surgeon also may not have enough information to provide an adequate “informed consent.”

*Editors Note* Without being able to compare the original FDA pages to this newly updated information it is difficult to determine which represents a departure for the FDA in terms of SUI mesh. MDND requested a comparison to answer that question on Thursday. We’ll update you when that is forthcoming. #