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 Practitioner:

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 manufacturers 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 the 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.

Recommendations

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 life, 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.

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, by phone at 1-800-FDA-1088, or obtain the fillable form online, 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. 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 .

Sincerely,

Daniel G. Schultz, MD

Director

Center for Devices and Radiological Health

Food and Drug Administration

Coast IRB has urged authorities to investigate and prosecute the perpetrators whose actual identities remain unknown. Several felony fraud violations and potential RICO may have been committed. “We are informing the media in the hopes of alerting those who might otherwise become study subjects that this appears to be a fraudulent trial,” said Coast IRB CEO Daniel Dueber. “We are also doing so because we want other institutional review boards to learn of our experience and avoid review of this trial pending the result of federal and state investigations”.

Coast IRB discovered the evidence in a routine audit of the trial. Coast IRB discovered that credentials for the principal investigator were forged and that neither the principal investigator nor the medical director was licensed in Virginia. The Department of Health Professions from whence the forged license was allegedly issued reported no record of granting license to the person involved, no record of the license number listed on the forged credentials, and no issuance of licenses in the history of the Commonwealth in the format presented by the study sponsor. Coast IRB further discovered through on-site visit the address for the clinical trial organization where testing was presumably taking place, was in fact a strip mall. A 510(k) FDA number given for the medical device did not exist in FDA’s records.

Coast IRB is one of the largest independently owned IRB’s. Its mission is to protect the rights and welfare of subjects in clinical trials by providing ethical and thorough review. It is located in Colorado Springs, Colorado.