Septic Shock Reported With Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

Fran Lowry

September 28, 2009

September 28, 2009 (Hollywood, Florida) — The case of a 61-year-old woman who presented with septic shock 6 weeks after transvaginal placement of surgical mesh for pelvic organ prolapse and stress urinary incontinence was presented here at the American Urogynecologic Society 30th Annual Scientific Meeting.

Investigators say the report is newsworthy in part because it calls attention to problems with notification of device-related adverse events on the US Food and Drug Administration (FDA)'s Web site. Some believe the incidence of complications following mesh placement are "severely underreported."

The case correlates with an FDA alert that was sent out in October 2008 asking physicians to report complications associated with transvaginal mesh procedures, lead investigator Jessica Fischetti-Galvin, DO, from the Jersey Shore University Hospital Medical Center in Neptune, New Jersey, told Medscape Ob/Gyn & Women's Health in an interview after her presentation.

The patient did well immediately after her surgery except for 1 complaint — leg pain, Dr. Fischetti-Galvin reported. Lower extremity Doppler studies ruled out deep vein thrombosis and she was sent home.

Six weeks later, she presented to the emergency department of a community hospital. When she arrived, she was confused, hypotensive, and tachycardic, and had severe anemia (hematocrit, 18%), leukocytosis (white blood cell count, 67) with left shift, and coagulopathy (international normalized ratio, 2.7). Computed tomography imaging revealed multiple abscesses in her thighs, buttocks, and pelvis. The woman was transferred to Jersey Shore University Hospital, where she underwent a series of invasive procedures to remove the mesh and drain the abscesses, and received aggressive intensive care for septic shock.

"This case reminds us that mesh procedures, while they are very pioneering and help a lot of women, come with serious complications that we need to start reporting, because right now the paucity of data doesn't allow us to fully counsel our patients about these risks," Dr. Fischetti-Galvin told Medscape Ob/Gyn & Women's Health.

"There isn't a lot of literature describing serious complications with vaginal mesh surgery, and urogynecologists as a whole are split on whether they think vaginal mesh procedures are the way of the future or whether they are dangerous and have a lot of complications. We hope that more physicians will take it upon themselves to report to the FDA their serious complications after using the mesh."

She concedes that although most urogynecologists are aware of the FDA notification, they might be reluctant to report adverse events for a number of reasons.

"I think a lot of people are afraid . . [of] what kind of information . . they [will] have to give. Will their institution come under fire? Will their surgical technique come under fire? Can they report somebody else's surgical technique that failed?" Dr. Fischetti-Galvin offered.

"Unfortunately, I think that people are wary [about] reporting these things because then it shows that they had a complication with their own surgery," she observed.

According to Abbas Shobeiri, MD, chief of female pelvic medicine and reconstructive surgery and urogynecology at the University of Oklahoma College of Medicine in Oklahoma City, complications after mesh placement are severely underreported. This is due to a number of things. For 1, reporting problems to the FDA is a very cumbersome and complex process.

"Have you ever tried to use that database to report mesh complications? It's complicated to use because the FDA wants you to enter the serial number of the device on the Web site when you report the complication. There are many different companies that make these meshes. [If] patients don't go to the surgeon who did the surgery to begin with and we don't have the serial number, it makes it difficult to report these events because we don't even know what surgery was done. We see a lot of these," he said.

In the case of the patient in the case report, not going back to the surgeon who did her procedure delayed her care by at least 24 hours, said Dr. Fischetti-Galvin.

Unfortunately, patients who suffer infection or other complications often do not go back to their surgeons, Dr. Shobeiri told Medscape Ob/Gyn & Women's Health. "It's not that the surgeons do not refer the patient, it's just that the patients go somewhere else, because they are disgusted by the things that are happening. However, it is best to go back to the surgeon who saw you. That way they recognize the outcome of their procedure and they either don't do that procedure again or they revise their techniques."

Dr. Fischetti-Galvin admitted that reporting the complication was more difficult since the patient wasn't theirs to begin with.

"That is the key point," Dr. Shobeiri emphasized. "The FDA has asked surgeons to report complications, but sometimes they are not aware [of them] because their patients don't present back to them. We really think the number of complications reported to the FDA is grossly underestimated."

Dr. Fischetti-Galvin and Dr. Shobeiri have reported no financial relationships.

American Urogynecologic Society (AUGS) 30th Annual Scientific Meeting: Poster 21. Presented September 24, 2009.

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