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Studying the Risks and Benefits of Using Surgical Mesh for Hernia Repair

Studying the Risks and Benefits of Using Surgical Mesh for Hernia Repair

By: Sarah Hand, M.Sc.

Posted on: in News | Medical Device Clinical Trials News | Medical Device News | Medical Device Safety and Regulation News

According to a study conducted by researchers in Denmark, while the use of surgical mesh as a medical device for hernia repair has been associated with a lower risk of recurrence, these benefits also come with a risk of long-term mesh-related complications. The research was published in the journal JAMA, with results to be presented at this year’s American College of Surgeons Clinical Congress.

In 2012, approximately 190,000 elective incisional hernia repairs were performed in the US, making it one of the most common operations for general surgeons. At least half of these inpatient hernia repairs are reinforced using a prosthetic mesh, which is meant to reduce the risk of hernia recurrence.

In order to study whether the benefits of prosthetic mesh use outweigh the potential complications, researchers at Zealand University Hospital, in Køge, Denmark, and physicians at Hvidovre Hospital, in Hvidovre, Denmark, studied the outcomes of 3,242 patients who underwent the procedure in the country between 2007 and 2010.

Patients whose surgery was performed using open or laparoscopic techniques, using mesh as a stabilizer, were compared to those who received the surgery without the use of the medical device. The average age of the patients was 59 years, with 53 percent of them being women.

The majority of the patients, 54 percent, had laparoscopic mesh repair, while 35 percent underwent open hernia repair with the surgical mesh, and 11 percent had non-mesh repair. Study patients who underwent open mesh repair faced a lower risk of hernia recurrence at 12 percent, compared to patients who experienced laparoscopic mesh repair (10.6 percent), and non-mesh repair (17.1 percent).

Both the open and laparoscopic patients experienced an increasing number of complications associated with the surgical mesh – including bowel perforation, bowel obstruction and bleeding – for the duration of the follow up period. Nearly 6 percent of patients who received open mesh repair experienced one of these complications, compared to 3.7 percent for laparoscopic mesh repair patients, and just 0.8 percent for non-mesh repair.

“Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially off­set by long-term complications associated with its use,” said the study authors. “This observation, however, should be interpreted with caution because of the risk of selection bias. Larger, more complicated hernias are likely to be repaired with mesh, and small, simple hernias with little likelihood of long-term problems tend to be repaired without mesh.”

The researchers say that these results suggest a need for more clinical trials on the long-term effects of medical devices. In the case of most types of surgical mesh, the US Food and Drug Administration (FDA) approves the medical device based on its similarity to products already on the market, without requiring clinical trial data on the safety and efficacy of the product.

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