Robotic Hernia Repair Surgery Linked To Higher Rates of Hernia Recurrence: Study

The findings of a new study suggests that hernias repaired through robotic surgery are more likely to recur than those addressed through laparoscopic and traditional open procedures, raising questions about the benefits and risks associated with the more expensive alternative surgery technique, which has been marketed as a superior treatment option in recent years.

Nearly 14 out of every 100 patients who undergo ventral hernia repair through robotic surgery are likely to have that injury return within 10 years, which can lead to potential injuries, complications and the need for more surgical procedures, according to a group of University of Michigan researchers, led by Dr. Brian T. Fry of the Department of Surgery. The findings were outlined in a report published last week in the medical journal JAMA Surgery.

Surgical robots are complex medical devices featuring a number of remotely controlled arms that are used to perform various procedures. The robot’s arms are controlled by a surgeon through the use of hand and foot controls, while sitting at a console that provides a virtual reality representation of the patient’s internal organs. The devices are promoted as a minimally invasive alternative to traditional surgery, allowing patients to recover and leave the hospital faster than laparoscopic or other types of surgical procedures.

However, there have been serious questions raised about the safety and efficacy of surgical robots in recent years. For example, Intuitive Surgical has faced da Vinci robotic surgery lawsuits over the past decade, which have included reports of thermal burn injuries and lacerations to organs, as well as other surgical complications.

In this latest study, Dr. Fry and his team conducted an analysis of 161,415 Medicare claims involving adults who either underwent elective implant ventral, incisional, or umbilical hernia repair procedures from 2010 through 2020. The researchers looked at what type of hernia repair surgery they underwent, including robotic-assisted, laparoscopic or open surgery, and looked at their outcomes.

According to the findings, from 2010 to 2020 the number of robot-assisted hernia repair surgeries increased tenfold, from 2.1% to nearly 22% of all such procedures. During that same time, the proportion of laparoscopic procedures dropped from nearly 24% to just over 11%. Most hernia repair procedures are conducted through open surgeries, but the percentage of such surgeries has dropped from 74% to 62%.

However, the researchers found 13.4% of patients who underwent robotic hernia repair surgery saw the problem recur within 10 years. Laparoscopic and open surgery had a lower recurrence rate of just above 12% by comparison. The researchers noted that the numbers stayed consistent regardless of the number of surgeries the surgeon had performed and account for patient factors such as age, sex, race, comorbidities, and what type of hernia the patient suffered.

“This study found that the rate of long-term operative recurrence was higher for patients undergoing robotic-assisted ventral hernia repair compared with laparoscopic and open approaches,” Fry and his team concluded. “This suggests that narrowing clinical applications and evaluating the specific advantages and disadvantages of each approach may improve patient outcomes following ventral hernia repairs.”

The researchers noted that robotic surgery is an increasing trend in the medical field. However, they suggested that doctors look at robotic-assisted surgery as being most useful during complex surgeries, in cases where laparoscopic surgery will not be able to do the job. They called for health care professionals to narrow the clinical applications for robot-assisted, laparoscopic and open surgery, and look at the advantages and disadvantages of each approach for each patient’s situation.

Hernia Repair Surgery Lawsuits

The findings come as a number of surgical mesh manufacturers face hernia repair surgery lawsuits, alleging that products implanted to repair hernias failed due to design defects, often resulting in recurrences and other painful complications when the mesh failed.

The bulk of that litigation is currently pending against C.R. Bard, which faces more than 21,000 product liability claims over design defects associated with various different polyproylene products old in recent years, including the Bard Ventralight, Bard Ventralex, Bard Perfix Plug, Bard 3DMax, and other similar systems.

Since August 2018, the Bard hernia mesh lawsuits have been centralized as part of a federal MDL in the Southern District of Ohio, where the parties are currently engaged in global settlement negotiations to resolve claims. Similar proceedings have previously been pursued over problems with Ethicon Physiomesh, Atrium C-Qur and other mesh products linked to high failure rates.