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FDA’s Approval of Anti-Scarring Device for Children Is Another in Long Line of Questionable Decisions

March 9, 2009

FDA’s Approval of Anti-Scarring Device for Children Is Another in Long Line of Questionable Decisions

Statement of Peter Lurie, M.D., M.P.H., Deputy Director, Public Citizen’s Health Research Group

Friday’s approval of SyntheMed’s REPEL-CV, which is designed to reduce post-surgical scarring in children following open-heart surgery, once again demonstrates the Food and Drug Administration’s (FDA) low standard for approving medical devices. On the heels of the FDA’s approval of ReGen’s Menaflex implant, this approval further shows the agency’s willingness to approve a device that has failed to demonstrate any clinical benefit.

In a clinical trial, this device demonstrated, at best, a modest decrease in the severity of scarring, which can complicate subsequent heart surgeries; it had no impact on the fraction of patients who had scars nor on the percentage of the operative area that had scarring. Even this “benefit” depended on the use of a rating that has never been validated. In addition, because remnants of the REPEL-CV implant were seen in 34 percent of patients in the REPEL-CV group, researchers may have known which patients had used the device, possibly biasing the results in the direction of apparent device effectiveness.

Given that the apparent purpose of preventing scarring is the facilitation of follow-up surgeries, it would be reasonable to expect the device to lessen the time it takes for surgeons to break up scar tissue. However, the trial did not show that the REPEL-CV made a difference. The lack of a positive result calls into question the usefulness of the device.

In the trial, there were also signs of possible dangers associated with REPEL-CV, including trends toward higher risks of death and chest infection. These differences were not statistically significant, but the consistent direction of the adverse effects observed, even if non-significant, is concerning. Because the trial was so small, we can only be assured that there was not more than a three-fold increase in mortality and not more than a 10-fold increase in chest infections for patients implanted with the device. This is hardly reassuring.

The approval of REPEL-CV bears an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. That trial was also underpowered for safety and showed a consistent but non-statistically significant increase in infection rates. Less than two years after Intergel was approved, the company removed the product from the market due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it. This history should have given the FDA pause before once again approving a similar device with a questionable safety record.

Dr. Daniel Schultz, director of the FDA’s medical device center, described the approval as “an example of FDA’s commitment to work with regulated industry.” The approval of REPEL-CV is more appropriately characterized as the latest in a string of ineffective devices approved by the FDA, including vagus nerve stimulation, transcranial magnetic stimulation and the Menaflex collagen scaffold. The public has a reasonable expectation that only safe and effective devices will come to market. Yet again, these expectations have been dashed.

READ Public Citizen’s December 2007 letter to the FDA.