Adhesion Prevention: Safety Before Cost

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Excerpt

To the Editor:
Although the attempt by ten Broek et al1 to provide a comprehensive review is appreciated, it overlooks recent studies that raise questions regarding the safety and efficacy of one of the most widely used adhesion barriers covered in this review—hyaluronate carboxymethylcellulose (Seprafilm, Sanofi, Paris, France).
A 14-year retrospective study at the Cleveland Clinic coauthored by Dr Fazio, a lead investigator and coauthor of the pivotal safety and efficacy studies for hyaluronate carboxymethylcellulose (HA-CMC), found use of HA-CMC in restorative proctocolectomy significantly associated with pelvic sepsis.2 The study was reported by the manufacturer to the Food and Drug Administration adverse event database.3 Another 10-year retrospective study found a significant increase in postoperative abscess formation and bowel complications.4
One study found unexplained fluid collections when used in gynecologic debulking surgeries.5
Another found placing HA-CMC at primary cesarean delivery was not associated with decreased time to delivery, total operative time, or complications during repeat cesarean deliveries.6 As these were all done at major research centers, one would expect this comprehensive review to have mentioned at least one of these studies.
The problem of isolating the safety and efficacy data for patients with preexisting adhesions where barriers have been placed is not addressed. The concern is important given that surgeons have noted adhesion barriers are used primarily during relaparotomy.7 Such use in the Fazio et al8 study resulted in a higher incidence of recurrent obstruction in the HA-CMC group (17%) vs the control (10%). Although the result was nonsignificant due to sample size, it can raise concern over HA-CMC use in the presence of preexisting adhesions. Indeed, 2 of the authors of this review (RPGtB, HvG) have suggested elsewhere that use of adhesion barriers during repeat operations and after adhesiolysis may be less effective than primary prevention.9 In a study by Vrijland et al,10 in which there was no reduction of the incidence of adhesions, they postulated “the relatively high incidence of preexisting adhesions could explain the absence of reduction of adhesion formation in the Seprafilm group.”
Given the narrative nature of this review such concerns might be overlooked, but not when patient safety is at stake. In the last 10 years of the product's 20-year use, there are over 400 serious adverse events including deaths associated with HA-CMC in the Food and Drug Administration adverse event searchable database,3 and although this review makes a thoughtful economic argument, it could have explored the safety issue more thoroughly.
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