Public Citizen Calls for Removal of FDA Approval of Surgery Aid
A medical device that has been on the market for almost 20 years is dangerous, according to a recent petition.
Public Citizen, a nonprofit consumer rights advocacy group out of Washington, D.C., filed a petition to the Food and Drug Administration (FDA) claiming that Seprafilm should be removed from the market.
Seprafilm, created by biotechnology company Genzyme, is a thin sheet of gel-like materials utilized by surgeons to prevent internal organs from forming fibrous bands of tissue.
Public Citizen claims that the clinical studies the FDA used to issue an approval in 1996 were filled with problems. Additionally, a required study performed after Seprafilm went to market used questionable forms of analysis and failed to establish the product's effectiveness.
Through information found in an FDA database, Public Citizen discovered 524 reports of adverse reactions to Seprafilm, as well as 21 deaths.
This is not the first time the product has resulted in issues for Genzyme. In 2013, the company paid over $22 million to resolve allegations that sales representatives marketed Seprafilm for inappropriate use.