Investigators claim that an untold number of patients were put directly at risk by Boston Scientific Corporation’s unsavory business practices. The Food and Drug Administration is currently leading the main investigation into the resin that the company used to make its surgical vaginal mesh product. Female patients all across the United States — including in Ohio — were seriously injured because the resin used in the mesh was actually counterfeit.
Current legal action against Boston Scientific has been halted while the FDA pursues its investigation, although all of the claims still stand and have not been dismissed. It is up to the FDA to determine the safety and efficacy of other products produced by the company. The serious safety concern stems from the shocking discovery that Boston Scientific deliberately smuggled counterfeit resin out of China. The company’s supplier based in the United States warned Boston Scientific that plastic resin was unsuitable for internal use and refused to continue selling the substance.
Boston Scientific apparently never verified the substance’s identity nor did it perform any necessary testing despite internal evidence that the company was concerned about the quality in as far back as 2011. In the intervening period of time, claims began to pour into both the company and the FDA that the vaginal mesh was causing serious and permanent injuries. At that point, it continued to hide its actions.
The results of the investigation by the Food and Drug Administration could possibly turn up further evidence of irresponsible actions and misconduct within the company in concern to consumer safety. Ohio patients who have experienced severe and adverse reactions to Boston Scientific’s vaginal mesh products can potentially utilize the evidence uncovered by the FDA to support their own claims. While of course no amount of money could ever undo or erase the injustice inflicted by a purposely negligent company, the resulting recourse can be put towards necessary and related medical care.
Source: setexasrecord.com, “Mostyn Law calls on FDA, Boston Scientific to stop the use of counterfeit surgical mesh“, David Yates, Jan. 29, 2016