Mesh News Desk, February 26, 2016 ~Written by an anonymous woman in response to the story about Chinese mesh smuggled in by Boston Scientific from China.
Judge Goodwin has asked the Food and Drug Administration (FDA) to weigh in as to whether the mesh falls within the regulatory approval Boston Scientific received to sell its mesh products. The FDA also has the authority to see if the Chinese mesh contains selenium, a metal, or any other contaminants, as research obtained by the Mostyn law firm of Houston, Texas alleges.
Mostyn First Amended Complaint alleges RICO violations by Boston Scientific, filed Jan 29, 2016.
I am a mesh victim. I follow your site regularly and receive your newsletter. Like many victims, I hesitate to reply due to litigation, and wish to remain anonymous. However, I felt compelled to forward my opinion on the BSC (Boston Scientific) litigation hold.
By sending this case to the FDA for review, Judge Goodwin has given all of us a voice within the FDA. Records pertaining to device compliance, medical, product safety and manufacturing for these devices could potentially be reviewed. This is a good thing.
By including them in this process, Judge Goodwin has given the FDA the charge to identify any infractions and to potentially fully investigate BSC medical device compliance. In their role of federal oversight, any ramifications from raw material safety violations fall under their jurisdiction. It is the FDA that has the authority and the expertise for this review.
Will the FDA examine the supply chain and production processes for BSC? Will they review the supply chain and safety precautions implemented by other pelvic mesh producers? Unknown, but the process of completing their investigation would include a paper trail that could provide a clearer picture of the manufacturers regarding product safety and regulatory control.
Manufacturers are required to establish procedures that identify and track product components throught the manufacturing process and guarantee their safety. Non-compliance could result in an audit or other regulatory event. Compliance to FDA standards is paramount to the device system. The FDA has the authority to evaluate whether these devices were produced in compliance with GMP (good manufacturing practices) and proceed accordingly.
Under the FDA regulations for GMP, manufacturers are required to track raw material purchases, production lots, and finished product quality and consumer safety information for every device. They are required to maintain these records in accordance to FDA policies and procedures…legal hold or not.
I think Judge Goodwin has opened the door for direct oversight of the supply chain and manufacturing processes, establishing accountability from the defendants in these cases. State and Federal policy makers, insurers and other stakeholders will be able to review the outcomes of any procedural review undertaken by the FDA. Any review will be an additional source of oversight and compliance. The attorneys and advocates will have additional references to apply to their review of each case. These are all good things.
Below are links to some of the device regulations.
The following from the FDA website – www.fda.gov:
Regulations, guidances, and other information for regulated industry.