Citizen Petition Wants Recall of Bos Sci Surgical Mesh

A citizen petition sent to FDA this week asks the agency to issue a Class I recall of Boston Scientific's surgical mesh, alleging that it is made using Chinese counterfeit resin containing high levels of selenium. The petition quotes emails from company employees to support its claims and blasts FDA for what it calls "inaction."

Mostyn Law filed the petition on behalf of a lead patient plaintiff in a federal class action lawsuit against Boston Scientific. The petition asks FDA to announce an immediate Class I recall of Boston Scientific products it claims were made with the counterfeit material from China. The petitioners also want the agency to send warnings to customers, users, and patients of products allegedly made made with counterfeit resin, and to treat this situation like a 2010 Class I recall of counterfeit C.R. Bard surgical mesh.

The petitioners claim that after the U.S. supplier of Marlex, a type of propylene used to make Boston Scientific surgical mesh, declared in 2004 that the material was not fit for permanent use in the human body and stopped selling it for medical applications, Boston Scientific allegedly was able to source the material from a distributor before starting to run out in 2011. The petition authors claim that Boston Scientific "turned to a known Chinese counterfeiter to satisfy its Marlex needs" and include excerpts allegedly from company employees discussing the situation. In addition, the petition alleges that the company "smuggled" the counterfeit material out of China. This is a "change of material," the petition claims, and should require a new 510(k) application.

Boston Scientific denied the petition's claims in an April 1 public statement. That statement read, in part:

"Boston Scientific does not use 'counterfeit' or 'adulterated' materials in our medical devices. The company rejects the allegations in the petition to the Food and Drug Administration filed by a Texas-based law firm on March 31, 2016. Boston Scientific has a robust quality system and dedication to patient safety. We stand behind our products, the materials used in those products and our commitment to women's health. Boston Scientific mesh products provide relief to thousands of patients for painful and progressive medical conditions. These mesh devices are made with Marlex HGX-030-01, a polypropylene resin. Polypropylene resins like Marlex have been part of implantable medical devices for more than 50 years."

"The FDA needs to do its job and ban this outright. We've clearly documented the health risks," said attorney Amber Mostyn in a press release announcing the petition. "Acknowledging there is a problem is not enough. It's like a firefighter watching a building burn while warning us not to play with matches."

FDA has published a notice on its website about the issue. In it, the agency said it is aware of the allegations about counterfeit raw material and that Boston Scientific will be running safety and effectiveness tests:

"We are currently not aware that the alleged counterfeit raw material contributes to adverse events associated with these products. It is not uncommon for a firm, based on its own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA, and such a change often does not require FDA premarket review. However, in light of the allegations, Boston Scientific will conduct additional testing relevant to the safety and effectiveness of the finished product . . . We expect that this testing will take several months to complete."

FDA had not responded with further comment at presstime.

The petition asserts that employee emails support its allegations, quoting one employee email that reads in part, "For this material, we have lost all of the original paperwork so we can't prove that was legally imported in the country. and if we don't get rid of the original bags or the writing on the bags when we claim they are from China (we have to say they are from China since we don't have the original paperwork attached), if it is caught by custom, we will be in trouble. Therefore the shipper told me it is better to consider to re-pack all of them or find a way to get rid of all of the words/writing on the bags." According to the petition, another employee responded with, "We can over bag, but we should not open bags and repack." 

The petition also alleges that Boston Scientific knew there were major differences between the Chinese material and Marlex but used it anyway. In addition, the petition claims that the Chinese material had high levels of selenium, which is toxic and if converted into selenic acid with hydrogen peroxide exposure, can speed mesh degradation and damage tissue and nerves.

In its statement, Boston Scientific explained, "Changing suppliers of raw materials is not unusual for medical device companies, and when Boston Scientific makes such a change, we follow the processes required by our quality system. In 2011, we located a new supplier of Marlex resin. Upon doing so, we put samples of the resin through a rigorous battery of tests to demonstrate equivalency. In addition, we conducted extensive mechanical tests to ensure our mesh products manufactured with the newly sourced material met product specifications."

Mostyn also made these allegations when it filed a federal racketeering lawsuit against Boston Scientific and three other companies in January. "Because the FDA has primary jurisidiction over the safety of medical devices and authority to issue recalls, the judge in that case has suspended legal action to give the regulatory agency time to act," the press release announcing the petition this week explained.

Boston Scientific's statement concluded, "We have the highest confidence in the safety of our mesh devices. We have shared our test data with the Food and Drug Administration (FDA), and are fully cooperating with the agency's requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests. In the interim, we encourage physicians to continue to have confidence in our products and make the best, informed decisions with their patients."

[Image courtesy of IDEA GO/FREEDIGITALPHOTOS.NET]