Boston Scientific is finally facing greater heat over allegations that it used substandard material in its vaginal mesh implants. Federal prosecutors have impaneled a grand jury in Charleston, West Virginia as Boston Scientific faces criminal investigation over counterfeit mesh. It’s about time! The affected mesh has been implanted into thousands of women across the U.S.
Boston Scientific is finally facing greater heat over allegations that it used substandard material in its vaginal mesh implants. Federal prosecutors have impaneled a grand jury in Charleston, West Virginia as Boston Scientific faces criminal investigation over counterfeit mesh. It’s about time! The affected mesh has been implanted into thousands of women across the U.S.
Several subpoenas have been sent out over the last few months. The grand jury is not empowered to determine BS’ guilt or innocence; its purpose is merely to compel the production of evidence, whether documents or testimony, such that it can decide whether pressing criminal charges is appropriate. If one was an executive at BS right now, one would be sweating bullets.
The information about the subpoenas comes from two sources, speaking anonymously as they weren’t authorized to discuss the probe. One of the subpoenas was obtained by the Boston Globe. That subpoena demands BS produce documents regarding the company’s purchase of certain synthetic resin used to manufacture the mesh implants.
One of the anonymous sources also said that federal investigators are attempting to determine if BS employed deceptive trade practices in the purchase of the counterfeit mesh. Specifically, the question is whether the company knew it was buying substandard Chinese resins that were put in packaging from another, U.S.-approved, vendor. Further, the investigation seeks to determine if BS knowingly and fraudulently sold the substandard, defective mesh devices to healthcare providers.
Boston Scientific spokesperson Kelly Leadem said that the company voluntarily provided the Department of Justice with the requested documents. However, she said, the company has not yet been subpoenaed.
Transvaginal mesh devices are commonly used to repair a condition known as pelvic organ prolapse or POP. The condition occurs when the bladder drops from the lower abdomen and presses against the vaginal walls. However, mesh devices have been linked to several other, more serious, health problems.
Among the new health problems created by the devices are infections, bleeding, severe pain & discomfort, urinary issues and painful intercourse. Affected women have taken to social media campaigning for the removal of the devices from the market. There are also thousands of product liability suits against BS and other mesh manufacturers.
The cases have been consolidated into a multidistrict litigation (MDL) being overseen by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.
The issue of counterfeit resins became public in January after Houston-based Mostyn Law filed suit against Boston Scientific claiming that BS basically ran and “international conspiracy” as well as a racketeering scheme to fraudulently sell substandard, defective mesh.
The Mostyn suit claims that Boston Scientific lost its U.S. resin supplier, at which point it sought out a known Chinese counterfeiter. The suit further claims that BS was “acting like a drug dealer” by hiding roughly 33,000 pounds of the bogus resin shipments from U.S. and Chinese customs agents by putting it in packaging from a federally-approved vendor.
BS’ CFO, Daniel J. Brennan, mentioned the Mostyn suit in a February 4 conference call with stock analysts. He said BS had given the FDA, the DOJ and health & safety regulators in Europe, all of the information they requested. However, he did not mention the federal investigation or the grand jury.
Then, in a February 24 regulatory filing, BS stated that the U.S. Attorney’s Office in West Virginia was checking into the counterfeit resin claims. To date, federal prosecutors have not accused Boston Scientific of doing anything wrong.
An email statement from Ms. Leadem said, “Boston Scientific does not use ‘counterfeit’ or ‘adulterated’ materials in our medical devices. 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.”
However, BS is now working with the FDA testing the safety and efficacy of its mesh devices in an effort that is expected to go on for a few more months. An effort, by the way, that has drawn much criticism given the fact that BS has a motivated self-interest in showing the products are safe.
The FDA issued a safety alert on April 1 stating that the agency was investigating claims of substandard materials in BS’ urogynecologic surgical mesh products. The agency didn’t go so far as to suggest that women get the devices removed, though. Instead, the FDA said that it didn’t know of any safety issues specifically caused by the counterfeit resin. It further noted that “available data do not suggest any decreased benefit associated with the device.”
This investigation is good news for the thousands of women whose health has been all but destroyed by pelvic mesh products. While different from the civil suits over injuries caused by the mesh in general, criminal charges (and especially a conviction) could strongly bolster the civil cases by showing Boston Scientific’s utter disregard for patient safety.Source:
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