FDA Investigating Counterfeit Material in Boston Scientific Transvaginal MeshApr 4, 2016
The FDA is examining these allegations to determine any necessary and appropriate actions. The agency said at this time it is not aware of any adverse health effects associated with the counterfeit materials.
According to the FDA, manufacturers sometimes change the source of a raw material in a device after the device has received FDA clearance and such a change often does not require FDA review. However, in light of the allegations of counterfeit material, Boston Scientific will conduct additional testing relevant to the safety and effectiveness of the finished product.
The additional testing should give the FDA to determine whether the surgical mesh manufactured from the alleged counterfeit raw material is equivalent to the surgical mesh manufactured from the original raw material. The testing is expected to take several months to complete. In the interim, the FDA believes that health care professionals and their patients should be aware of this investigation so that they can make the most informed health care decisions.
For women who have already been implanted with the Boston Scientific transvaginal mesh, the FDA is not recommending removal of the device. Available data do not suggest any reduced benefit from the device, and the additional risks associated with mesh removal outweigh any risk that may be associated with the use of mesh manufactured from alleged counterfeit raw material.
Boston Scientific has been sued under the Racketeering and Corrupt Organizations Act (RICO) for allegedly orchestrating a conspiracy to sell transvaginal mesh made from counterfeit plastic smuggled from China. In 2011, when the company began to encounter difficulties obtaining the material from its supplier, Chevron and Phillips/Sumika, the company allegedly began smuggling the material out of China. According to Qmed, Boston Scientific worked with a “known counterfeiter,” EMAI Plastic Raw Materials, and ultimately smuggled some 34,000 pounds of counterfeit material without verifying the contents.
Beyond concerns about counterfeit materials, transvaginal mesh devices are associated with injuries and side effects and are the subject of thousands of lawsuits against Boston Scientific and other makers. According to the FDA, common side effects associated with transvaginal mesh devices include:
- mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- pain during sexual intercourse
- organ perforation
- urinary problems
Many women need additional surgery to remove the mesh and repair damage. The FDA has proposed a reclassification of mesh devices from Class II to Class III. This would mean that mesh devices have to undergo a more stringent clearance process, including clinical trials, to determine if the devices are safe and effective.