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Vaginal mesh is a device that thousands of women have had implanted to help with pelvic organ prolapse and stress incontinence. A manufacturer with millions in sales claims that the device is safe, but thousands of women are suing, saying that the device has left them with intractable pain and needing additional surgery to remove the mesh devices. WIVB 4 reports on the story.
More than 100,000 women are suing the manufacturers of a strip of plastic called gynecological mesh. One of these manufacturers, Boston Scientific, has attracted 48,000 lawsuits. The litigation against the various manufacturers of vaginal mesh might be the largest of its kind since those seen against asbestos.
Dr. Michael Margolis is a surgeon who removes mesh implants. He is a witness in the litigation against Boston Scientific, which claims that its devices are safe and have successfully treated a million women.
Dr. Michael Margolis disagrees. He says that the implants cause an inflammatory reaction. He also says that the devices he’s removed have shrunk in size by 50% from the time they were implanted. The implants that he’s removed have been encased in scar tissue. The porous openings in the mesh have shrunk considerably.
The mesh is made of a plastic called polypropylene which Boston Medical was receiving from a subsidiary of Chevron Phillips. However, among concerns about the use of polypropylene, which breaks down in oxygen, inside the human body, Chevron Phillips cut off Boston Scientific’s supply of the material, called Marlex.
When they could not find the material locally, the company decided to source the material internationally. Internal documents obtained reveal that Boston Scientific had doubts about the authenticity of the material they sourced in China. Documents also reveal that Boston Scientific checked through Chevron Phillips and confirmed that the Chinese shipping numbers were fraudulent.
Even the bags that the material was shipped in had errors, from the colors on the bag to misspelling the name of the city in Texas where the Marlex was supposedly made. Boston Scientific still continued to use the material in its mesh products, afraid that moving to a new material would require years of tests.
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