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60 Minutes investigates transvaginal mesh used in thousands of women
by Mandy Hicks
By Jessica Surber, Partner
English, Lucas, Priest & Owsley, LLP
Women seeking relief from a variety of issues, including incontinence and other problems after child birth, sometimes receive a mesh implant made by a variety of companies including Boston Scientific. The mesh often ends up causing more problems than it solves.
60 Minutes recently outlined exactly why there are so many lawsuits against Boston Scientific concerning this transvaginal mesh. Boston Scientific refused to speak to 60 Minutes and says that any allegations made against them are are false.
More than 48,000 cases have been filed against the company, with nearly 100,000 women seeking relief, making this one of the the largest MDLs (multidistrict litigation) in recent history.
60 Minutes sifted through the massive court files and gave a compelling and shocking report. We recommend watching the segment regarding these mesh failures. It is titled “The device that has 100,000 women suing” and can be found in Season 50, episode 35.
Here is an outline of the story and what exactly went wrong with the transvaginal mesh products.
Transvaginal mesh: 2004 to present
Boston Scientific makes a version of the mesh at issue that is implanted in women. The mesh they were using in the early 2000s was made of polypropylene (plastic) which was made by Chevron Phillips and called Marlex. In 2004, Chevron Phillips issued a warning that Marlex should not be implanted in the human body. Chevron Phillips refused to sell Marlex to Boston Scientific any longer for medical uses. E-mails that have become part of the court record in these cases indicate that Boston Scientific executives pushed to continue to get the Marlex from Chevron Phillips, but Chevron Phillips refused.
The company wanted Marlex because it was approved by the U.S. Food and Drug Administration. Switching products would mean Boston Scientific would have to go through another FDA approval process.
Boston Scientific began seeking other places to get Marlex, and found a broker in China that indicated it could provide lots of Marlex – literally tons – for Boston Scientific. The company tried to determine if the Marlex was legitimate. Chevron Phillips said the lot numbers were fake, the name of the city in Texas where it was manufactured was incorrect on the packaging and even the logo colors for the Marlex were wrong. For these reasons, it did not appear to be genuine Marlex product. Boston Scientific executives decided to have it tested to see if it had the same composition as the Marlex they had been using. Tests revealed that it had different characteristics, but the company bought it anyway and began using it.
To see if Boston Scientific was still using the Marlex that came from China, 60 Minutes purchased 15 mesh kits and had those sent to a respected plastics lab, and the lab said it matched the Chinese plastic that was supposed to be Marlex. This research indicated that even though the company has been sued by 100,000 women, it is still using questionable (at best) materials.
Patients’ experience with Boston Scientific mesh
Our clients have experienced a wide range of medical issues similar to those experienced by the many women interviewed for the story.
These women indicated that after their surgery they felt as if there was “sandpaper” or a “cheese grater” inside them. It was painful just to walk. One mother said she could no longer play with her kids because of the pain. Another woman said she knew something was wrong before she even left the hospital. The mesh was painful and she could no longer feel when she needed to urinate.
60 Minutes interviewed a surgeon, Dr. Michael Margolis, who has removed about 350 of these transvaginal mesh products from patients. In many cases, the implant shrunk more than 50 percent, and was encased in scar tissue. A scientist interviewed for the story, Dr. Duane Priddy, said polypropylene is not stable enough to be implanted in the human body permanently. “I can’t in my wildest imagination imagine anybody that is knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body,” Priddy said during the 60 Minutes interview. “It’s well known that it is oxidatively unstable.”
What to do if you have a transvaginal mesh
First, you should consult your doctor if you’re experiencing any pain in the pelvic area that you believe might be related to the implanted transvaginal mesh. You may need to have the mesh removed. Discuss this with your physician as soon as you begin having problems. Safeguarding your health should be your highest priority.
Second, consider speaking with an attorney. If you believe you may be suffering the ill effects from a failed transvaginal mesh implant, you need to act soon. For a free consultation to determine if you may have a case, contact attorney Jessica Surber at (270) 781-6500 or jrsurber@elpolaw.com.
