Mesh Medical Device News Desk, June 6, 2016 ~
On October 27, 2014, Teresa Stevens was preparing for a scheduled hysterectomy when, at the suggestion of her doctor, she agreed to have a Boston Scientific Obtryx Halo vaginal mesh implanted into her body, like thousands of American women do each year. The problems started immediately.
“When I came out of surgery, my bladder wasn’t completely evacuating and I told my doctor I couldn’t feel my bladder,” the 46-year-old West Virginian said. “In almost two years since my surgery, I’ve regained no sensation.”
Today Stevens says she cries a lot. Stevens says her symptoms worsened—including frequent urinary tract infections, shooting pains in her abdomen and painful sex—she started growing more despondent by the day until, just a few months after her surgery, she decided to do something about it.
“I was at home one day and a commercial came on about problems caused by vaginal mesh, so I called the listed number for the law firm. They let me know about the problems surrounding the mesh, explaining that certain providers may have used a counterfeit product to create the medical device,” Stevens said. “I had a UTI at the time and I was hurting. I started crying when I found out that counterfeit mesh is possibly inside me.”
For Stevens, that one call revealed a wealth of knowledge about vaginal mesh and led her to file a lawsuit against Boston Scientific, the company that made her mesh implant.
Thousands of lawsuits have been filed against the company, but Stevens and her attorneys—Steve and Amber Mostyn of Mostyn Law and Harry Bell of Harry F. Bell Law in Charleston—allege that after losing their main mesh supplier, Boston Scientific panicked and decided to go outside the U.S. to China to source then smuggle into the U.S. thousands of pounds of potentially counterfeit mesh from China, that has been untested and non-FDA approved.
The discovery potentially could upset the company's $120 million a year pelvic mesh revenue stream.
Obtryx Halo patent
“It really upsets me thinking about what’s actually in me, because I don’t know if it came from China, if it’s counterfeit and what kind of chemicals are in there,” Stevens said. “I have no idea what’s going on in my body and I don’t know where these pains and infections are coming from.”
Harry Bell Law, Charleston, WV
As for having the mesh removed, pelvic mesh is intended to be a permanent implant. Finding one of the few who specialize in mesh complications is another obstacle. First of all is it safe or will an explant procedure potentially do more harm.
Then there is the question of insurance, even if she can find a specialist. “Who even knows if my insurance will pay for it?”
Boston Scientific uses its Advantage mesh made of its proprietary Marlex polypropylene mesh. It claims to have implanted 500,000 women and to this day claims the mesh is biocompatible.
Billed as a minimally invasive procedure, there are 93,000 lawsuits consolidated in Charleston, WV naming seven mesh makers, Boston Scientific among them, in product liability lawsuits. Stevens has filed an action that alleges racketeering in bringing the mesh to the U.S. and fraud in its marketing. Here is her RICO action.
Obtryx halo introducer
Since Steven's class action lawsuit was filed earlier this year, progress has been made: A grand jury has convened in Charleston, W.Va, and sent out subpoenas for documents regarding Boston Scientific’s purchase of the materials.
Mostyn Law has also called on the FDA to further investigate the potentially counterfeit material from China to see if it’s equivalent to FDA-approved Marlex, or a specific type of polypropylene that is cleared by the FDA for use under its abbreviated 510(k) approval process.
The firm also asserts that even if the mesh is compliant with FDA standards, Boston Scientific has still violated counterfeiting laws by smuggling in the Chinese mesh.
Stevens hopes that by bringing her case to the forefront of the conversation she’ll be able to protect other women from enduring a similar fate. Boston Scientific mesh allegedly made from the counterfeit raw material from China is still being used and implanted in women suffering from prolapse and incontinence.
“So many women with vaginal mesh have this uncertainty of ‘what’s in me.' ” Honestly, I don’t think that doctors should put mesh in anybody, but especially not counterfeit mesh,” she said. “Would these doctors recommend vaginal mesh to their own mother or sister without knowing what’s exactly in it? I don’t think they would.” #