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Teresa Stevens Speaks Out About How She Got Involved in Boston Scientific Lawsuit Over Counterfeit Transvaginal Mesh
Jun 7, 2016 | Mesh Medical Device News Desk
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. -
Where is the FDA on Pelvic Mesh Today?
Jun 7, 2016 | Mesh Medical Device News Desk
The FDA has been slow to act and react to mesh complications.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Jun 7, 2016 | Mesh Medical Device News Desk
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.
“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 fordocuments 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.”
http://www.meshmedicaldevicenewsdesk.com/teresa-stevens-speaks-got-involved-boston-scientific-lawsuit-counterfeit-transvaginal-mesh/
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Where is the FDA on Pelvic Mesh Today?
Jun 7, 2016 | Mesh Medical Device News Desk
The FDA has been slow to act and react to mesh complications.
Be sure to make your report to the agency so it has the ammunition it needs to act.
The first warning came from the U.S. Food and Drug Administration (FDA) in 2008. The watchdog agency issued a The Public Health Notification (here) after it had received numerous complaints from women who were implanted with polypropylene pelvic mesh to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
The first FDA Safety Communication said mesh complications are “rare” and include mesh exposure through the vagina, pain infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems as well as recurrent prolapse, nerve and muscle problems, vaginal scarring and shrinkage and emotional problems as a result.
This report was issued after the FDA received over 1,000 adverse event reports.
But by January 2008 through the end of 2010, the number of injury complaints increased three fold.“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” said the agency.
What was significant was by July 13, 2011, the FDA had amassed so many complaints that the agency reversed its warning.
In FDA UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, this second notice said complications associated with mesh used for POP repair are “not rare” (here).
The FDA, in its second warning, identified mesh used for POP repairs a particular culprit and one that “introduces risks not present in traditional non-mesh surgery for POP repair.”
Earlier this year, the FDA moved (here) to reclassify POP mesh, the larger polypropylene mesh used to shore up a sagging uterus or colon as a higher risk Class III. It gave mesh manufacturers 30 months to prove their mesh is safe or take it off the market. In the meantime it can still be used. See the background story here.
The FDA, in its second warning, identified mesh used for POP repairs a particular culprit and one that “introduces risks not present in traditional non-mesh surgery for POP repair.”
Earlier this year, the FDA moved (here) to reclassify POP mesh, the larger polypropylene mesh used to shore up a sagging uterus or colon as a higher risk Class III. It gave mesh manufacturers 30 months to prove their mesh is safe or take it off the market. In the meantime it can still be used. See the background story here.
WHY IT’S IMPORTANT TO REPORT AN ADVERSE EVENT TO THE FDA
So how do you report to let the FDA know you are not alone? The only way the agency can act is if it knows bout your report and it sees complaints trending upward. So reporting ANY mesh complications, transvaginal, abdominal and hernia mesh, is very important.
When Scottish mesh survivors spoke to a parliamentary committee, they got changes imposed. As far as the report your doctor submits, please check it for accuracy. Sometimes the conclusion written is inconclusive after it has passed through a rewrite. Please check the report your doctor submits to make sure it reflects your true story. You can also report on your own.
If your lawyer reports the event, it may not be taken as seriously as we saw when the FDA calculated reports on trocars to consider reclassifying them. See background storyhere.
You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:By phone- 1-800-FDA-1088By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
MedWatch Online Voluntary Reporting Form (3500) is here.
Or you or your doctor could report directly to theManufacturer and User Facility Device Experience (MAUDE)database on medical devices that have caused injury.
Here is the database:
The FDA’s MAUDE database is not easy to figure out. You would not call it user friendly. You will need your medical records to find:Manufacturer’s nameProduct name (brand name)Catalog numberLot numberSizeDate of implantDate of explant (if mesh was removed)Details of the adverse event and medical and/or surgical interventions (if required)Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)Surgical approach: (e.g., vaginal, abdominal, laparoscopic)Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Here is what one woman entered into MAUDE for her pelvic mesh implant injury.
1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.One telling factor is that the FDA says it takes the “least burdensome approach to regulating.” That’s right! The “least burdensome” on the manufacturers, not on you, the end recipient of the devices they oversee. Here is the language from the FDA:The Least Burdensome Approach
“We consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance document.” Read about Least Burdensome on the FDA website here.
http://www.meshmedicaldevicenewsdesk.com/fda-pelvic-mesh-today/
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