Mesh Past and Present

Prolift, from Sumsuro, Japan

Mesh Medical Device News Desk, January 7, 2018 ~ So the MDL (multidistrict litigation) was established by the Judicial Panel on Multidistrict Litigation in Miami January 2012. Today there are more than 104,000 defective product, also known as product liability cases filed in the MDL federal court in Charleston, WV.

Here is a brief summary of where we are today.

Johnson & Johnson has the largest number of cases in the MDL, more than 39,000 recently, followed by Boston Scientific, more than 25,000, then AMS (American Medical Systems) more than 21,000, then C.R. Bard 16,000, followed by Coloplast, Cook and Neomedic.

You can go to Sodistrictofwv.com and pull up the most current numbers easily by clicking on the manufacturer and then on numerical list of cases. You can also put your name in the search bar to ull up your case and case number. You will need a Pacer account to read the complaint.

Cases are still being filed, for example, from August to November 2017 there were nearly 800 cases added. That’s because pelvic mesh is still being used.

In fact, the American Urogynecologic Society (AUGS) still calls incontinence mesh the “Gold Standard” and touts its use. That is difficult to believe since the majority of cases filed calling the implants defective, are for “slings” another word for incontinence mesh.

The larger mesh for pelvic organ prolapse (POP) has met a different fate. J&J took its Prolift off the market and most manufacturers quietly discontinued their POP meshes. They were causing devastating problems and are nearly impossible to remove.

In January 2016, the FDA decided to reclassify POP mesh as Class III or High Risk, which is probably where it should have been in the first place, not moderate risk. The FDA gave manufactures 30 months to prove the safety and efficacy or stop selling POP mesh. That takes us to the fall of 2019. The thought is that’s the end of POP mesh because it really can’t be proven problem free, even in the most experienced hands.

As you probably know, most medical devices do not go through the same scrutiny as drugs before cleared for sale. The FDA simply requires paperwork stating that the medical device is the “substantial equivalent” to one already in commerce. There are no requirements for clinical trials and years of study to prove safety and efficacy. In essence, the FDA is allowing the manufacturers to regulate themselves.

As the FDA found out in 2008 when it issued its first warning, there were thousands of complaints of injury being reported to the antiquated FDA site to register complaints- called the MAUDE database, which would scare away anyone. You need to know the regulatory language and most people find it unusable. Three years later, the FDA issued a second public health notification that complications were “not rare” reversing itself on the 2008 warning.

Other than that, the FDA did nothing except hold an expert panel in September 2011 that concluded POP mesh was a problem but slings were not. It took until 2016 for the FDA to reclassify POP mesh as high risk or Class III and even then, the agency gave manufacturers the benefit by allowing 30 months for the stuff to remain on the shelves and presumably used.

The Institute of Medicine, in a report, said the FDA clearance requiring only the Substantial equivalence test, is antiquated and should be abolished.

Trials have proven that the mesh is defective, that the warnings were inadequate and that the manufacturers violated their warranty and in some cases, state consumer laws.

We also have thousands of people in New Jersey, Bergen Co who are lined up for lawsuits naming CR Bard and Ethicon as well as cases in Los Angeles naming Boston Scientific and more than 100 in Philadelphia against defendant Ethicon and Boston Scientific.

Here is a list of the cases so far.

TVT-O from beckenbodenzentrummuenster.de

Meshes found defective in a court of law are still on the market and the predicate device remains, even when it is removed from the market.

It’s impossible to know how many people have died from mesh implants. Hernia mesh, made from the same polypropylene, is not looked at as a cause of death even when there is a colon nick and sepsis results. Look up hernia death in the FDA MAUDE database and you will see numerous reports of sepsis.

Often the infection finally undermines the immune system and kills a person. Again, mesh is not mentioned because no one is looking at that as a cause of death, not yet anyway.

UCLA Autoimmune Registry

UCLA is doing data gathering on autoimmune reactions to mesh, which it seems to incite in some people. The polypropylene mesh seems to hold onto bacterial contamination, incites a foreign body reaction and can create a biofilm colony using the mesh as a host. Many women report additional autoimmune complications to their pain of fibromyalgia, brain fog, rashes etc….

The MDL system has resulted in a few verdicts that are resulting in settlements by manufacturers, but the amount offered isgenerally very low and law firms are taking up to 40% of any settlement dollars. Some women are ultimately left with less than the law firm, after 40% and expenses are subtracted and she is loaded with liens and medical expenses.

Meshes found defective in a court of law are still on the market and the predicate device remains, even when it is removed from the market. ###