Mesh Medical Device News Desk, July 22, 2019 ~  This is a story that is re-printed occasionally because there are newly diagnosed women with incontinence who are being told that a polypropylene mesh is their only answer to treat incontinence.

Doctors are selling patients by easing their concerns, selling them on a “new mesh” which simply is not true!!  So here are some questions to ask to make sure you are not sold on a treatment that has a potential to cause problems for the rest of your life, as you can clearly see on the pages of Mesh News Desk and on its Facebook page and group!

Image: JanUrban

You do have options!  

 

NEW MESH OR NEW NARRATIVE?

Dr. Duane Priddy, plastics expert on 60 Minutes

By now, most people have heard that there are a high number of product liability lawsuits filed against mesh manufacturers.  Johnson & Johnson and its Ethicon division, Boston Scientific, C.R. Bard, American Medical Systems, Coloplast, Cook Medical and Neomedic are the focus of more than 107,000 cases filed in one federal court in West Virginia.

Those lucky enough to go to trial are seeing verdicts that range from $1 million to $100 million, while the settlements pale in comparison (around $40k on average).

A recent 60 Minutes story on Boston Scientific and its shady methods to secure new raw polypropylene put a dark stain on the company and caused industry-wide reaction. Generally that comes in the form of hiring public relations professionals to “craft” a new narrative and issue “Talking Points” to quiet the public concerns.

Though MND has not yet seen those talking points (please sent them) this is the MO of corporate crisis counseling. Regardless, women are reporting they are being told that the mesh today is “New Mesh” and not that same stuff the lawsuits are about.

There have been too many report to disregard this as random narrative and not corporate re-branding.  So if you have stress urinary incontinence(SUI), urge incontinence, pelvic organ prolapse (POP) or a hernia, and your doctor is suggesting mesh:

WHAT DO YOU ASK?

Advantage Fit sling

While its true the major mesh manufacturers are playing around with the weight of the mesh and the pore size, basically most mesh is still made of polypropylene (PP) a cheap plastic woven from raw PP resin.  So some suggested questions you might want to ask your doctor. Make sure he/she answers the questions. Yes, you will have to question your doctor, but as many have found out the hard way, better to do it before rather than afterward.

  • What is the mesh you use made of?

    Answer: polypropylene, biologic or composite or coated is what’s on the market. Even biologic ( pig, cow or cadaver) or coated generally merge with a PP base. If your doc says its “Marlex”  or Prolene”  or Gynemesh, it’s all polypropylene!  Make sure they don’t pull that one on you. Ask to see the package. It’s possible your doctor doesn’t even know what mesh is made of. Many doctors do not understand the 510(k) clearance process by the FDA does not require clinical trials.  Please do not let them tell you its “FDA approved.”  That is simply NOT true!

  • How is it new?

    Uphold LITE, pore size 2.8 mm

    Answer: He/She may say its entirely different, get an answer – How is it new? Your doctor may be following the guidance of medical societies that favor using mesh as a first-line defense. Again he/she may have no idea how it is new. Mesh News Desk has heard of far too many women being told that, so there are talking points circulating in industry to try and continue the use of mesh.  Please don’t be fooled!

  • Is it polypropylene?

    Answer: Pay attention to this answer. Your medical provider may not even know, though he/she should know. PP is a polymer plastic sourced from the petroleum industry. It is also used for Tic Tac box tops and indoor outdoor carpet.

  • What is the brand name of the product you use?  Who makes it?  How long have you been using it? 

    Answer: See how honest and up front the provider is. Why does he/she use mesh from that manufacturer?  How is it different from other pelvic meshes? Is it made of polypropylene? What is the complication rate?  That’s telling because no one is tracking the complication rate which can range up to 30% of mesh used.  See this article.

  • Are there any alternatives to using mesh?

    Dr. Una Lee, Virginia Mason, Seattle

    Answer: Unless you have had a mesh repair previously and it has failed, unless you are obese and a smoker, there are generally alternatives to use polypropylene mesh. We’ve learned from litigation that it may not be the best choice for a first line defense against SUI and POP.  Please see this article from an experienced urogynecologist about alternative procedures to using mesh.

  • Am I a candidate for a non-mesh repair?

    Answer: This is important. Many newer doctors have not been trained in doing anything but using mesh to treat SUI and POP.  Ask if they can do a suture only repair. Does their education come from industry-supported seminars alone?

  • Can you do a native tissue repair?

    Harvested fascia lata

    Answer: This involves harvesting fascia from your body and using it as a “sling” so your body does not reject it.  This also involves more surgical skill and takes longer and ultimately may not be as profitable for your provider as a 20 minute sling procedure.   If your doctor cannot do this type of repair, why not? Isn’t going conservatively the best way to start? Does he understand the most experienced docs are not using mesh for slings?

  • How many native tissue repairs have you done?

    Answer: Will you become an experiment? You want to chose a provider who understands this method and agrees to go conservatively.

  • If needed, can you remove my mesh if it causes complications?

    Answer: Pay careful attention here, even the best doctors have trouble removing the arms or anchors that are punctured deep into ligaments, leaving behind lasting pain potentially.  If a doctor says he can, ask “How do you know?”

  • What is your relationship with the mesh manufacturer?

    Answer:  Look up Dollars for Doctors prior to your appointment.  A database from ProPublica, it has documented the financial relationship between doctors and the manufacturers and might be one factor you want to consider.  Can a doctor who has received $1 million from Ethicon be providing unbiased information about Ethicon mesh?  You decide.

    Other doctors have been known to be the inventor of a particular mesh product, yet have failed to reveal that to their patients. Is that true informed consent?

Creative Commons

If your doctor hasn’t thrown you out of the office by now, you may have found a good one who is willing to have a true partnership with his/her patient.

Good for you for becoming an informed consumer!

LEARN MORE ABOUT MESH PROBLEMS: 

Dollars for Doctors, ProPublica Database 

Mesh News Desk, January 2017, Polyproylene Resin Not Meant for Human Implants

Mesh News Desk, September 2016, AUGS Defends Polypropylene Mid-Urethral Mesh Slings

Mesh News Desk, April 2016, Dr. Raz Tells Docs Why He will Not Use Synthetic Mesh Slings

Mesh News Desk, July 2016, Questions to Ask Your Pelvic Mesh Removal Doctor 

Mesh News Desk, August 2015. Dr. Walker Answers Your Questions About Pelvic Mesh Injury

Mesh News Desk, September 2017, Dr. Bendavid Answers Hernia Questions 

Mesh News Desk, July 2016, What You May Want to know About Your Doctor’