Plastic fantastic or not, its your choice

I’d choose titanium over plastic any day if I had a choice for surgical reconstruction or organ support.

Unfortunately, New Zealand women who need bladder or gynaecological repair work don’t get that choice. There are very few options available for treating pelvic floor disorders, so we get plastic mesh.

Surgical Mesh Stock Photo Getty Images

Over the years there have been unwelcome complications from the surgery and allegations of dodgy plastic mesh from one supplier of surgical mesh, Boston Scientific. ?Boston Scientific polypropylene-based (plastic) devices have been a mainstay in many medical procedures for more than 50 years, including hernia and tendon repair, sutures, and wound closure.

A? New Zealand website, Mesh Down Under, has gruesome stories of women with horrible complications from surgery using plastic mesh. It is enough to put anyone off before even looking at the number of ACC claims made. Quote

So far, at least 800 injury claims associated with the products have been lodged with ACC. Injury payouts have cost about $13 million. End of quote.

These 800 claims all relate to the use of surgical mesh but some claims will be the result of dodgy surgery. Of those 800 claims, only five can be identified as mesh supplied by Boston Scientific, as of two years ago.? We do not know if these claims are as a result of product malfunction or surgical error, so can surmise that the Boston Scientific product in New Zealand is relatively safe to use.

Two years ago our health watchdog Medsafe investigated Boston Scientific’s mesh products and cleared the products reporting finding five adverse event reports on its use:? Quote

?Boston Scientific?s response provided comprehensive information about the testing of the polypropylene material that had been used to make mesh the company had distributed,? spokesman Chris James says. Information included physical and chemical testing which was aimed at ensuring the material met or exceeded the specifications of previous batches of material and that it was safe to use.
In total, five adverse event reports involving Boston Scientific mesh products have been logged with Medsafe”.? End of quote.

‘Made in China’ is probably not a label you want to see on the plastic product that is going into your body, and allegations that Boston Scientific illegally sourced inferior resin from China after their main supplier pulled out have been strongly refuted by the company. Quote

The investigative story contained “completely false claims that our transvaginal mesh products contain counterfeited and smuggled materials,” according to the company’s statement, which is signed by?CEO Mike Mahoney, and Dave Pierce, president of Boston Scientific’s urology and pelvic health division. End of quote.

It is also alleged that Boston purchased 30 years supply of the Chinese resin giving them enough product to last until 2035. This argument only holds up if Boston uses the resin solely for its surgical mesh production but they produce many other surgical products. Surgical mesh comprises just 1% of Boston products which they say they will continue to produce because it is one of the few options available to treat pelvic floor disorders.

That there can be serious complications from using plastic mesh is indisputable, but the use of mesh made from Chinese resin or not, is polypropylene implanted permanently in the human body such a good idea?? Boston’s previous supplier of the Marlex product, Phillips Sumika, stopped supplying it in 2005 and issued a statement in 2008 saying it was not:? Quote

?Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues?.? End of quote.

However, the FDA (United States Food and Drug Administration) disagrees. It investigated Boston Scientific’s Urogynecologic Surgical Mesh Implants, including the raw materials and released a report last year which cleared the Chinese resin and vindicated the company: Quote

The FDA determines the safety and effectiveness of finished products, not raw materials. However, in this case, to thoroughly address the allegations, we reviewed testing of the polypropylene raw material, as well as the finished mesh manufactured with polypropylene resin from both sources.

We found variability between the polypropylene resin from both suppliers, but determined, based on the information available to us, that these differences do not present new safety or effectiveness concerns, and do not require submission of a new premarket notification. Our previous update on the issue is available online.? End of quote.

The reasons why plastic mesh can cause problems are that polypropylene can cause inflammation, also it is unstable because it breaks down in contact with oxygen, making it shrink as much as 50%.? The body’s reaction to the mesh is to encase it in scar tissue, which can be uncomfortable and difficult to remove but can also provide support to replace the weakened tissue.

You have to ask the question, after Boston’s mesh products were cleared by the FDA and Medsafe last year, and it is nearly ten years since the resin was sourced from China, why 60 Minutes ran with this story? The answer to that question might be in who benefits from it, because it is not obvious at this point and?it certainly isn’t Boston Scientific who have been unfairly slated.

As in all things, there are choices involved here, and decisions made on whether the risk of plastic mesh surgery going wrong is preferable to a lifetime of incontinence pads.

One in three women globally is affected by pelvic floor disorder, not all severely.? But if the risk of plastic mesh is enough to put the wind up you, ladies, there is a very good argument for keeping up those pelvic floor exercises.