ALL MESHED UP which premiered at the New York Socially Relevant Film Festival in March 2016 is one of the best documentaries I have seen over the last year. Produced the Netherlands it is a data driven investigation revealing through its analysis of vaginal mesh implants the problems of more than 500 000 medical implant devices marketed and sold in the European community. There are no procedures establishing the safety of these devices or of the liability of companies selling them. All that is needed is a CE certificate for sales as it is for toothbrushes, teddy bears and hair driers. For this certification which must be attached to the product on a per item fee basis about 70 granting European companies, the Notified Bodies (NB) , from Turkey to Ireland, require the applicant  to submit an application for the CE. Once the CE is obtained the product can be sold in all EU countries. Whereas for the approval of drugs clinical trials are mandatory as is the inclusion of the research literature covering any existing negative findings,  such obligation does not exist for medical implants in Europe.

The documentary addresses an urgent issue. Problems of a sagging pelvic area are encountered by women having given birth but also by others due to aging.  An estimated 25-33% of women develop these problems.  Insertion of vaginal mesh implants has severe consequences for about 30% of the recipients, frequently experienced several years after insertion. They include persistent pain, immobilization, infections, urinary dysfunctions, termination of sex life, loss of jobs and self-esteem, addiction to pain killers, to name but a few. Traditional surgical methods required hospital stay and surgery. That treatment included surgery, in which a specialist used a patient’s own tissues to provide support for the prolapsed organ. Anterior and posterior repairs are used to tighten the support tissues that hold these organs in place, restoring their normal position and function.  Since mesh implants were introduced the number of surgeons who can use the old methods dramatically declined. Apparently there are only one or two surgeons left in the Netherlands with that ability. Removal of the vaginal mesh once implanted is virtually impossible requiring sometimes multiple surgeries. Severe damage to the tissues with which it merged results because it fuses with surrounding area  attaching itself to blood vessels, nerves, and organs. Since the documentary was shown in the fall of 2015 there was a 90% decline in the use of vaginal mesh implants after its transmission on a Dutch PBS station in the Radar series of consumer protection programs. The documentary was based on an investigation lasting close to a year. The medical profession in the Netherlands reacted negatively. Gynecologists are opposed to a ban on meshed implants. High revenue is generated from an implant placed through a minimally invasive step.

Scientific articles reported as already as 2010 that the traditional methods were superior to vaginal mesh implants a finding questioned by the giant Johnson & Johnson which marketed the implants at great profit. Mesh implants were invented by the manufacturer MS and picked up by Johnson & Johnson and other companies. Produced at a cost of about $1 it was sold for $1,000 each by J&J. Last year the corporation was fined in the first US mesh implant court case $11 million, a judgement J&J is appealing.

The application for the CE sales certificate requires a technical report with, detailed description of the product, a review of the pertinent literature and the plan for the manufacturing facility. Literature from the CE application for identical competing products can be used. Applicants are not obliged to include in the literature section material covering negative data about medical implant consequences. The Radar producers decided to file under cover an application for a CE for their “I Solve-TEM” mesh device and recorded with hidden cameras the fee based seminars provided by a CE granting company or Notified Body, personal interactions with three of these NBs as well as phone discussions about Radar’s product application. The information derived was complemented by interviews with legal and scientific experts.   Though not required Radar investigators included in the technical report of their application references to publications showing a 30 % failure rate of the device and enlarged their mesh configuration to make it more risky.  The mesh consisted of the same mesh used for mandarins, as reproduced in their application.  Mandarin mesh made of synthetic polypropylene includes chemicals that scientific reports identify as most harmful to the human body. Mesh expansion in the body is not assessed, in its box it is about 20%.

Scientific articles reported as already as 2010 that the traditional methods were superior to vaginal mesh implants a funding questioned by the giant Johnson & Johnson corporation marketing the implants at great profit. Mesh implants were invented by the manufacturer AMS and picked up by Johnson & Johnson. Produced at a cost of about $1 it was sold for $1,000 each. Last year the corporation was fined in the first mesh implant court case $11 million, a judgement J&J is appealing. Once the undercover Radar brochure with the technical report and other required elements project was distributed to the 69 Notified Bodies, numerous companies approached responded to review their application for a fee of several thousand euros, a charge they were able to negotiate down in most cases. Radar listed an address in Israel for the location of their production facility. Reviewing their application several of the CD granting companies contacted assured the investigators that there was a 99% probability of receiving the CE. Once he CE was secured the Radar group could commence production and sales of their I Solve-TEM with an inspection of their facility due after one year of operation.

When Radar investigator reported their findings to health officials of the European Union they seemed to be unaware of the catastrophic consequences of vaginal mesh implants and of other medical implants and responded that it will take three or more years before action effective action can be taken by the EU, provided that all 28 members of the EU agree, thus no solution is in sight until 2018. After release of documentary only several of the CE granting companies closed down.

Claus Mueller,  filmexchange@gmail.com