We start by thanking Alex Neil, the Cabinet Secretary for Health and Wellbeing, for recognising the seriousness of the situation and the failures in the system. We are grateful to him for instigating a working group of mesh victims and health professionals. The group is working to produce a new patient information and consent booklet. That will include all known risks associated with polypropylene transvaginal mesh implants. That is something that we did not have but which should be available in every hospital in Scotland before a single procedure more is undertaken.
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We would like to stress that none of what we are asking for will benefit any of us here today. We cannot change what happened to us, but it is not too late to make the changes that we believe will protect others from future injury, saving them and their families from pain, frustration, helplessness and possible disability.
While other countries are now taking action—the USA by reclassifying mesh for some procedures as high risk and Canada by issuing warnings to hospitals and doctors—we are failing to bring in the measures that are needed to protect the unsuspecting others sitting in hospital waiting rooms right now.
We have been told that regulation and safety are issues for the European Commission. However, given that our First Minister shows political willingness to intercede over fishing quotas, we ask that he show political willingness to intercede over something that has such a detrimental effect on human life.
The Medicines and Healthcare products Regulatory Agency has confirmed that we already have the powers that are needed to make a difference in Scotland, and too many Scottish women are being hurt on a daily basis for us to wait on the slow-moving wheels of Westminster. The rest of the United Kingdom can follow suit, but let us lead the way.
Almost two months ago, a US court found the mesh implant of choice in Scotland—Ethicon’s Gynecare TVT obturator system—to be defective. If it is defective in the USA, it would likely be found defective here if a UK court were to examine the same evidence. However, because there is no implant register here, Alex Neil, the Cabinet Secretary for Health and Wellbeing, has had to admit that there are no available records to allow health boards to write to each woman who was given the defective implant, either to warn her or to check on her health.
We were not told that as many as one in five mesh implants can go wrong. When you consider that 11,000 women in Scotland have had the procedure, one in five suddenly becomes an alarming statistic. Further, as complications often take years to develop, we fear that we may just be the tip of the iceberg.
Women are still being told that their pain is not mesh-related because they have tape, not mesh. They are still being reassured the mesh that is inside them is safe and that it is different from the problematic mesh that is reported in the media. However, both claims are untrue. Our implants are all made from the same plastic polypropylene mesh. All transvaginal mesh is high risk and must be reclassified.
Using polypropylene mesh for a transvaginal procedure is a contraindication. Ethicon’s own website states:
“As with all foreign substances, GYNECARE INTERCEED should not be placed in a contaminated surgical site.”
Surgeons consider the vagina to be a clean-contaminated surgical site, and polypropylene mesh is a foreign substance.
Until each and every woman who is injured through mesh implants has been properly diagnosed and treated, and all complications have been judiciously recorded, we do not believe that the MHRA or NHS Scotland can continue to state that the procedures are safe or that the benefits outweigh the risks.
The present system has failed because it is voluntary. Although official figures show that 328 women endured multiple surgeries—with some having as many as 12 operations to repair damage that was caused by mesh—only 12 doctor-reported incidents have been received from Scotland by the MHRA. Why did those doctors not report the complications in 328 women? Because they did not have to.
I personally know of three women who have died following mesh surgery, but just one had reference to the procedure on her death certificate. Why?
There is confusion over numbers, missing data and underreporting and we ask that you hear our voice and support us in suspending these procedures, pending an independent and thorough investigation. This is an emerging global scandal that affects hundreds of thousands of women.
We might not be able to answer all your questions and we do not know how much the changes will cost in monetary terms but, in human terms, please, just look at all the women behind us.
We will leave our dossier with you for further information.