***For the attention of Lord O’Shaughnessy, Lord Hunt, Baroness McIntosh, Baroness Jolly, Lord Patel and Baroness Tonge ***
Dear Lords and Ladies,
I am grateful to you all for your contributions to the review of the safety of pelvic mesh implants in the House of Lords last week, on Tuesday 6th February 2018.
There has been some progress made in relation to awareness of this health scandal, which until last year, had largely gone unnoticed and unreported here in the UK. Injured patients have been campaigning to raise awareness of mesh complications for over a decade. To some, the awareness of this scandal is only starting to unfold, but there are still many aspects of this scandal that simply aren’t being acknowledged by the media coverage and discussions happening in parliament are not accessible to all mesh injured women in the UK.
As someone injured by mesh for stress urinary incontinence in 2009, this devastating health crisis has shaped my whole world ever since I woke up in the recovery room in tremendous pain. Like Thalidomide, mesh devices came to market without rigorous safety testing or human trials. A dangerous loophole in the regulation of medical devices, known as the 510(k) process, allows the FDA to clear new moderate or high-risk devices for market based on the similarity to an older device already on the market, even if that older device has been removed from the market because it injures or kills patients. This is exactly the case with regards to vaginal mesh. Our regulatory boards, including the MHRA and NICE, generally follow the current stance on pelvic mesh use by the FDA. With legislation that seeks to promote the corporate interests of industry over patient safety, we as campaigners and patient advocates are fighting an uphill battle.
Pharmaceutical companies have developed excellent marketing strategies to lure the medical community to accept minimal proof of benefit over risk. Various court cases dealing with pelvic mesh device litigation in the US have brought to light some serious concerns about the marketing of these products by medical device manufacturers including suppression of information within the companies which resulted in a failure to provide adequate warnings, and failure to provide post market studies (J&J destroyed all their documents pertaining to vaginal mesh despite being asked by the courts to retain this information). I welcome the fact that Lord O’Shaughnessy has asked NICE and the MHRA to investigate why Australia and New Zealand have implemented bans on pelvic mesh usage and echo Lord Hunt’s suggestion that a suspension of mesh use at the current time in the UK would be appropriate. I will hold out hope that this evidence will be collected and assessed as soon as possible. Until efficacy is proven mesh should not be used routinely for either pelvic organ prolapse or stress urinary incontinence. The benefits cannot outweigh the risks when no one is being honest about those risks in the first place.
This is a complex issue at the best of times but is now even more difficult to navigate given the move towards the UK leaving the European Union. Ultimately the impact of trade deals and regulatory controls cannot be seen as a separate issue. They will have a direct impact on the clearance of medical devices in the UK after March 2019, and this is something that must inform any decisions made in relation to this enquiry into the safety of pelvic mesh devices in the coming months. Reviews are essential, but so is looking and planning forward, and learning from mistakes made under the current systems.
Following the Life Sciences Industrial Strategy white paper, published in November 2017, it is my understanding that when we leave the EU in March 2019, we will continue to follow EU regulations, allowing a two-year transition period to roll out any changes made to our regulatory framework. UK medical devices companies will need to continue to meet the relevant EU standards for their products, and if they fail to do so because they are no longer bound by the laws of the EU, it may lead to reduced trade with the EU and the rest of the world.
In the event that a different, and new, set of laws are established to govern the UK medical devices sector, it may have profound implications on the sector as a whole. The new laws may be drafted in such a way which gives medical devices companies a more relaxed framework in which to operate within. This certainly appears to be a central concern in the current parliamentary discussions on the regulation of medicines and medical devices. Emphasis on trade, customs, and the economic impact of regulatory controls on the sector, knocks patient safety much further down the list of priorities. With an economic recovery plan that prioritises commercial interests and puts patients in harm’s way, this crisis with continue to escalate. The emphasis on creating a regulatory environment that will allow innovative new treatments to come to the market more quickly, is already underway. I refer to the Accelerated Access Report. This is due to be implemented in April 2018.
Vincent Cable asked a very pertinent question of the Prime Minister in the House of Commons on 7/02/18 regarding negotiations with the Trump administration on a post-Brexit trade deal between the UK and US;
“The Prime Minister knows that one of the key objectives of American trade negotiators in any future deal after Brexit is to secure access for American companies to do business in the NHS. Will she give an absolute guarantee that the NHS will be excluded from the scope of those negotiations? Will she also confirm that she has made it absolutely clear to President Trump in her conversations with him that the NHS is not for sale?”
To which she responded;
“We are starting the discussions with the American Administration, first of all looking at what we can already do to increase trade between the US and the United Kingdom—even before the possibility of any free trade agreement. The right hon. Gentleman does not know what the American Administration are going to say about their requirements for that free trade agreement. We will go into those negotiations to get the best possible deal for the United Kingdom.”
If these negotiations continue to focus on a close relationship between industry and government as the Industrial strategy is implemented over the course of the next few years, the best possible deal must not sacrifice patient safety and access to safe medical care for the sake of economic recovery. We need only look at the impact the 21st Century Cures act, implemented by the Trump administration in the US last year, to see the influence big pharmaceutical companies have on shaping government policy. The 21st Century Cures Act – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices. The loosening of these regulations bows to the powerful interests of industry and weakens even further the already inadequate oversight of medical devices and drugs. Any move by the UK government to adopt an American style system, will take us from Little Britain, to Little America. If a deal with the US is secured, and our NHS is privatised as part of any deal made between the UK and US administrations, what recourse will mesh victims have then?
The problems with mesh devices go way beyond the consent process and dissemination of guidelines to clinicians and patients. If this scandal is only addressed as an issue of safety, with regards to consent, you are only going to be addressing a small fraction of the systemic problems at the root of this scandal. The medicalisation of our bodies for profit is at crisis point, and the sooner the UK government face this fact, the better.
I include in support of this letter, two previous letters I sent to Owen Smith MP., on this issue. These letters go into more detail on the systemic corruption at the heart of this scandal, and a call for a standard of care for mesh injured women who are fighting daily to be heard, to be seen and to be cared for by the medical community.
Professor Linda Cardozo, OBE., (spokeswoman for the Royal College of Obstetrics and Gynaecology) recently spoke in parliament on the mesh scandal and has come under fire for saying, “You can’t make an omelette without breaking a few eggs.” Mesh victims are deeply upset and angry with her flippant disregard of our pain and suffering. If you are making an omelette, the rule is, you must break the eggs first. When it comes to mesh, and the eggs being broken are human beings, you have a duty of care to stop breaking those eggs, and to do everything in your power to fix us again. We deserve that at the very least.