Despite growing and convincing evidence that complications from synthetic mesh implants are not rare and are ruining the lives of many women, the Medicines and Healthcare products Regulatory Agency (MHRA) remain reluctant to fully acknowledge the problem and to act with any real vigour to address the mesh problem adequately. This is a scandal in the making.
Background to the Mesh Problem and Campaign
For several years women who have suffered complications as a result of mesh implant surgery have been raising concerns individually and in support groups with the UK’s regulatory body, the MHRA regarding the use of synthetic meshes in gynaecological surgery for prolapse or stress incontinence. The concerted campaign has also targeted various members of Parliament, medical bodies such as the Royal College of Obstetricians and Gynaecologists (RCOG), and the media with varying levels of response.
Women have argued that synthetic mesh is being used indiscriminately by surgeons, that complications are often distressing and sometimes debilitating, that the product has not been adequately tested before being used on women, and that mesh surgery is not necessary as alternatives are available which do not expose the patient to the unique risks posed by mesh. They have pointed to growing evidence that complications are not rare and, as sufferers themselves, they have given testament as to the nature of these complications and the negative effect on quality of life, and the fact that, for some, complications can appear many years after the original surgery.
These patient groups have called for mesh surgery to be much more strictly regulated and restricted, believing it to be exposing women to unnecessary risks. They have asked for an urgent review of mesh products, and an investigation into their approval and regulation. They have highlighted evidence that polypropylene mesh is not inert, as purported by some medical professionals, and can shrink, move and degrade inside the body and cause chronic foreign body reaction.
Growing Evidence of Problems with Mesh
Between 2008-2010 the FDA’s MAUDE database in the US recorded increasing numbers of reports of women suffering complications from mesh. The FDA made announcements regarding mesh surgery in 2008 and 2011. They indicated that complications were not rare and warned that caution should be exercised, especially with respect to mesh used in prolapse surgery. They ordered post-market surveillance studies to be carried out by several mesh manufacturers.
One of these mesh manufacturers, pharmaceutical giant Johnson & Johnson, subsequently announced it was withdrawing four of its Gynecare mesh products from the market.
In the last year there have been successful landmark trials involving prosecutions for mesh implant surgery in the United States and these have been further testament to the problems with mesh safety. Evidence presented in the latest trial showed significant rates of complications. Over 2,000 more cases are awaiting trial against Johnson & Johnson. In total, there are over 10,000 cases awaiting trial in consolidated litigation in the US involving a number of manufacturers and mesh products.
In Australia, there have been further reports of mass litigation against mesh manufacturers.
Support groups are emerging all over the world: certainly, there are numerous sites in the United States and several in the UK. There is a support group being set up in Canada and there is one in New Zealand for sufferers ‘down under’. There is also a support group originating in Belgium.
What have the MHRA done about mesh?
In 2011 the MHRA eventually responded to campaigning by mesh victims by putting a notice on its web page with some links, following a “workshop” it held with members of the Royal College of Obstetricians and Gynaecologists (RCOG), the British Association of Urological Surgeons, and the British Society of Urogynaecology. Unfortunately, patient representatives were not present but proponents of mesh, including manufacturers, were.
A report was published which focused on synthetic tapes for stress incontinence and “improved regulation of new devices” – this was only accessible by payment of a paywall fee until campaigners lobbied for it became free to access. The report recognised the increasing number of reports of mesh complications but appeared to make recommendations focusing on self-regulation, such as the training of surgeons and the reporting of adverse events. Although there was a call for better tracking of patients and reporting of patient outcomes or adverse events, it highlighted that there is currently “no obligation to follow patients or to use registries”. There was every indication that mesh was here to stay.
The MHRA continued to argue that mesh complications were rare and responded to campaigners emails with a cut and paste reply, patronisingly reminding women that “all surgery has risks”, as though they were not already aware of this fact. They referred to their Adverse Event Reporting system, which had received very few reports of complications.
There were also numbers of stories in the press about the poor regulation of devices in the UK and the lack of transparency where device regulation was concerned. I contacted the MHRA to request information about the TVT implant, asking which notifying body had approved the TVT device and on what evidence. I received a reply which was undoubtedly intended to bamboozle and confuse and to essentially hide the fact that they could not really provide me with the answers.
In the meantime, Lord Howe’s report on the PiP implant scandal was published, following investigations into the faulty breast implants. Although the MHRA escaped full-on blame for the scandal, in which women were implanted with implants filled with industrial-grade silicone exposing them to increased risks, it was noted that lessons must be learned and recommendations for future improvements were made. These included recommendations to use rich sources of information. “The MHRA needs to look at how it gathers evidence so it is able to identify problems early.”
In a BMJ article Carl Heneghan pointed out the need for implants to have rigorous assessment of evidence and adequate device reporting. Although much focus is given to registries as a source of post-marketing surveillance, there is a lack of strategy in this area. Dr Heneghan noted that the PiP implant scandal was a straightforward story popular with the press because there were clearly bad practices on the part of the manufacturer; however, the problems with some metal-on-metal hip and other implants are “much more complicated”.
In February 2012, following requests by Teresa Hughes of support group Meshes United who approached her MP Shaun Woodward, figures were published which showed the numbers of mesh insertion and removal surgeries for TVT in England. These suggested that complications were much higher than purported, and showed a mesh revision/removal surgery rate of 4-6%. These figures were apparently obtained from the Hospital Episode Statistics and so were available at any time to the MHRA or any interested parties, such as the RCOG.
Further campaigning kept up the pressure on the MHRA and they once again reluctantly convened another closed meeting with surgeons and manufacturers.
Susanne Ludgate, medical device director at the MHRA, pronounced that she was listening to the concerns of mesh sufferers, and agreed to meetings with the head of both UK support groups to demonstrate her commitment. Sadly, these efforts were later shown to be somewhat of a sham listening exercise.
The ‘York Report’
As a concession to campaigners, the MHRA announced they were commissioning a report into issues surrounding mesh. This news was met with joy amongst many mesh victims that the regulating body was finally going to do its job and seek the truth through a wide-ranging investigation. Unfortunately, it was these patients who were to later find out the truth when the disappointing report came out: that this report was simply an exercise in deflecting potential blame and criticism away from the MHRA in the shadow of the recent Pip and De Puy hip scandals.
The MHRA’s commissioning of this report by the York Health Economics Consortium, a company owned by York University, proved to be a curious decision. Why would a regulatory body responsible for the safety of medical devices, pay for the services of this group who appear to have no medical qualifications or gynaecological expertise? Could it be that there was a perceived need by the MHRA to be seen to be doing something when there was actually no interest in getting to the truth behind another potential scandal?
The York Health Economics Consortium research team was led by a member of staff who appears to be a qualified librarian. The report her team produced lacked academic rigour and was basically a rehashed summary of old, previously published literature reviews. The report lacked any firm conclusions and failed to bring anything new to the debate. There was no attempt to use rich sources of information, such as:
- Investigation of the nature and numbers of cases awaiting trial in the United States, some now the subject of successful litigation procedures.
- The MAUDE database statistics from the US showing adverse events and referred to by the FDA.
- The FDA’s report on meshes used in gynaecological surgery.
- The statistics raised by a UK Members of Parliament highly suggestive that adverse events are under-reported.
- Further sources of statistics which could have included the Hospital Episode statistics from Wales, Scotland and Northern Ireland if available.
- Qualitative data which could have included discussions with support group members and mesh patients, similar to the type of activity carried out by Tom Joyce, Biomedical Engineer at Newcastle University who investigates joint replacements.
- Data from tertiary centres and interviews with mesh surgeons who perform mesh removals.
- Data and interviews from pain clinics involved in treating mesh patients
- Investigation and evaluation of research into mesh products and properties, such as the reports that mesh is not inert but may be liable to contraction and degradation inside the human body.
- Assessing how many mesh products are in use in the UK and on what grounds they have been approved and whether further research might be required
- Examining successful registries such as the hip registry and how this could be applied to mesh implants. Thanks to the hip registry, the harmful de Puy hip was removed from the market (although again the MHRA was accused of being slow to react)
In November 2012, having published this report with some fanfare, the MHRA updated their website with pages of supposedly helpful advice, extracts from the report, and links on mesh surgery, but produced nothing of any consequence to address the mesh problem. Dismissive of the problems suffered by many women, the MHRA quoted Professor Keith Willett in their press release (Nov 2012): “For the vast majority of women, mesh and tape implants are a safe and effective operation, but as with all surgery, there is an element of risk.” On the basis of this report, Susanne Ludgate added: “Whilst a small number of women have experienced distressing effects, the current evidence shows that when these products are used correctly they can help with the very distressing symptoms of these conditions and as such the benefits still outweigh the risks”. Job done.
The RCOG, in its bias towards the status quo, jumped on the MHRA’s bandwagon, issuing an official statement by Vice President, Dr David Richmond: “The RCOG welcomes this report. It shows the adverse rates for vaginal tapes are quite low…It is important that clinicians adhere to the NICE guidelines and inform patients of the risks and benefits of any procedure”
Meanwhile, NICE, seemingly oblivious to campaigners’ concerns, published its draft new guidelines for surgery which now focus completely on the use of synthetic mesh for surgery for stress urinary incontinence.
A Scandal in the Making
It should be clear to anyone following these developments and litigation in the US that there is another implants scandal unfolding in the UK which the MHRA refuses to take proactive action to resolve. Once again, the MHRA appears to have been lulled back into its passive stance and will clearly only be dragged into meaningful activity when once more forced by events unfolding.
When will they start doing their job and protect women in the UK?
Women Receive Inadequate Information about Risks
Failing immediate and much needed improvements in device regulation to limit the use of mesh, at the very least mesh sufferers want women to be better warned and informed about the true risks. But that doesn’t mean women should have to do extensive internet research before their surgery, a luxury and skill not possessed by all. Information and links on the regulating body’s website are not the answer.
Surgeons have a duty to inform women of the full and long term risks of mesh surgery and their hospital literature should reflect the fact that mesh is not the only option, mesh poses risks not present in non-mesh surgery, mesh is intended to be permanent and is difficult to remove if there are problems further down the line. Women also need to know that there are thousands of cases of women seeking legal redress for their mesh problems in the US.
All women should be given this information in plenty of time before their surgery and not, for example, a few hours before the surgery when they are rushed through the consent form. It is the surgeon’s moral, if not legal, duty to give the woman all the facts.
Difficulties Getting Help When Mesh Goes Wrong
Mesh victims have also alerted organisations to the fact that women are finding it difficult to get their mesh problems recognised and treated by surgeons experienced in mesh complications. Mesh surgery leaves a surgical footprint which can make it more difficult to resolve any problems later on if things go wrong. The mesh becomes firmly embedded in the body over several weeks and, if poorly placed, infected or eroding into nearby tissues or organs, the mesh can ultimately damage the vagina, urethra, bladder and other organs. Removal requires great skill if the surgeon is not to cause further damage and continence issues.
Call for National Registry
Some campaigners have called for all mesh implants to be recorded in a national independent registry so that problems can be recorded and reported and thus provide a more accurate picture of the mesh problem than that provided by the MHRA’s current adverse event reporting system, or the voluntary reporting system haphazardly and leisurely taking place at present. Some have backed the idea of a version of the Yellow Card reporting system so that patients and their primary care doctors could report any complications more easily, as with some drugs. In this way, the information from this system would rely less on the implanting surgeon’s subjective measure of success and his/her willingness to report adverse events.
Mesh Sufferers Go Public
Some women have been brave enough to tell their story on support websites and in some cases, in national newspapers. They are willing to reveal personal details about a rather embarrassing problem in the hope that they may help other sufferers and deter women from having mesh surgery. By going public they are highlighting the problems which are frequently downplayed or even omitted in the hospital information pamphlets or conversations with surgeons.