Regulator's 'no sale' plea to vaginal implant manufacturers

MHRA appeals to suppliers not to do business with trusts that do not record usage or report adverse effects

In a rare move to help improve patient outcomes, manufacturers of vaginal tapes and meshes are being urged to consider refusing to sell products to trusts and surgeons who do not properly record usage and report adverse effects.

The Medicines and Healthcare products Regulatory Agency (MHRA) has made a number of recommendations to surgeons and suppliers following an investigation into outcomes for women undergoing surgery for stress urinary incontinence and pelvic organ prolapse.

Working with The Department of Health and NHS urologists and gynaecologists, the medical technology regulator has drawn up guidance aimed at improving outcomes and creating a better database to highlight any patterns

The MHRA has been receiving a number of reports of complications associated with vaginal meshes, in a few cases of a severe nature, leading to further medical conditions

Around 13,000 vaginal tape implants are used every year in the UK to treat women suffering from stress urinary incontinence, and 1,500 mesh implants are used for women with pelvic organ prolapse. A small percentage of these women suffer significant side effects after their operations, including pain and sexual dysfunction.

For vaginal meshes adverse rates of 15% have been recorded in some studies, while the rate is between 1% and 3% for vaginal tapes. However, these figures are difficult to interpret because a significant number of patients suffered problems before surgery.

Professor Keith Willett, national clinical director for acute episodes of care at the NHS Commissioning Board, said of the move: “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.

“Some women have experienced some distressing side effects and we are working closely with surgeons and the MHRA to make sure that improvements are made and patients are well informed about the benefits and potential risks with these procedures.”

As part of its ongoing surveillance of device safety, the regulator recently commissioned a report from York University Health Economics Consortium to review the available literature on adverse event rates associated with these devices.

The report summarises the most frequently reported adverse events associated with different tapes and slings used for stress urinary incontinence and with different meshes for prolapse. It states: “The majority of women with prolapse referred for the procedure of mesh insertion respond well to this treatment. However, the MHRA has been receiving a number of reports of complications associated with vaginal meshes, in a few cases of a severe nature, leading to further medical conditions. The most frequently reported adverse events have included mesh exposure, pain, sexual problems, mesh erosion and occasionally injury to nearby organs such as the bladder or bowel.

“These reports have not been linked to a single manufacturer’s brand or model and the MHRA has no evidence that the devices themselves have inherent problems that would necessitate consideration of any steps up to and including consideration of product removal from the market. However, this situation will be kept under on-going review.”

While 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

The recommendations for suppliers include the need to test devices thoroughly, including carrying out a full clinical assessment before putting products onto the market; ensuring ‘instructions for use’ are comprehensive and appropriately updated; including a unique device identification code for attachment to patient case notes; and reporting all serious adverse events as they are made aware of them.

But, in a surprise move, the regulator also asks manufacturers to ‘consider not selling their product to trusts and surgeons who do not properly record proper usage and report adverse events’.

In addition, guidance is being drawn up that will see the development of a registry for implants to help surgeons compare the outcomes of various treatments, building on the voluntary registries already established by the professional associations.

Dr Susanne Ludgate, clinical director for medical devices at the MHRA, said: “We listened to and understand the concerns that many women have about vaginal tapes and meshes. That is why we commissioned research to review the available literature on the safety and adverse effects associated with these products.

“While 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.”

In addition, the MHRA, working with the professional associations, has developed information for women considering the procedure or who are experiencing a problem with an implant.

For more details, click here.

Companies