When a recommendation is received from a hospital consultant that an embarrassing little problem of stress urinary incontinence or a sense of urgency can be avoided through a simple, surgical procedure requiring no more than day surgery, the assumption is that the device to be fitted will have been appropriately tested and the surgeon skilled in implanting it. This has not always been the case for many women.

It has been a complete shock for a number of women, who have suffered enduring pain and infections following implantation of surgical tapes and mesh, to discover that the devices implanted avoided rigorous laboratory testing and clinical trials as had been their reasonable expectation. A medical device which has similarity to one already on the market may avoid the need for rigorous testing providing it can demonstrate that to all intents and purposes it is similar to or has ‘substantial equivalence’ to a device already marketed.

Substantial equivalence in the USA means that the new device is at least as safe and effective as the one already marketed. Once licensed in the USA the manufacturer can apply to market its products in the UK and elsewhere. In 1999 Boston Scientific voluntary recalled 20,000 of its mesh implants due to safety concerns after being in use for only 3 years. Bizarrely, many manufacturers used the Boston Scientific product as the ‘predicate’ or ‘device of substantial equivalence’ to secure licences for their own products. There are many mesh products being used today which obtained their licenses by having a similarity to a ‘withdrawn’ product without new clinical trial data or safety tests having been conducted.

There are 1,000s of legal claims being made by women in the USA for the harm they have suffered following mesh implantation and the figure is rising in the UK. Dr. Sarah-Jane Richards who is representing more than 60 UK patients who have received similar treatment has been shocked to discover that some of these products have had little safety scrutiny. Moreover, that some of the surgeons implanting these devices appear to have had little training before switching from using the more conservative treatments for stress urinary incontinence and prolapse.

‘There is no turning the clock back for my Clients’ Dr. Richards said. ‘Instead of being able to manage their original symptoms relatively easily with personal hygiene protection products readily available from supermarkets or a conservative surgical procedure, they agreed to undergo surgery which involved implanting a polymer based device without being properly advised of the risks they were taking or that their surgeon may have received little training in the use of these devices.

Many of my Clients have suffered severe and constant pelvic pain requiring life-long doses of strong prescription-only pain killers and numerous infections treated with high doses of antibiotics. Often their original symptoms have not improved following tape and mesh implantation but have become far worse a new symptoms suffered. Frequently surgical attempts to remove these implants have had to be abandoned for fear of perforating vital organs.’

If you have been treated with a surgical tape or mesh for urinary incontinence or prolapse and you wish to discuss the outcome of your surgery, please do not hesitate to contact Sarah-Jane Richards at Secure Law Ltd., on 02920 024043 or by email to sarah-jane.richards@securelaw.co.uk.