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Pryers have been instructed by a number of women who have suffered serious injury as a result of being fitted with transvaginal mesh/tape to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

The mesh/tape is usually made of polypropylene, a form of plastic. The mesh is inserted into the abdomen through the vagina. It is then attached to various ligaments in the abdomen to support organs, typically the bladder, uterus and rectum. The tape is inserted through the vagina and passed under the urethra. Both products aim to provide internal support to patients who have suffered prolapse/weakening of muscles, often as a result of childbirth, hysterectomy or menopause.

While, in some cases, the use of mesh/tape have provided relief from the symptoms of a range of very distressing conditions, it is not clear that, overall, that they have produced better outcomes than established methods of surgery that do not involve mesh/tape.

Risks
The main problems occur where the mesh/tape erodes its way through the vaginal wall, or where a sharp edge of the mesh/tape penetrates an organ. These conditions can be very serious and require surgery to remove the product. Blood vessels and tissue grow around the mesh/tape and it often requires many operations to remove it.

The American Food and Drug Administration (FDA) has studied the use and safety of transvaginal mesh for the last few years and has issued several warnings, stating that the risks appear to be considerably greater than expected; that repair with mesh might not be more effective than non-mesh repair; but might expose patients to greater risks.

Legal options
Claims will be brought as clinical negligence claims against the surgeon or NHS Trust responsible for fitting the mesh/tape. It might be alleged that a mesh/tape repair was not an appropriate option for the patient; that it was fitted incompetently; or that the patient was not warned of the associated risks and alternative treatments. In some cases product liability claims will be brought against the manufacturer alleging that the safety of the product is lower than the patient was entitled to expect and that it was possible for the manufacturer to have discovered this if appropriate tests and trials had been performed.

Time limits
In either case, court proceedings must be started within three years of the date on which the patient learnt that she had suffered a significant injury and that it might be the result of mesh/tape being used in surgery.

Additionally, in a product liability claim, court proceedings must be started within ten years of the date on which the mesh/tape was supplied by the manufacturer. This is the date on which it left the control of the manufacturer, probably to a distributor or an NHS Trust. It is not the date of surgery but will be considerably earlier than that and therefore this date may be imminently approaching for some patients.

Please call if you have had an operation involving transvaginal mesh/tape and you have concerns.

Most of Pryers’ clients’ claims are funded by conditional fee agreements (“no win no fee”), under which no legal costs are payable if the claim is unsuccessful. Legal costs are only payable if the case is successful and, in that situation, the majority of the costs are paid by the defendant.

Please contact Katrina Taylor at Pryers by email at katrina.taylor@pryers.co.uk or by telephone on 01904 55 66 00.

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