Hugh James has been instructed by women who have had surgical mesh implanted to help repair pelvic organ prolapse (POP). The claim is that rather than help the tissue to repair itself as it was intended, the surgical mesh has resulted in further injury to many of the women who have had the devices implanted.
In 2016 the Food and Drugs Administration (FDA) in the United States changed the classification of surgical mesh to repair POP transvaginally from a moderate-risk device to a high-risk device. Research has shown that surgical mesh for transvaginal repair of POP can cause complications such as mesh erosion, pain, infection, bleeding, pain during sex, organ perforation and urinary problems. Many of these complications require additional treatment including surgery.
The NHS England oversight group published a final report of its review of the use of mesh implants in July 2017. The report stated that the use of mesh to treat women with stress urinary incontinence and pelvic organ prolapse is a safe option, but there is a “need for better information for women experiencing SUI and POP, better data and a multi-disciplinary approach to caring for woman”. The report provided information on action that was necessary in providing better information to patients on the procedures and potential complications; as well as updating clinical guidelines for surgeons and GP’s. It is also intended that there will be better record collection from clinical practice to ensure that complications are properly assessed.
Litigation is being pursued at length in the United States and there have been numbers of cases in which manufacturers have been ordered by the courts to pay damages to those affected.
Draft guidelines from the health watchdog NICE say that implants should only be used for research and not routine operations and is recommending the banning of them for treating organ prolapse in England. NICE said that there were “…serious but well recognised safety concerns” and that “…evidence of long term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity”. It has said that “when complications occur, these can be serious life changing consequences” but acknowledged “…most commentaries received from patients reported satisfaction with the procedure”.
NICE suggests “…randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair”.
Hugh James will investigate claims for women who have received mesh as part of POP repair. It will also investigate claims that informed consent has not been given in individual cases because the level of information given to the patient before agreeing to the implantation was inadequate.
Court proceedings have to be started within three years of the patient knowing that they have a problem from the product and in claims under the Consumer Protection Act 1987 alleging that the product is defective, there is an additional “long stop” extinguishing time limit. That is to say that the right to sue is lost once ten years has expired from the date that the product was put into supply. In medicines and medical devices there may sometimes be quite a delay between the time that the product leaves the factory and the time that it is actually implanted.
If you have had surgical mesh implanted for pelvic organ prolapse, one of our solicitors can check to see if your implant is one that has been listed as defective.