It has recently been reported that the American manufacturer Endo Health Solutions Inc. has agreed to pay $54.5million in compensation in relation to a number of product liability claims brought against them. The claims relate to their range of vaginal mesh implants, manufactured by their American Medical Systems Inc unit. It is alleged that the meshes, post-implantation, have eroded causing incontinence and pain in a large number of women.
In the past year, claims against Endo Health Solutions have almost doubled from 2,900 to 5,100 and whilst the settlement agreed will bring some of these claims to a conclusion, the majority of the claims against the manufacturer are still on-going.
The safety of implants of this nature, used mainly to treat the collapse of pelvic organs as well of urinary incontinence is being called into question as several other large American manufacturers are facing similar claims. Manufacturers such as Bard and Johnson & Johnson are facing claims relating to their implants Avalta Plus and Gynecare Prolift.
The implants complained of in these cases are not widely used in the UK. The implants that are most commonly used in the UK are manufactured by Ethicon (which is a subsidiary of Johnson and Johnson) and at present there is one case proceeding against this manufacturer in the US.
Ian Cohen, Practice Group Leader, Clinical & Medical Negligence commented: “The actions being brought in the US will not set a precedent worldwide, but do send a warning shot against the manufacturers of these meshes that high failure rates will not be tolerated by the Court. It has been well established for many years that there are risks associated with these types of medical devices, particularly when used in the context of vaginal prolapse surgery. At the moment the MHRA which governs medical devices in the UK has not sought conclude that they are too dangerous and this is partly due to a recognition that in the majority of patients they do seem to be effective.
Nevertheless, patients must give due consideration to these risks when considering whether or not to proceed with surgery and discuss all aspects of their treatment with their doctor. It is also important that the surgeon using any mesh has the right level of experience.”
Click here for further information regarding the cases proceeding in the US.