SAFETY & LEGAL ISSUES SURROUNDING VAGINAL MESH IMPLANTS
Problems caused by vaginal mesh implants, which have left thousands of women worldwide in severe pain and some permanently disabled, have been recently highlighted in the media and have been the subject of numerous calls to our medical negligence team at our office in Cork, by affected parties.
The plastic mesh is used to treat organ prolapse and incontinence, usually after childbirth. The implants are surgically inserted to support the vaginal wall or nearby organs such as the bladder or bowel. These surgical mesh devices, are also sometimes referred to as pelvic mesh, pelvic slings or transvaginal mesh. These devices have been marketed by the manufacturers as a means to repair a host of pelvic disorders in women, but nonetheless, in some cases, they have proven extremely dangerous.
In the majority of cases, the procedure works well – but thousands of women worldwide who have suffered painful and distressing complications are suing the relevant health services and manufacturers of the mesh. Adversely affected patients in Ireland have been recently seeking legal advice also.
Difficulties include sharp pain on mobilising, findings on vaginal examination of migration or incision of other organs by the implant, and sexual difficulties/injuries for both partners.
The thin plastic netting is made from a material polypropylene, also used to make plastic chairs and drinks bottles.
Its surgical insertion is intended to be permanent, but the mesh can cut through the wall of the vagina, with some women left unable to walk, work or have sex – with the protrusion so severe in some cases it has also injured partners during sex.
There has been thousands of complaints and adverse event reports in respect of the device. It doesn’t appear that any, of the tens of variations on the market, have been recalled to date. In the US, transvaginal mesh is classed as a high-risk device, but is still used. The US Food and Drug Administration (FDA) said last year it has seen “a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal pelvic organ prolapse repair”.
The safety of medical devices such as vaginal mesh implants is governed in the main by The Liability for Defective Products Act 1991. This legislation aims to safeguard consumers from products that do not reach a reasonable level of safety and cause foreseeable injury or damage through for example a manufacturing error, design defect or inadequate information on the appropriate use of a product. The main effect of this legislation is to introduce into Irish law the principle of “strict” liability on the producer, and in certain circumstances, the supplier of a defective product. Strict liability is the imposition of liability without fault, for damages, on the manufacturer or supplier. This is different from medical negligence cases (not involving defective products).
There may also be a medical negligence aspect to litigation involving surgically inserted medical devices, such as vaginal mesh implants, if it can be established that the medical practitioner breached the duty of care i.e. the care afforded to the patient was not of the requisite standard and that “but for” the medical negligence/breach of duty of the treating medical practitioner the outcome would have been far different. Breach of duty may relate to the surgical insertion of the device, the follow up care or indeed the selection of a particular medical device itself over other similar products.
Apart from giving rise to liability on the part of the manufacturer and/or supplier of the product, there may also be a liability for a Medical Practitioner / Hospital or the HSE if they supply defective medical products which are not of “merchantable quality” or “fit for their purpose” under the Sale of Goods and Supply of Services Act 1980.
Defective Product litigation throws up a number of practical legal issues:
(1) Identifying the correct Defendant(s) for the purposes of legal proceedings. There are often a number of parties involved in the process:
- The original manufacturer,
- The European supplier and/or distributor,
- The medical facility that purchases and recommends the product to their patients, and
- The physician who inserts the product.
(2) The manufacturers of medical products are often based outside the jurisdiction and even outside of the E.U. If such is the case the permission of the Court must be obtained to issue legal proceedings against Defendants that are based outside of the E.U.
(3) Injuries Board – A defective product action involving personal injury must in the first instance be assessed by the Injuries Board. However, if there is also a medical negligence aspect to the case the Injuries Board may not assess the claim and instead an Authorisation should be sought from the Injuries Board to proceed with the case through the appropriate Court.
(4) Statute of Limitations – The law in relation to time limits when a personal injury is involved is generally two years from the date of wrongdoing i.e. insertion of the defective device. The Legal Services Regulation Act 2015 will extend the period for the bringing of clinical negligence actions to three years. In some situations the time can be extended for those who did not have knowledge of the wrongdoing (or alternatively that the person did not have knowledge that the wrongdoing caused the injury).
In addition, Section 7(2) of the Liability for Defective Products Act 1991, contains what is known as a “long stop gap”, namely that a right of action for a defective product case shall be extinguished upon the expiration of ten years from the date on which the product was put into circulation. This Section is not conditional on the person being “reasonably aware” of the damage, the defect or the identity of the producer (ie the manufacturer of the product).
One should always move expeditiously with defective product/medical negligence case and should contact a Solicitor as soon as possible for advice on the specific time limits applicable to their case.
If you are a patient who has been affected by any of the issues raised in this article, we suggest you contact a member of the Medical Negligence Team at Cantillons Solicitors, 38/39 South Mall, Cork on 021 4275673 or firstname.lastname@example.org as soon as possible.
* In contentious business, a solicitor may not calculate fees or other charges as a percentage or proportion of any award or settlement.