Specialist Product Liability Lawyers Raise Concerns Over Trans-Vaginal Mesh Products

FDA Now Consider Product More Risky For Patients

07.01.2016

Oliver Wicks, Press Officer | 0114 274 4649

Specialist product liability lawyers at Irwin Mitchell have raised concerns over the safety of trans-vaginal mesh (TVM) products after US Food and Drug Administration Agency (FDA) announced that it now considers TVM products to be a higher risk for patients. 

The increased category of risk from class II to class III was implemented after thousands of women issued legal claims against various manufacturers of the TVM products, alleging they suffered serious and debilitating side effects of the mesh such as pain, bleeding and difficulty having intercourse. However the change does not mean that TVM products have been taken off the market. 

Class III medical devices carry a higher risk of adverse events, which will mean that manufacturers will be required to submit pre-market approval to the FDA before releasing their products to the market. The pre-market approval will mean manufacturers will have to show their TVM product is safe and effective in treating a condition known as pelvic organ prolapse. 

TVM products have been under scrutiny for a number of years both in the USA and UK following concerns raised by women affected by these devices. 

In 2011 the FDA’s Obstetrics and Gynaecology Devices Panel first recommended that TVM products be re-categorised as a high risk category. 

If you or a loved one has suffered due to transvaginal mesh (TVM), our expert personal injury solicitors could help you claim compensation. View our Transvaginal Mesh (TVM) Claims page for more information.

Sallie Booth, a Partner and product liability expert at Irwin Mitchell, who is currently advising on several cases relating to issues with TVM products, said:


Expert Opinion
“Trans-Vaginal Meshes are very high risk products and should in effect only be used as a last resort treatment option.

“The reclassification of TVM products should bring more awareness to patients of the fact that these are such high risk products. It should also help to ensure that women are properly informed of the risks associated with these products and for their treating consultants to advise of all alternative procedures available to them.

“A reclassification of this medical device will hopefully also lead to more accurate data about the safety of these products in the long term which has been woefully inadequate to date. It will also bring about a more effective and controlled way of introducing these products to the medical market with more scrutiny before they are available to use.

“Steps such as this taken by the FDA are important in identifying and improving safety standards, in the hope that devices like this no longer expose patients to the risk of serious injury.”
Sallie Booth, Partner