07.01.2016

FDA Now Consider Product More Risky For Patients

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: