U.S. bans mesh as pressure mounts on British regulators

Jeffrey Shuren, MD, JD
Jeffrey Shuren, MD, JD

US medical regulators have banned mesh implants for pelvic organ prolapse after manufacturers failed to prove they were safe.

The ban puts more pressure on UK watchdog NICE after it decided the controversial implants could safely be reintroduced in England.

Dr Jeffrey Shuren, director of the US Food and Drug Administration’s Centre for Devices and Radiological Health, said: “Patient safety is our highest priority, and women must have access to safe medical devices.”

Compensation paid to mesh victims in the States has already topped £10 billion.

Campaigner Elaine Holmes of Scottish Mesh Survivors said the FDA move was “too long overdue” and criticised NICE for “even suggesting this product should be brought back”.

Ms Holmes said: “Hundreds of thousands of women around the world have suffered life-changing injuries. How many more must die and how many more families will be left to pick up the shattered pieces before our medical regulators do the right thing?”

NICE made the announcement that it supports the continued use of pelvic organ prolapse mesh by specialist surgeons once a register is set up linking adverse incidents to the Medicines and Healthcare Products Regulatory Agency (MHRA).

It previously supported the withdrawal of pelvic organ mesh, and a change of heart sparked outrage among campaigners.

Mesh implant use is currently suspended across the whole of the UK pending an inquiry by Baroness Cumberlege who has been outspoken about the injuries suffered by thousands of women.

Politicians in Scotland say they will continue to back the campaign against the reintroduction of mesh.

MSP Neil Findlay said: “This a major move by the FDA.

“This should send a message to health regulators across the world that mesh should not be used in women’s bodies.”

An MHRA spokeswoman said: “We are aware of the FDA’s decision and we will closely monitor the situation and consider what action, if any, is needed.”

A NICE spokesman said: “At the time of publication NICE’s updated guideline, the high vigilance restriction is still in place and, until it is ends, professionals should continue to follow its requirements.”