IN 2003 the Australian regulator responsible for ensuring only safe and effective medicines and medical devices are approved for the Australian market registered a medical device to treat women’s prolapse – the pelvic weakness that can occur after pregnancy or childbirth.
The mesh tape device approved by the Australian Therapeutic Goods Administration (TGA) was related to mesh devices used to treat urinary incontinence.
More than 40 transvaginal – through the vagina – mesh tape devices for use in prolapse surgery were on the market by the time alarm bells were ringing less than a decade later in Australia and America.
It was women who experienced catastrophic injuries from transvaginal mesh device prolapse surgery who forced regulators to act. In America the Food and Drug Administration went from saying in 2008 that injuries from devices were “rare”, to a 2011 declaration that serious adverse events were “not rare” and could be “life-altering”.
In 2012 the TGA said it was “use of the meshes rather than meshes themselves” that led to serious problems. By late 2014 it de-registered the first devices and demanded clinical evidence that should be standard, but was so lamentably lacking with transvaginal prolapse mesh.
The unfolding disaster is well on the way to being one of the biggest medico-legal debacles in history. The device approved by the TGA in 2003, based on an earlier approval in America, is now the subject of a class action by nearly 30,000 women in America, joined by hundreds more in Australia.
There are already more than 70,000 court cases against manufacturers in America, where more than 60 devices were approved for the market. It is estimated the final number will top 100,000. By comparison, American courts have dealt with 192,000 asbestos liability cases.
The mesh device disaster is not just a women’s issue. It exposes how regulators failed in their core responsibility – to ensure safe and effective medical devices go on the market after a rigorous assessment process.
That did not happen in this case. As the TGA admitted in an extraordinary letter to a patient advocate in 2014, its assessment process in the case of transvaginal mesh devices was not “mature” and lacked “rigour”.
That is a shocking admission for the many Australian women living with the consequences when transvaginal prolapse surgery using mesh tape devices has gone wrong.