Private Healthcare Australia has called for increased transparency across the medical device supply chain in response to Senate Inquiry report into the “number of women in Australia who have had transvaginal mesh implants and related matters”.

PHA Chief Executive, Dr Rachel David, said the report highlighted the need for a more rigorous evidence base to ensure that medical devices are safe for patients, including effective post‐marketing surveillance on all implants and formal registry data for new implants.

“Better post-marketing surveillance will help to avoid these adverse events in future, ensure they can be quickly identified and addressed in the interests of patient safety,” Dr David said.

The report identifies hundreds of women who have been adversely affected by transvaginal mesh devices that were on the Australian Register of Therapeutic Goods and the Prostheses List over a period of many years.

“Private Healthcare Australia supports the reforms the Federal Government has already made to the Prostheses List, including bringing down the cost of medical devices from grossly inflated levels, but more needs to be done to shine a light on practices across the medical device supply chain,” she said.

“Health funds want stricter controls on the support and other benefits provided by manufacturers and suppliers to providers, and controls on the use of sales representatives, particularly their presence in operating theatres without patient consent, and their use in training surgeons and staff.

“The attendance of sales reps during surgical procedures escalated dramatically since the Prostheses List appeared in its current form in 2006. The seriousness of this issue has been highlighted by this inquiry. The unregulated use of reps in routine cases is at best a costly waste of money and at worse, unsafe. When additional services are clinically relevant they should be costed separately in the interests of transparency.

“Health funds are of course willing to pay for additional services when they are clinically relevant to the patient, however funds are concerned that their members are being charged more so some medical device company sales reps can attend surgical procedures to promote the device. Under no circumstances should health fund benefits be used to support sales activities of manufacturers where there is no patient benefit.

“Introducing a reporting system, not unlike that operating in relation to pharmaceuticals where Medicines Australia discloses support, incentives and other benefits provided to prescribing doctors, is essential to both price the support given by manufacturers to providers annually and better understand the nature of the support and benefits provided.

“It makes no sense that Australia has a rigorous system for disclosure of benefits paid to providers by multinational pharmaceutical companies, but not medical device companies. A patient can stop taking a medicine that is harming them, but once a medical device is implanted in the body it can be difficult or impossible to remove.

“Mesh products have irreversibly harmed hundreds of women, so it is clear industry self-regulation is not working. This is not the first large-scale scandal involving implantable devices and it will not be the last unless the government acts now to require full disclosure of inducements and benefits supplied to doctors and hospitals.

“Such controls will bring the transparency of the medical device supply chain into line with what is expected of similar industries. It is also critical that devices found to be unsafe are removed from the Prostheses List at the same time they are removed from the ARTG, so that patients are not harmed,” said Dr David.

 

Media contact: Jen Eddy 0439 240 755