AU Investigation Questions Ethics Behind Mesh Study
Mesh Medical Device News Desk, July 5, 2017 ~ An Australian public health watchdog is launching an investigation into whether two doctors participated in a pelvic mesh study and implanted women without the knowledge of the women or the hospital.
The Victoria Health Minister, Jill Hennessy, is behind an investigation into a Melbourne public hospital. Victoria is a state in southeastern Australia.
Allegedly Dr. Richard Reid and Dr. Peter Petros assisted Dr. Max Haverfield in 2010 and 2013 without alerting the public or the hospital, and despite some conflicts of interest.
The paper was written by gynecologist Dr. Max Haverfield and published in 2015. See it here.
It concluded the device is “safe and effective” but Northern Hospital has no record of the trial or ethics committee approval, reports McCarthy.
The research study says “Ethics approval was obtained by the Ethics Committee, The Northern Hospital/Northern Health. Safety of the study was monitored throughout. Written informed consent was obtained from all patients.”
Dr. Petros is the inventor of the TFS and was director of TFS Manufacturing at the time of the alleged ethics violation.
At the time, he and Dr. Richard Reid were being monitored by the NSW (New South Wales) Medical Council after it had received complaints from women injured allegedly by pelvic mesh surgery.
TFS was taken off the market in November 2014 because of a lack of evidence on its safety and efficacy.
The 24-month study included women who experienced grade two to four prolapse.
Here are the archives- coverage from Newcastle Herald.
Reporter McCarthy is recognized as the persistent journalist who uncovered wrongdoings of the Catholic and Anglican churches concerning child sexual abuse.
Her reporting is credited with the creation of the Royal Commission into Institutional Responses to Child Sexual Abuse.
She has since moved onto transvaginal mesh and the harm it has caused.
Mesh News Desk has written about Dr. Petros application to re-invent the TFS as a treatment for sagging breasts. See the story here. #