AN American medical device company used research it claimed was conducted at Hunter New England Health Service to promote high risk pig intestine pelvic mesh in America, at least four years before women complained of serious mesh complications.
Hunter New England Health Service is investigating how Cook Medical issued media releases in September, 2006 citing a “94 per cent success rate” from alleged research at the health service involving Cook’s Surgisis prolapse mesh for women, by gynaecologist Dr Richard Reid, who went on to be an associate professor at Newcastle University.
The health service had no knowledge or record of the research, an alleged 12-month trial involving 98 women, ethics approvals, patient consents or Cook Medical’s media releases until contacted by the Newcastle Herald.
A Hunter New England Health spokesperson said Dr Reid applied to the Hunter New England Human Research Ethics Committee in October, 2007 – more than a year after the Cook medical release - for a trial involving “a new prolapse treatment”, but the application “did not proceed… and was not approved”.
“Hunter New England Health was not aware that Dr Reid’s work has been cited in promotional material for the product. To participate in any Hunter New England Health-approved trial, informed patient consent must be provided which is based on documentation approved by the Hunter New England Human Research Ethics Committee,” the spokesperson said.
In the 2006 media releases Cook Medical said “Research conducted by Dr Richard Reid at the Hunter New England Health Service in Australia, shows that at 12 months following the repair surgery, patients experienced a statistically significant reduction in all pre-existent symptoms”.
Dr Reid applied to the Hunter New England Human Research Ethics Committee in October, 2007 for a trial involving a new prolapse treatment, but the application did not proceed… and was not approved.Hunter New England Health Service
It said Dr Reid “conducted three studies on a total of 98 women following surgery for three forms of pelvic organ prolapse”. Findings included that “in 94 per cent of cases, the prolapse operations were a success at one year follow-up”.
It quoted Dr Reid saying: “Based on anatomic and functional outcomes measures, 94.6 per cent of the patients studied experienced outright or qualified success. My research also found that using Surgisis shortened and simplified what is traditionally a difficult operation.”
Cook Medical did not respond to Herald questions. Dr Reid did not respond to Herald questions on Monday.
A research paper about Surgisis mesh by Dr Reid, and identifying “Hunter New England Health Service, NSW, Australia”, appeared in the medical journal Pelviperineology in March, 2007.
In his conflict of interest declaration Dr Reid noted that he was “supervising investigator for a global multicentre, randomized clinical trial” comparing Cook’s Surgisis mesh with “suture only” pelvic surgery.
“Beyond this research funding from Cook Incorporated, I have no commercial or employment ties to any company,” the declaration said.
Cook Medical’s website from 2007 carried three papers by Dr Reid linked to his use of Cook’s Surgisis pelvic mesh, without identifying institutions. A 2011 paper written by Dr Reid about Surgisis was one of a number of papers by doctors used by Cook in 2015 in an unsuccessful attempt to stop the American Food and Drug Administration from reclassifying Cook’s pig intestine mesh to high risk.
In an editorial in June, 2015 Pelviperineology was described as the “home journal” of women’s pelvic floor specialists who supported the non-mainstream “integral theory system” of women’s pelvic repair, developed by Dr Reid’s Australian colleague, Dr Peter Petros.
The editorial openly criticised other medical journals “which place great store on the peer review system”, and said it published research “rejected by other pelvic floor journals”.
Dr Petros and Dr Reid have both held senior editorial positions on the journal. Both men are the subject of recent Health Care Complaints Commission investigations after serious complaints linked to pelvic mesh surgery.
Hunter New England Health Service is writing to Pelviperineology to request its name be removed from any published works, and to advise the journal it had not approved any such research.
It has also advised the NSW Health office of health and medical research. In its statement the health service said it routinely advised the National Health and Medical Research Council of unapproved research as part of its annual reporting schedule.
Cook Medical’s 2006 statement about the alleged Hunter New England Health Service research was released nearly two years before the first Cook high risk pig intestine Surgisis mesh for prolapse surgery was cleared for use by Australia’s drug and medical device regulator, the Therapeutic Goods Administration, in June, 2008.
A Cook Surgisis mesh for incontinence was cleared for use in Australia in April, 2005, but withdrawn by the manufacturer and cancelled by 2009. Cook also produces a range of mesh hernia repair devices.
In an interview last week with the Herald Dr Reid said he “went to the (United) States a couple of times and helped them (Cook Medical) design the shapes” of transvaginal meshes (where meshes to treat women dealing with complications after childbirth are implanted via the vagina rather than the abdomen).
Asked if he had completed any research for Cook, Dr Reid replied: “No, I don’t think so.”
He said he made some presentations at international urogynaecological conferences citing 94 per cent success rates using Surgisis, and had “discussions” with Cook about his results, but said “I have no idea what they’re relying on” to refer to research by him at Hunter New England Health Service.
Dr Reid said he had not carried out any surgery, either public or private, in Newcastle.
I have no idea what they're relying on.Dr Richard Reid about Cook Medical's media release
More than 600 American women have initiated legal action against Cook Medical for “pelvic repair system products”. Nearly 500 cases remained outstanding in court lists obtained by the Herald in February.
A Central Coast woman who launched legal action against Dr Reid in 2014, alleging serious complications after she was implanted with Surgisis mesh, reached a settlement with Dr Reid’s insurer in December. At least five other women have launched legal action against Dr Reid after alleging serious complications relating to pelvic mesh.
Dr Petros’s mesh delivery device based on the “integral theory”, which was developed and registered in America by a Tyco Healthcare subsidiary as the IVS Tunneller in 2001, became the first transvaginal mesh delivery system cleared in America to correct pelvic organ prolapse in women.
The IVS Tunneller became the “predicate case” relied on by some of the world’s biggest drug companies to have transvaginal mesh kits “cleared” for sale in America over the following decade to treat prolapse, without independent clinical evidence of safety.
This was despite the IVS Tunneller being developed for incontinenece, and not prolapse. The 2001 clearance has subsequently been heavily criticised.
More than 100,000 American women have registered for legal action against transvaginal mesh manufacturers in America, and 750 women have registered for class actions in Australia against two American mesh manufacturers.
In February Victorian Senator Derryn Hinch successfully argued for a Senate inquiry into how transvaginal mesh was cleared for use in Australia, and the impacts on Australian women. He compared the transvaginal mesh scandal with the Thalidomide drug scandal in the 1960s.