THE Australian Therapeutic Goods Administration (TGA) has a database where the public can view adverse reports made about medical devices since 2012.
Because an adverse outcome might be the fault of a device, or the surgeon, or a combination of the two, or neither, the Database of Adverse Event Notifications carries a warning.
“Please do not make an assessment about the safety of a medical device based on the information in the database,” it says.
Six adverse reports appear on the database if you type in the words “TFS Manufacturing”, which produces the Tissue Fixation System transvaginal mesh prolapse device.
The device was developed by Dr Peter Petros who was sole director of TFS Manufacturing from May 2004. It was approved in Australia in October 2004, registered in 2006, and cleared for sale in America from May 2005. In July 2009 Dr Petros resigned as director and former Newcastle Falcon basketballer and Australian representative player Paul Zadow became sole director.
The TFS medical device, in the hands of skilled surgeons, brings enormous benefit to many women ...TFS director Paul Zadow
Two of the adverse TGA reports were sent by patients, and four by health professionals.
The surgeon who carried out the procedures, Dr Richard Reid, is the subject of a Health Care Complaints Commission investigation. He is prohibited from carrying out major surgery after the NSW Medical Council suspended him in 2014, and placed conditions on his practice after he successfully appealed and was reinstated.
Dr Petros is also the subject of a Health Care Complaints Commission investigation.
The adverse reports for the TFS Manufacturing device, recorded between January and October 2014, note the following: “Severe complications and ongoing medical issues including multiple surgeries following insertion of TFS system”; “Nerve entrapment, mesh pain syndrome, pelvic floor muscle spasm”; “This patient has chronic pain after TFS insertion. The implant was inserted unusually high, with anchors possibly impinging on the pudendal nerve or its branches. The patient has chronic pelvic/ back/ leg pain after TFS insertion, and prolapse recurrence”.
The adverse events continue: “One of the implants was placed unusually high, likely close to the pudendal nerve and/ or its branches. Chronic pain syndrome after placement of TFS tapes”; “Multiple devices used for incontinence and prolapse surgery. Several attempts by implanting surgeon at removing parts or all of these implants later due to multiple complications”.
TFS Manufacturing was one of the first companies to have its mesh device deregistered by the TGA in November 2014 after the TGA responded to rising concerns about all transvaginal mesh devices on the Australian market.
It deregistered the TFS device after deciding the company had failed to substantiate how it complied with relevant standards. TFS Manufacturing’s appeal to the Administrative Appeals Tribunal is ongoing.
In a statement on Thursday Zadow said his company “maintains that the TFS medical device, in the hands of skilled surgeons, brings enormous benefit to many women in Australia and around the world”.
The withdrawal of the device from the American market in August 2015 was a commercial decision and “was not based on any safety or regulatory issues”, he said.
In January this year the US Food and Drug Administration reported only five mesh devices remained on the market, from a high of more than 60 in 2011.
In April last year – and after tens of thousands of American women had launched lawsuits against mesh device manufacturers, and hundreds more in Australia were in a class action against mesh manufacturer Johnson & Johnson - Carol Proper of Ohio became the first American woman to launch civil action against TFS Manufacturing and the Texas-based arm TFS Surgical.
In a Cuyahoga County Court of Common Pleas complaint she alleged she had been “injured catastrophically” after mesh surgery using TFS in August 2013, and that Sydney-based Dr Peter Petros, who developed TFS, “supervised” her surgery. Dr Petros did not respond to a Herald request for comment and TFS Surgical denied Dr Petros “supervised”.
Proper alleged she was not appropriately advised of the “experimental nature of this procedure, and that there were safer treatment alternatives”, was not appropriately warned of the risks, and underwent surgery two days after her operation to remove the TFS sling and all but one of the anchors securing the mesh to her body because of pain and infection.
She alleged defendants TFS Manufacturing, and the Texas-based firm TFS Surgical (US) Inc, took part in “aggressive” marketing to health care providers, doctors and directly to the public, offering “exaggerated and misleading expectations” of the product’s safety.
Proper also alleged TFS, through its physician training program, “provided physicians with the comfort that they had sufficient training to minimize or eliminate adverse effects resulting from the devices”.
In its response to the complaint TFS Surgical denied the device was defective, or the existence of “safer treatment alternatives”.
The company admitted marketing the product to health care professionals, but denied “aggressive marketing” at medical conferences, hospitals, or private offices.
It admitted running a website, but denied it was “direct to consumer advertising” or part of a “multifaceted marketing campaign”. The company also denied “offering exaggerated and misleading expectations” about the device’s safety and utility.
In his statement on Thursday Zadow confirmed that TFS Manufacturing and TFS Surgical were subject to an ongoing legal claim in America initiated by Proper.
”TFS strongly refutes Mrs Proper’s claim, and is defending the claim. TFS denies that it is the cause of any issues suffered by Mrs Proper,” he said.
An Australian Register of Therapeutic Goods (ARTG) public summary of TFS Manufacturing’s registration of the TFS mesh device on October 30, 2006, says the device’s intended purpose is “the placement of synthetic mesh tape to cure female urinary or faecal incontinence and vaginal prolapse”.
The company’s use of the word “cure” in the ARTG application was the subject of a complaint to the TGA from a patient advocate in August 2014.
“By listing the intended purpose of the device as a ‘cure’ in the ARTG register, this is a statement to the public that the product is validly registered and accepted with that purpose,” the complaint said.
“This ARTG registration also suggests there is accepted scientific evidence which supports this claim of a cure.”
The ARTG public summary showed a registration application was made on October 13, 2006 and approved 12 working days later.
The TGA has not responded to a Newcastle Herald request for information about the process used by it to approve the device, or the scientific evidence relied on to register it for use on the Australian market.
In a paper in 2012 Dr Petros, who developed the Tissue Fixation System prolapse device based on his 1990s “integral theory”, described the mesh implant field for prolapse surgery as “a free for all”.
“See one, do one, teach one,” he said, in a paper describing “serious problems” with early mesh devices including “bladder perforation, injury to major blood vessels, nerves, small bowel and large haematomas”.
In a 2004 damages case Dr Petros was criticised by a West Australian district court judge for failing to warn a woman his “integral theory” to treat urinary incontinence and prolapse was “not a standard procedure… and was not employed by a majority of gynaecologists”.
The judge found Dr Petros lacked “a complete understanding of the obligation owed by a medical practitioner to a patient” before awarding a woman more than $136,000 in damages.
Dr Petros was “more concerned to extol what he perceived to be the many advantages of [his] procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and risks”.
In July 2014 the American TFS Surgical website said the “integral theory set the foundation for a new approach” to female pelvic floor dysfunction and its Tissue Fixation System was “in keeping with this theory”.