How a request for updated safety information on surgical mesh devices turned into a two-day ordeal. Teuila Fuatai reports.
Implementing solutions to a decade-long medical saga that has already cost taxpayers $13 million in injury payments appears to be a non-priority for health officials in 2018.
As far back as 2008, post-surgery problems with transvaginal mesh procedures were flagged with ACC. Initially, only 14 people who underwent repair surgery for either incontinence or pelvic organ prolapse, and were implanted with surgical mesh, were identified as suffering unexpected and severe complications between 2005 and 2008.
Ten years later, a slew of injured patients impacted with life-debilitating injuries due to surgical mesh implants have hit headlines around the world, with various jurisdictions, including Scotland and Australia, undertaking official inquiries into the product. Class-action suits involving hundreds of women have also been launched against product manufacturers, and some health authorities, in Australia, the US and the UK.
Locally, New Zealanders have not escaped the damage either. Latest ACC figures show in the 12 years to June 30, at least 800 injury claims relating to surgical mesh have been lodged. Injury payouts totalled $13.2 million in that time.
Despite this, and a major Ministry of Health announcement in December which effectively limited and even removed the use of some surgical mesh products used for gynaecological procedures, follow-through into the new year has been severely lacking.
Over the past two days, Newsroom has tried to obtain an update from the Ministry — which is responsible for the country’s therapeutic goods watchdog Medsafe — over whether mesh supply companies have adhered to its December 11 announcement requiring safety information for products in New Zealand.
The announcement followed changes imposed by Medsafe’s Australian counterpart, the Therapeutic Goods Administration (TGA), after it reviewed surgical mesh products. While the Australian legislation dictated companies had 20 working days to adhere with the the TGA’s new safety requirements — enacted on November 28 — New Zealand’s Medicines Act allows companies 45 days.
That deadline lapsed on Thursday, January 24.
After a series of phone calls, emails and texts between Newsroom and the Ministry — carrying on from Monday into Tuesday — not even the request of confirming whether mesh supply companies had submitted safety information during the 45-day period was answered by Ministry officials. Notably, in its December announcement, the Ministry stated it had been in contact with four companies which supplied the local market.
“Medsafe is using powers under the Medicines Act 1981 to require suppliers to provide safety information about their devices.
“Under section 38, Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd requesting safety information or confirmation that the companies will comply with the Australian requirements.
“Medsafe understands from its communications with these companies that they intend to comply with the requirements by 4 January 2018,” the Ministry said at the time.
Initially, Newsroom was told to place its query under the Official Information Act (OIA) — a process which can take up to 20 working days for a response. When this was contested on the grounds that the information “should be readily available as it is concerns medical devices currently on the market”, the Ministry then said the information could be “commercially sensitive”, and officials required the timeframe enabled under the OIA to review it.
Meanwhile, The TGA website has had updated safety information on various mesh devices since December 22. A further update was loaded onto the site on January 4.
By early afternoon Tuesday, a Ministry spokesperson told Newsroom an official statement in response to its query would be sent in about 30 minutes — however that never came through.
Instead, an email at 3.55pm came through which stated: “the Minister’s office will be in touch with you”.
Associate Health Minister Julie Anne Genter — who only took over the surgical mesh portfolio in December — said yesterday she had not been briefed on the matter.
The latest set of actions from the Ministry have disappointed those injured by surgical mesh.
Carmel Berry, co-founder of the 500-strong patient advocate group Mesh Down Under, said they had been trying to work with relevant medical colleges to produce a “comprehensive patient information brochure”.
“We need to know which products are to remain available for use in New Zealand to ensure that this brochure is current and accurate.”
Charlotte Korte, who founded the group in 2012 with Berry, called for clearer systems: “We feel that due to the gravity of the surgical mesh issue it is important for the government to show that transparency is of the utmost importance”.
Update: Products removed from the Australian register no longer supplied in New Zealand
At 10.30am this morning, Medsafe announced it had heard from the four companies it contacted as a result of the TGA review.
“All four companies contacted have responded and have confirmed that all products removed from the Australian register are no longer supplied in New Zealand,” Chris James, group manager at the authority said.
According to the announcement, affected products are those used only for repair of pelvic organ prolapse. A single incision mini-sling product, used to treat stress urinary incontinence, was also identified as no longer in supply in New Zealand.
Medsafe also said it was working with companies that needed to update “instructions for use” for mesh products, and had not yet completed the process.
In total, nine surgical mesh devices from three companies were listed as “no longer supplied in New Zealand”. No products from Johnson & Johnson were listed.
