New Zealand Restricts All Transvaginal Mesh Implants

from Radio New Zealand

Mesh Medical Device News Desk, December 12, 2017 ~ Whether petitioning Parliament, partaking in on-camera interviews or newspaper stories, anti-mesh campaigners from around the world are seeing the results of their efforts.

The new restrictions on transvaginal mesh implants are the result of greater awareness on the part of the public and front-page news headlines.

New Zealand has gone one step further than any other country in its attitude toward the controversial polypropylene transvaginal mesh.

Early next year, New Zealand will restrict the use of all transvaginal mesh implants- those used to treat stress urinary incontinence (SUI) as well as pelvic organ prolapse (POP).

That means the small island nation is going one step further than its nearby neighbor, Australia, which announced last month, a ban on the use of mesh for POP only.

Hernia mesh, made of the same polypropylene plastic, is not included in the ban, even though many complain the implant mesh has left them with life-altering injuries as well.

The regulatory agency, Medsafe, similar to the U.S. Food and Drug Administration (FDA), will required four companies provide assurances safety about the safety of their devices.

Boston Scientific NZ, Johnson & Johnson Medical NZ, Culpan Medical, and Endotherapeutics NZ, both medical device suppliers, will comply with the requirements by January 4, 2018, according to a Medsafe news release here.

Carmel Berry, founder of the Mesh Down Under campaign, appeared on Radio New Zealand Monday morning. The group has been pushing for a ban since 2014.

“This is a complete about face and validation to what we’ve been saying all along is true. It shouldn’t have taken health officials this long….all the evidence we supplied obviously wasn’t enough…”

The health ministry now says there is enough evidence that the benefits of transvaginal mesh do not outweigh the risks. That is based on a PROSPECT study (here) released last year in the UK which came to the same conclusion after reviewing the results of more than 1,300 surgical procedures using either native repair (one’s own tissue) or a mesh graft.

Regulators in both Australia and New Zealand typically follow the lead of the FDA, which like Australia, is putting restrictions only on the larger POP mesh, used to treat pelvic organ prolapse.

In the U.S. the FDA gave POP mesh makers 30 months, beginning last January, to assure the safety of the larger polypropylene mesh implants or remove them from market. That period will end mid-2019. See MND story here.

The FDA has the authority to recall drugs and medical devices and consumer products, but more often asks for a voluntary removal from market. That move avoids protracted litigation.

New Zealand resembles the U.S. in that it does not require clinical trials before a manufacturer can sell its medical devices.

Product Liability

Unlike the U.S. where product liability lawsuits address defective products, the government pays claims of the injured under ACC, the Accident Compensation Corporation.

ACC has paid $13 million in claims of chronic and infection to more than 800 patients over a dozen years, it was revealed last October.

ACC claims are the only way the government assesses complications as there is no national registry for mesh devices, something campaigners say is vitally needed to get some sort of handle on the actual number of injured patients.

The U.S. also has not definitive device registry, though medical records are supposed to contain a tag to identify the lot number of a medical device.

Abbrevo from Ethicon brochure

Products Affected

Products that will be affected include Boston Scientific Uphold Life, Solyx, Obtryx, Lynx, Advantage, Upsylon and Zenform Soft Tissue Repair.

Cuplan Medical’s Coloplast and its nine models. The TVT family of meshes from Johnson & Johnson including Gynemesh PS, TVT, TVT-O, Abbrevo, and Exact, the same type of mesh implanted in late campaigner from Canada, Chrissy Brajcic.

Doctors Weigh In

Dr. Hanifa Koya on Radio NZ

As one might expect, there is dissent among some medical doctors who still want the option of using a “sling” or “tape” as SUI mesh is often referred to.

Speaking on Radio NZ, gynecologist, Dr. Hanifa Koya, says she is in agreement with restrictions on POP mesh but she wants Medsafe to reconsider its “blanket rule “ ban on surgical mesh, which she uses to refer to SUI tape, a smaller piece of the same polypropylene mesh.

Dr. Koya says she used retropubic sling mesh for 21 years with a high success rate. Australia has not removed the incontinence sling and we should not either, she says.

Complications from a SUI polypropylene mesh are estimated to be a minimum of 15%, according to one report,

She does not feel the same way about SUI mesh that passes through the obturator space, also known as TVT-O mesh.

“The transobturator goes thru the groin and 20 percent of women suffer leg and groin pain,” she tells Radio NZ.

Dr. Hoya has observed that no single surgeon does vaginal repair the same way and that’s part of the problem. She has done 75 complicated mesh removal surgeries and wants to teach others how to do implants safely.

IUGA Lynsey Hayward

Also speaking on Radio NZ, International Urogynaecological Association president Lynsey Hayward, insists that SUI mesh is absolutely fine, she said, calling stress urinary incontinence an “extremely disabling condition.”

That’s the same language that jurors in the U.S. hear from defense attorneys at transvaginal mesh trials.

Hayward says the “tapes” that are used for urinary incontinence are safe and well-studied and the most widely used retropubic tape (also called a TVT), is used internationally, the majority of time very successfully.

Carmel Berry and Charlotte Korte

AUSTRALIA

Last month, Australia’s Therapeutic Goods Administration banned surgical mesh implants for pelvic organ prolapse (POP), but left alone the meshes used for stress urinary incontinence (SUI).

Mesh Down Under’s Carmel Berry says the government’s position that SUI mesh is safe “when used in accordance with the manufacturers’ instruction by an appropriately trained surgeon,” should be removed from the website. Instead they should say new information shows that was wrong.

The ban applies to POP mesh and single incision mini-slings such as the TVT Secur (discontinued in March 2013), to treat SUI.

Outside federal court, Sydney, AU

The class action lawsuit filed by 700 women continues in a Sydney, Australia courthouse against Johnson & Johnson and its Ethicon division.

The case may wrap up this month. ###