Pharmaceutical

People are asking how banned transvaginal mesh device TFS was ever allowed on the market

2012 TVM serious complications People are asking how banned transvaginal mesh device TFS was ever allowed on the market This week the Australian Broadcasting Corporation (ABC) on Lateline interviewed grandmother Barb Jobson about the devastating consequences of the Australian-made transvaginal mesh device that was banned just 13 months after she had her operation.

“There was no indication that there was going to be any problems. It was God’s answer to women,” Barb told ABC. She hadn’t been warned about any potential complications and the device had been advertised as proven safe and effective in spite of the fact that two years earlier medical experts had published a paper raising concerns about the product, known as TFS.

According to MSN the paper noted that five years into its use, there had not been a “randomised control trial.” TFS, or tissue fixation system, is a thin mesh tape device fixed inside the pelvic region with a barbed anchor at each end, in theory to mimic ligaments, support the organs again and cure pelvic organ prolapse. It was approved by Australia’s Therapeutic Goods Administration (TGA) in the mid-2000s without extensive testing under a rule that allowed it approval if it was substantially equivalent to other devices already on the market.

“We suspect TFS may result in more significant scarring, anchor/tape erosion and vaginal pain than the preceding trocar-designed procedures,” MSN reported the paper as saying. “We must approach the introduction of such devices with caution in light of these unfolding case complications.”

In response to complaints about TFS and other mesh devices, the governing agency in 2013 required “clinical evidence, risk analysis and post-market data” be submitted on all urogynecological devices, and in 2014, unsatisfied with data provided by TFS Manufacturing, struck TFS off its register.

Lawsuits are now underway in both Australia and in America, where TFS has now been banned from being imported, and patients are questioning how TFS was ever allowed on the market. A specialist interviewed on Lateline when asked: “So I guess you’re not surprised that the TGA and the FDA have both deregistered this device,” replied, “I’m surprised that it took so long.”

Professor Peter Dietz, who has treated more than a dozen women who’ve been implanted with this device, said, “The number of unusual complications that have arisen after implantation of TFS exceeds anything and everything I’ve seen in the past.” That includes 18-plus years of surgery. “As far as I’m aware as of today, there is no such trial that shows that the TFS actually works as a prolapse procedure,” Dietz said

“Does that surprise you, that this has been in use for at least eight years without any of this research to back it up?” asked Lateline.

Dietz replied, “Yes, it’s a disgrace.”

“TGA now has a higher expectation of what comprises adequate clinical data,” the agency explained in a letter obtained by Lateline. But that doesn’t change the fact that thousands of women like Barb Jobson were implanted with the device both in Australia and America during the decade it was on the market and they are living with the aftermath.

During the interview Barb discussed the chronic pain that she says followed the procedure. Within two weeks she said she began experiencing pain that keeps her from sitting for extended periods, but “Standing for too long, I feel like everything’s going to fall out,” she said. She also said the procedure caused months of incontinence. The anchors have become embedded and she’s been told that removal causes hemorrhaging and surgeons are unable to remove them.

“If I’m in the car, I have to ask my husband to stop. I have to get out,” she said…. “The pain I have now, I can do nothing about. Nothing I take or do takes it away.”

Sources:
ABC
MSN