Tissue Fixation System (TFS) Lawsuit

An Australian Pelvic Mesh Company is being sued by US patients who claim its tape to treat Pelvic Organ Prolapse is defective. The product is a mesh tape called TFS, or tissue fixation system, which has allegedly caused the same complications as transvaginal mesh products made by medical device companies in the US and in Europe.

Australian newspaper The Newcastle Herald (Aug 18, 2015) reported that the tape has been withdrawn from use in Australia. Lawsuits have been filed against TFS Manufacturing Pty and the Texas-based firm TFS Surgical (US), claiming the medical companies aggressively marketed the "Tensioned Mini-Sling with Anchors"to health care providers, doctors and directly to the public, and offered "exaggerated and misleading expectations"of the product' safety. For instance, the tape is marketed as:

• "Minimally Invasive,"which is misleading and deceptive; Medical literature shows at least 10 percent of mesh surgery results in erosion and serious complications.
• A "Cure for Pelvic Organ Prolapse,"which is not supported.
• "Mesh"or "ling"rather than transvaginal mesh, which is associated with severe complications.

  A product liability lawsuit was filed in the state of Ohio in August 2015 by a US woman seeking a jury trial. Carol Proper was implanted with a pelvic mesh or sling product called the Tissue Fixation System during surgery performed in Ohio in 2013.

According to Ohio court documents, Carol Proper, along with her husband James Proper, claims that she has permanent injuries due to complications that arose after TFS mesh and anchors were implanted in her pelvis, which included having a section of her small bowel removed after it had been perforated. She was suffering from severe nausea, vomiting, abdominal pain and vaginal discharge and was re-admitted to hospital two days after the mesh was implanted. The mesh was removed due to infection in the area but the surgeons were unable to obtain one of the "anchors"- part of the TFS.

(The Australian newspaper reported that Peter Dietz, a professor of obstetrics and gynaecology at the University of Sydney' Medical School Nepean, said the "TFS tape is more likely to erode and the barbs on the anchors can be dangerous when placed in sensitive areas that are rich in nerves and vessels.")

The TFS lawsuit further claims that the woman was "not appropriately advised regarding the experimental nature"of the company' "tissue fixation system"for treating pelvic organ prolapse (POP).

The Propers' claim states that TFS Manufacturing and TFS Surgical (US) "failed to perform or rely on proper and adequate testing and research in order to determine and evaluate the risks and benefits of the defendants' pelvic mesh products."

On its website, the TFS manufacturer describes its product as tape, but according to how the mesh is made and its application for approval, it is indeed transvaginal mesh. Carol Proper argues that by omitting the word "mesh"from its advertising and marketing, given the high level of public awareness and global warning of the failures, dangers and complications associated with use of "Mesh in Prolapse Surgery,"the advertisement was misleading consumers by omission [of the word transvaginal].

The Australian Financial Review (May 26, 2015 ) reported that the TFS tape has been withdrawn from use in Australia. A spokeswoman for the Therapeutics Goods Administration (the Australian equivalent of the FDA) said the tape "was cancelled because the sponsor failed to provide evidence to demonstrate compliance with standards for safety and performance."In other words, the tape has been taken off the shelf because there is insufficient evidence to demonstrate that TFS is safe.

TFS is the first "Tensioned Mini-Sling"mesh device that utilizes a barbed plastic anchoring system. It was registered by the Australia' Therapeutic Goods Administration (TGA) in 2006.

TFS Manufacturing in November 2014 had its mesh product deregistered (meaning it can no longer be sold or exported) by TGA after it failed to substantiate how its "tissue fixation system"complied with relevant standards. More TFS lawsuits are expected to be filed in the US.
 

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Last updated on Oct-29-21