Mesh Medical Device News Desk, July 12, 2016 ~ Failed Pelvic Mesh to be Used to Lift Breasts
According to its patent application, a controversial polypropylene plastic pelvic mesh, that is banned for sale in both the U.S. and Australia and is the subject of litigation, may find new life with a new application – for use as a lift for sagging breasts.
TFS or Tissue Fixation System is a pelvic mesh implant made by TFS Surgical of Australia that was approved a decade ago to treat incontinence and pelvic organ prolapse. The mini-sling uses up to five sets of mesh and barbed tissue anchors to shore up sagging organs.
TFS was created by Australian surgeon and urogynecologist, Dr. Peter Papa Petros, 76, one of the founding fathers of pelvic mesh.
Collaborating with Dr. Ulf Ulmsten MD, in the 80’s and 90’s, they created the original TVT (tension-free vaginal tape), approved for use in the U.S. in 1998, which served as a “substantial equivalent” predicate for dozens of pelvic mesh inventions that followed.
In 1990, they wrote about their Integral Theory.
Vaginal prolapse is due to a “lax vagina” they theorized. Therefore an implanted foreign body creates sufficient scar tissue to form a stable matrix that reinforces the sagging pubourethral ligament, part of the structure around the urethra important for urinary continence.
Its scientific principles established the foreign body reaction and formed the basis for the approval of generations of polypropylene pelvic mesh implants, developed, sold and implanted in hundreds of thousands of women as it says todaya on the TFS surgical website.
Here is the link for TFS System as it exists on the TFS website today.
The Integral Theory” set the foundation for a new approach to treatment of female pelvic floor dysfunction.
i.e. “repair the structure, and you will repair the function”
It’s the same theory that is now being applied to the cosmetic breast lift surgery.
The American Society of Plastic Surgeons says the breast lift procedures have grown 70% since 2000 and are now outpacing breast implants 2-to-1.
TFS has New Life as Breast Lift
The ideal patent application is as broad as possible for many applications.
That way materials can be changed and still considered compliant with the patent.
TFS had new life in a patent by Dr. Petros. Patent application no. 2015227399, (here) was filed a year ago but made public last May.
“A Method of Performing a Mastopexy Procedure” relies on the loose ligament theory. Mastopexy is the surgical correction of ptosis or sagging of the breasts. It can apply to both male and female patients. A foreign body reaction in the breast is the foundational theory for the breast lift procedure.
The TFS “Anchoring Device” would give breasts renewed lift, added life. If sagging pelvic muscles happened with age and multiple child births and compromised collagen and elastin, so too were breasts sagging in aging women. Why not use the “Anchoring Device” to introduce a new lift and new life into sagging breasts?
The patented method promises “the filament works like a brassiere to support the weight of the breast tissue, preventing further elongation due to gravity.”
The patent applicant is Dr. Peter Petros and former professional Australian athlete, Paul Zadow, who bought TFS Surgical from Petros.
The material is not referenced, only an unnamed “filament” will be used. The TFS (Tissue Fixation System) patent number is named within the new application and the image is the same in the 2004 patent by Dr. Petros for the TFS Anchoring Device.
The patent application does not require any proof of safety and efficacy. Instead it is a design and an idea and intellectual property.
Patent applications are published and advertised globally. After 12 months, if it is not challenge, A Method of Performing a Mastopexy Procedure, will be patented and can gain global registration approval in one year.
With that comes the profits and the recognition.
A History of Failure and Rebirth
TFS the Tissue Fixation System will be Dr. Petros’ third try at improving women’s health with untested synthetic implants.
The first was the TVT.
In September 1986, Mersilene prototype intravaginal sling, IVS, a tension-free operation was inserted in the position of the pubourethral ligament. Two women had a return of their continence without the need to catheterize. Six weeks later the tapes were removed. Ten years later, they were still continent, the inventors said in published reports.
At Royal Perth Hospital in Western Australia between 1988 and 1989 thirty operations were performed using the adjustable Mersilene sling at mid urethra. Most of the patients remained cured of their stress incontinence. By 1996, Dr. Petros had replaced Mersilene tape, because of the relatively high rate of erosion, with polypropylene mesh. This research was the basis of their Integral Theory developed in 1990.
Dr. Ulmsten, working at the University of Uppsala in Sweden, went on to pioneer the TVT.
Not surprisingly, Dr. Ulmsten attained the benchmark testing requirements laid out by Ethicon, which bought the patent for TVT from Dr. Ulmsten at a reported compensation rate of $25 million.
Dr. Ulmsten died at the relative young age of 66 on March 4, 2004. In the literature, Ulmsten is listed as the father of TVT.
Little is written about the collaboration between Ulmsten and Petros and whether theirs was a contentious falling out. MND has requested an interview with Dr. Petros which has gone unanswered so far but remains an open invitation.
Dr. Petros continued with innovations. His creation, the IVS Tunneller (IVS) was the first predicate for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Approved by the FDA in 2003, IVS was sold to Tyco, which later became Covidien then in 2015 was purchased by Medtronic.
Because of the high rate of complications with POP mesh kits, the FDA earlier this year decided to reclassify them to a high-risk device or class III. Meanwhile most manufacturers have removed theirs from the market rather then spend the millions necessary to now reach the benchmark required of clinical trials.
Calling it a “major advance” over the existing TVT (tension free vaginal tape), Dr. Petros theorized the Tissue Fixation System (TFS) could repair any ligament or fascial defect in the pelvic floor. TFS operations were called more “anatomical and far less invasive and were able to be performed under direct vision” rather than a blind procedure.
Up to five set of the device could be implanted in the pelvis. Including barbed anchors. Unfortunately, according to reports in medical journals, the anchors tend to separate from the mesh migrate through the pelvis”
The TFS was the first mini-sling, registered in the US via the 510(k) process in 2005. No clinical trials need be performed, just an exchange of paperwork to seek a clearance to sell.
One year later TFS was approved by the TGA, the Australian version of the FDA.
What Happened to TFS
In January 2016, the U.S. Food and Drug Administration (FDA) barred TFS from import into the US after regulators found it had changed its design twice.
TFS had already been de-registered for use in Australia in 2014 by the Therapeutic Goods Administration (TGA) similar to the FDA, after failing to provide evidence of its safety.
TGA announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products.” TFS could reportedly not provide clinical proof of the device’s safety and efficacy.
It was the first pelvic mesh to be de-registered by the TGA after it reviewed 60 different mesh devices for sale in Australia.
In a further crackdown, TFS Surgical was ordered by the Australian government to remove all of its pelvic mesh advertising with claims like “Safe & Effective,” and “A Cure for Prolapse,” and “Proven Performance.”
The FDA took its action on TFS after an accidental discovery.
In January 2012, the agency ordered all 33 manufacturers of the larger mesh used to treat pelvic organ prolapse (POP), to undertake three years of post-approval monitoring known as 522 studies, named for the code in the FDA regulation. See Mesh News Desk story here.
Sometimes a 522 study is ordered when a device has been shown to have problems after being cleared through the fast-track, 510(k) approval to sell process. Instead of testing before approval, tests are required after marketing when real life complications begin to emerge.
At that time, TFS Surgical advised the FDA it had had stopped selling their 2005 approved pelvic mesh device. Instead it had been redesigned at least twice, in 2009 and again in 2010. The implant reportedly underwent major revisions – the mesh type, dimensions, elasticity, porosity, essentially the new TFS was a completely different medical device from its 2005 prototype.
But TFS Surgical had never filed a new 510(k) application with the FDA.
Determining that TFS had been distributing “unapproved “pelvic mesh devices since around 2009, the TFS System made the list of an Import Alert barred from import into the U.S. in January 2016. The official reason stated by the FDA was for “Failure to Meet Device Good Manufacturing Practices.”
TFS never had complications reports entered into the MAUDE database of the FDA.
TFS Surgical is barred from making any new supplies of the device but a recall was never issued in either country. That means existing supplies can still be used.
According to a May 14, 2014 letter from TFS Surgical’s head, Paul Zadow to Nathan S. Ivey who headed the 522 Postmarket Surveillance Studies program, “We are no longer manufacturing or selling this product and have not been since 2009. We will not sell this product in the U.S. in the future.”
TFS Manufacturing, an Australian company, and TFS Surgical, based in Texas, is appealing de-registration.
TFS Litigation Gets Underway in AU and the US
The de-registration and U.S. ban is when the lawsuits began.
Last May, the newsmagazine in Australia, Lateline, ran a story on Barb Jobson, an Australian woman implanted with the TFS System. Her doctor says the anchors cannot come out due to a risk of hemorrhage. A doctor who is dealing with mesh complications predicts there will be thousands of product liability lawsuits resulting from complications he is treating.
In a response, TFS said its product is safe when used “by skilled surgeons trained in its use.”
The first case filed in the US emerged from TFS pelvic mesh surgery at a major center with Dr. Petros in attendance.
Proper vs TFS Surgical and TFS Manufacturing (Case no. 1:15-cv-01771 DAP) was filed in federal court in Cleveland, Ohio September 1, 2015.
Dr. Howard Goldman, MD of the Cleveland Clinic was Ms. Proper’s surgeon, according to court documents, and Dr. Petros was in the operating room and supervised the procedure. The state of Ohio’s recognizes Dr. Petros’ certificate for an active “clinical research faculty” certificate from the Ohio State Medical Board.
Two days after her August 5, 2013 procedure, Ms. Proper was readmitted to the hospital with nausea, vomiting, abdominal pain and vaginal discharge. A exploratory surgery found infection and evidence of stool contamination. The mesh was removed except for the right uterosacral ligament anchor, which could not be found.
In its Answers to her complaint, TFS Surgical denies Dr. Petros “supervised” the procedure.
Witt vs TFS Surgical and TFS Manufacturing (Case no. 0:2016-cv-01042) was filed in federal court in Minnesota for damages, April 21, 2016.
Both cases allege design and manufacturing defect, negligence, a failure to warn, defective product, breach of express warranty, breach of implied warranty, fraudulent concealment, constructive fraud, negligent misrepresentation, infliction of emotional distress.
The Proper case adds counts of violation of consumer protection laws in the state of Ohio, unjust enrichment, loss of consortium and asks for punitive damages.
From Hernia to SUI to POP to Breasts
The new patent application is for an unproven medical device allegedly invented by professional athlete, Zadow, a “former Newcastle Falcon basketballer and Australian representative player.” See the Newcastle Herald story here.
There will be no registered trials to test the Integral Theory and its application to lifting sagging breasts. But look at its history.
Just as the theory went, if polypropylene mesh works for hernia repair it should address pelvic floor prolapse in women. If the mini-sling works for SUI it should work for POP, all based on the Integral Theory.
Never mind there are hundreds of thousands of lawsuits alleging defective product, many mesh devices have been found defectively designed, there remain no requirement by the FDA for safety and efficacy and under the 510(k) clearance no clinical trials will be required.
The breast lift patent application #2015227399 is open for “Oppositions, Disputes & Amendments” before it becomes viable. You can dispute a patent on the grounds you invented it first, not on the basis of questions of safety.
Mesh removal surgeon, Dr Una Lee, tells MND in an e-mail, “I am concerned.”
Surgeon John Miklos writes in an e-mail, “It will be difficult for me to assess as the breast is not my area of expertise. Based upon the history of mesh complications in the vagina it is obvious extensive research should be done prior to teaching surgeons on how to use mesh in breast support. To do so otherwise would be gross negligence.”
Then again, maybe support of sagging breasts by scarification and plastic mesh support of ligaments will finally be the successful application that the inventor of the TVT has so long sought. #