Preview Newsletter
Ethicon 11/8
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Drs Raz and Ackerman: Risks and Benefits Lacking for Slings
Nov 7, 2017 | Mesh Medical Device News Desk
This well thought out opinion piece is voiced by two leaders who are well acquainted with the devastating injuries resulting from women implanted with mesh, “slings” and transvaginal mesh, used to treat incontinence and prolapse. -
FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh
Nov 7, 2017 | Mesh Medical Device News Desk
It’s been more than a year since it was notified, but now the U.S. Food and Drug Administration (FDA) says there are no worries with the pelvic mesh made from raw polypropylene sourced under questionable circumstances from China by Boston Scientific (BSC), a major mesh manufacturer. -
Therapeutic Goods Administration rejects claims it is 'too close' to medical industry
Nov 8, 2017 | The Guardian
By Melissa Davey
Australia’s drugs and medical devices watchdog has denied it is too close to the industry or that receiving funding from health and medical companies is a conflict of interest, after its independence was questioned by health experts.
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Drs Raz and Ackerman: Risks and Benefits Lacking for Slings
Nov 7, 2017 | Mesh Medical Device News Desk
This well thought out opinion piece is voiced by two leaders who are well acquainted with the devastating injuries resulting from women implanted with mesh, “slings” and transvaginal mesh, used to treat incontinence and prolapse.
Writing in the International Brazilian Journal of Urology, in July-August 2016 is an Opinion Piece (here) by Dr. A. Lenore Ackerman and Shlomo Raz MD.
The authors, from Cedars-Sinai in Los Angeles and UCLA, say about half of all women will have some component of stress urinary incontinence in their lifetime and about 10% will undergo a surgical treatment.
A. Lenore Ackerman, MD PhD
As opposed to years past when the Burch colposuspension or autologous fascial pubovaginal sling was the norm, augmented polypropylene (PP) products have been adapted for medical use to become the preferred synthetic midurethral slings (SMUS) for the treatment of stress urinary incontinence (SUI).
By 2010, the SMUS was the standard of care worldwide because of the reported equivalent outcomes with Burch and fascial slings, their ease of use, faster recovery time and reduced cost.
PP mesh used for pelvic organ prolapse (POP) then followed, however, soon severe complications came to light and the first black box warning was issued by the FDA in 2008.
The more serious warning followed in 2011 (“complications are not rare”), and in January 2016 the FDA upgraded the alert on POP mesh moving it from a moderate risk class II to a high risk, class III.
At the same time, SUI mesh remains in class II or moderate risk even as more than half of the hundreds of thousands of lawsuits have been filed against SUI mesh alleging its defective.
At UCLA, of the nearly one-thousand patients seen over the past five years for TVM (transvaginal mesh) complications, 77% were related to the mid-urethral sling.
More than half of the adverse event reports filed with the FDA (MAUDE database) are associated with SUI repairs.
The FDA said it “continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report abut that usage at a later date.”
While true patient informed consent involves understanding the benefits, safety and efficacy, as well as risks and severity, “Both of these are lacking for SMUS”, say the authors.
CHRONIC PAIN
There are limitations in any dialogue regarding mid-urethral sling complications – dyspareunia, urethral and bladder perforation, vaginal scarring and stenosis, mesh extrusion, vaginal bleeding- have been discussed in the literature, but here the authors focus on chronic pain.
Chronic pain may not just be found in the groin area and reports of pain elsewhere often are not included in a risk/benefit analysis. Neither does chronic, debilitating pain that develops a year or more after implantation. There are no treatment plans for this type of pain.
Often women turn to a full or partial mesh removal but even with excision “approximately one-quarter of these patients will not improve or will even worsen, living with constant debilitating pain.”
FAILURE RATE
Almost everyone agrees that complications from synthetic mid-urethral slings are under-reported, but by how much?
Dr. J G Blavais estimates 15.3% will experience serious adverse event or a surgical failure. That number jumps to 25% or higher from a five-year trial of transobturator tape slings.
Transobturator mesh, from Scottish Pelvic Floor Network
Quality of life (QOL) issues such as cystitis, voiding dysfunction and neurologic symptoms are often dismissed in long-term assessments. Shame, hopelessness, regret, anxiety,and frustration, can result impacting personal relationships and creating self-image problems.
Failures may not be felt by the patient until years after an implant yet a recent Cochrane Review only addressed four outcomes after one year among 84 clinical trials. That means most of the data is short-term with limited clinical relevance.
The authors do not seek a ban on mid-urethral slings but only to highlight that little is known about the risks of mesh-augmented procedures in SUI management. Are the risks justified? Is there that much to gain by using synthetic mesh over a Burch colosuspension and autologous fascial sling?
Advocating SMUS as a quick fix for everyone may be growing the divide between patients and physicians and add to the emotional devastating of the injured patient.
“As a community we must take this public outcry seriously, acknowledge our lack of insight into these complications, and pursue a deeper understanding of the pathophysiology of poor outcomes after SMUS.”
The physicians argue that it may be time to return to bioethics and the “first, do no harm” when it comes to treatment. For an inconvenience like incontinence, it may be better not to do something rather than risk causing more harm than good.
https://www.meshmedicaldevicenewsdesk.com/drs-raz-ackerman-risks-benefits-lacking-slings/
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FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh
Nov 7, 2017 | Mesh Medical Device News Desk
It’s been more than a year since it was notified, but now the U.S. Food and Drug Administration (FDA) says there are no worries with the pelvic mesh made from raw polypropylene sourced under questionable circumstances from China by Boston Scientific (BSC), a major mesh manufacturer.
This update was issued from the FDA in mid-September. (See the 9-19-17 notice here and here.)
What does the FDA do when it finds convincing evidence that a major medical device maker has skirted the rules to source allegedly substandard materials from a known counterfeit smuggler in China?
According to the FDA, “After an extensive review of data and the results of testing the finished product, the FDA has determined that the change in supplier of the polypropylene used to manufacture Boston Scientific’s urogynecologic surgical mesh currently on the market does not raise new safety or effectiveness concerns.”
The FDA was alerted to the questionable raw polypropylene sourced and allegedly smuggled from a known counterfeiter in China with no assurances of authenticity by the Mostyn law firmof Houston, which is representing plaintiffs in a racketeering class action against BSC.
The questionable PP was made into transvaginal mesh implanted permanently in thousands of women who have joined the class.
When a material used to make a medical device is switched, FDA rules say it may not be the same medical device and should spark another application for clearance. That never happened here.
In January 2016, the law firm filed a motion before Judge Joseph Goodwin, overseeing the federal pelvic mesh litigation, to seek an injunction to stop the sale and implantation of the questionable BSC products.
Judge Goodwin then passed the issue onto the FDA for its review, and the FDA sought the expertise of Boston Scientific to “conduct additional testing relevant to the safety and effectiveness of the finished product,” leaving in limbo the approximately 55,000 women who’ve received the questionable products made by BSC after September 2012.
Mostyn law, in an April 2016 letter, strongly urged the FDA to take notice of the potential for substandard counterfeit raw materials as a violation of federal law and a threat to public health. It asks:
“Does the FDA believe equivalence is a defense to trafficking of counterfeit raw material in violation of the Trademark Counterfeiting Act?”
WHAT ASSURES THE FDA?
The FDA says it has relied on data and information supplied by Boston Scientific and its own testing on the finished pelvic mesh medical devices.
After conducting testing at the facilities involved in the manufacture of its urogynecologic mesh, collecting samples and reviewing mechanical performances, testing the final mesh devices and reviews of the chemical biocompatible and mechanical performances, the FDA found variability, “but determined, based on the information available to use, that these differences do not present new safety or effectiveness concerns, and do not require submission of a new premarket notification.”
After its own review, Mostyn law reported tests did show “significant differences” between the Chinese resin and certified Phillips Marlex.
The fibers were weaker and there was more selenium with different molecular strings indicative of substandard manufacturing, according to the racketeering lawsuit filed by Mostyn law on behalf of Teresa Stevens and a class of women implanted with the allegedly substandard mesh after September 2012.
Read the complaint here.
The FDA says it is not uncommon for a supplier to change the source of raw material used to make a medical device.
There is no mention by the FDA of the alleged attempts to conceal, ship and smuggle the counterfeit resin out of China and into the U.S. and Belgium, as discussed in inner-office emails produced in discovery that show attempts to conceal those activities.
Women implanted with BSC mesh are not recommended to have their medical devices removed, says the agency.
Meanwhile the racketeering lawsuit filed by Mostyn Law alleging trafficking in counterfeit polypropylene continues to add plaintiffs who were implanted with Boston Scientific transvaginal mesh produced after January 2012.
https://www.meshmedicaldevicenewsdesk.com/fda-finds-no-prob-boston-sci-chinese-counterfeit-mesh/
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Therapeutic Goods Administration rejects claims it is 'too close' to medical industry
Nov 8, 2017 | The Guardian
By Melissa Davey
Australia’s drugs and medical devices watchdog has denied it is too close to the industry or that receiving funding from health and medical companies is a conflict of interest, after its independence was questioned by health experts.
On Monday Dr Wendy Bonython from the University of Canberra’s Health Research Institute told Fairfax Media that the Therapeutic Goods Administration’s [TGA’s] industry funded model of regulation needed a complete overhaul,including “a clear break between the regulator and the parties they’re trying to regulate”.
Bonython said accepting fees from industry was unacceptable in the wake of the transvaginal mesh scandal that saw the TGA approve meshes for use in treating prolapse despite a lack of evidence for the safety and efficacy of the products. Thousands of women who received the meshes have reported complications including severe pain and damage to nerves and nearby organs, including the bladder and bowel.
On Tuesday Ken Harvey, a professor of public health and preventive medicine at Monash University, criticised a decision by the TGA to allow a supplement company to promote a herbal remedy as helpful in relieving the symptoms associated with an enlarged prostate, despite scientific evidence to the contrary. Harvey told Guardian Australia it was “another example of them [the TGA] being very helpful to industry while being ineffective from a consumer protection point of view”.
The criticisms prompted the TGA to release a statement on Wednesday saying it “totally rejects claims” of a “too close relationship between regulator and industry because of this funding model”.
“While fees received, for example, for the evaluation of a product are used to fund staff time on evaluation of that product, they are not refunded if the application is rejected or withdrawn,” the statement said.
“Industry has no say whatsoever in how TGA spends the revenue it receives from other industry charges. This system has been in place for more than 20 years and there has been no evidence of any sort of regulatory capture.”
In regards to transvaginal meshes, the TGA said it could only make decisions based on evidence available at the time. In 2008 an expert committee found the reported rate of complications from the meshes was low, with complications closely linked to the skill and training of the surgeon and the patient selection.
“So at that time it would have been inappropriate to implement some of the measures that have been introduced more recently,” the TGA said.
In October last year the TGA announced it was reclassifying transvaginal meshes as “high risk” following post-market reviews conducted in 2010 and 2013, and that this new classification and additional regulations around the devices would commence in December next year with a staged transition period. From July 2012 to 1 June 2016, the TGA received 99 adverse events reports involving urogynaecological surgical meshes, with pain and erosion the most frequent complaints. The TGA acknowledged adverse events were likely underreported.
“Other medicines and device regulators internationally also are fully or significantly funded by industry fees and charges and operate in the same way,” the TGA statement said. “This takes the burden off the taxpayer for such time-consuming scrutiny.”
But, in a complaint to the TGA, Harvey accused the regulator of being “disingenuous”.
“Regardless of whether the regulator is funded by industry fees or the government, the consumer pays, either through higher prices on therapeutic goods or increased taxation,” he said.
“Second, how many other therapeutic goods regulators are 100% funded by industry? The benefits of industry funding are that the regulator is not constrained by cutbacks in government budgets, efficiency dividends and other constraints. The downside is that industry has a greater say in how its fees are used and there is an increased risk of regulatory capture.”
https://www.theguardian.com/australia-news/2017/nov/08/therapeutic-goods-administration-rejects-claims-it-is-too-close-to-medical-industry
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