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Ethicon Media Monitoring 3/8/2019
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Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
Mar 7, 2019 | Kaiser Health News
By Christina Jewett
Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. -
Major surgical mesh manufacturer Bard to pull vaginal implant products
Mar 7, 2019 | Sky News
By Charlotte Lomas
One of the main manufacturers of surgical mesh in the UK has decided to pull its products for vaginal implants. -
BD’s Bard pulls all pelvic mesh products from EU market
Mar 7, 2019 | Mass Device
By Fink Densford
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard is removing its women’s pelvic organ prolapse and stress urinary incontinence mesh devices from the European Market, according to a recently posted field corrective action from the company. -
BD withdraws surgical mesh products for SUI and POP
Mar 7, 2019 | Medical Plastics News
Becton, Dickson and Company has withdrawn its surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) – manufactured by C R Bard – from hospitals and distribution centres, with the company saying the move is part of its business strategy. -
Daughter of woman who suicided after mesh surgery wins legal battle against surgeon
Mar 8, 2019 | Newcastle Herald
By Joanne McCarthy
Pelvic mesh surgeon Richard Reid dealt a final blow to the daughter of a woman who took her life in 2015 following mesh surgery, after he tried to stop being "named and shamed" as her doctor. -
What's on your mind? What women in Canberra are thinking about
Mar 8, 2019 | The Canberra Times
By Sally Pryor
...I’m also surprised that the #MeToo movement hasn’t yet provided a groundswell of women’s action around healthcare issues, especially given high-profile cases concerning the Sydney gynaecologist, the Johnson and Johnson vaginal mesh case and more locally public letters from staff at the Canberra Hospital regarding the adequacy of maternal services. These issues are linked.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
Mar 7, 2019 | Kaiser Health News
By Christina Jewett
Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened.
The surgical stapler meant to cut and seal the tissue around the appendix locked up.
Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said.
Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did.
Such failures can have deadly consequences.
Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.
“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.
The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.
Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.
An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.
Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.
KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.
Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.
“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.
The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.
FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.
“I don’t want to sound overdramatic here, but it seemed like a cover-up.”
DR. DOUGLAS KWAZNESKI, SURGEON
Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.
Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.
More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.
The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.
To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.
“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”
Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy.
In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.
Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.
The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.
Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital in Ohio.
Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.
Told of the reporting “exemption” for surgical staplers, his wife, Doris Levering, was incredulous.
“Why would this information not be made available to doctors? The true information — I mean the actual numbers …” she said. “People’s lives are at stake. Mark’s life will never be the same.”
The Stapler Problem
The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.
Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.
The severity of some of the injuries caught former FDA official Brown’s attention in the early years of its reporting exemption. Her 2004 article on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the “alternative summary” program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.
She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a “reason for concern.”
In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.
Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.
In Michigan, Eugene Snook’s surgeon was in the process of removing part of his lung when he cut but couldn’t seal a major vessel due to a “stapler malfunction,” the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.
The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien’s control and also that the surgeon used it improperly.
The case reached a confidential settlement in 2017.
Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.
The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn’t prove that the stapler had a specific defect.
Covidien reached an agreement to settle the family’s claims for $250,000, part of a larger settlement in the case.
Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris.
That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.
Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.
After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.
Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark’s bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were “prudent, proper” and “lawful.”
Covidien denies any defect with the stapler or that it caused Levering’s injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that “we always make patient safety our top priority” and that the company complies with FDA requirements.
The company’s reports of stapler problems in the public database remain relatively low. But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien’s staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.
Rolling Out The Program
The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.
Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.
Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device manufacturers to propose a solution.
Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database.
The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.
That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.
“I don’t know why it’s not [made public] now,” he said. “I’m surprised about that.”
Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.
The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.
The FDA declined to provide a complete list of “about 100” devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.
An FDA spokeswoman said “alternative summary” exemptions remain in place for pacemaker electrodes and implantable defibrillators.
Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.
He said he regularly scans the FDA’s public device-injury reports. Asked about “alternative summary” reports, he said, “I’ve got to tell you, that’s a new term to me.”
Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he’s the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.
In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a “nothing burger,” but the data would be meaningful to his forensic investigations.
The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual “Top 10” in medical technology hazards. Its tagline: “Separating fact from fiction in healthcare.”
Among the institute’s “top medical device subject matter experts,” spokeswoman Laurie Menyo said in an email, “none of them had any familiarity with FDA’s Alternative Summary Reporting Program.”
Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. “Never heard anything about it,” he said. “It’s interesting.”
Companies that get the exemptions tend to be very “tight-lipped” about them, said Christine Posin, a former device firm manager and consultant to device companies.
The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what’s buried elsewhere.
That creates a business opportunity to persuade a doctor to try a different device. “‘We have a good product that does the same thing,’” Posin said a sales representative might tell a physician.
Exemptions Multiply
The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.
Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a “safety communication” saying “serious complications” like pain or infection were “not rare.”
The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.
Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.
Under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single placeholder “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits.
To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details on the 1,175 cases submitted directly to the FDA.
According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.
“The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.” – Madris Tomes, Former FDA Manager
Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is “horrible” and “unethical.”
“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”
The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a “haphazard” system that is “not independent and not transparent.”
Within months, the FDA allowed the makers of the robots to file a single report, noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches of 99 and 130 injuries at a time.
“This is very frustrating,” said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.
Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.
Under the “registry exemption,” device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz.
Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.
Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that’s snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve will last in the body.
The summary reports offer potential patients few answers. Such reports document as many as 297 deaths or 1,800 injuries in a single filing, with virtually no detail readily available to the public. In all, Edwards has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.
Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide “comprehensive evidence for device safety.”
“The approval of alternative reporting protects against duplicate reports coming from multiple sources,” Huoh said.
Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial, with some scientists saying it is crucial for a certain subset of patients, and others pointing to the harm it can cause to the heart.
The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many as 347 deaths or 1,000 injuries in a single filing, also shipping the details straight to the agency, FDA records show.
An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip’s safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.
“We need to know the good and the bad. If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.” – Dr. M. Tom Margolis, Urogynecologist and Expert Medical Witness
Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they’ll be filing a public summary report in MAUDE.
The FDA has deemed the makers of more than 5,600 types of devices eligible to file “voluntary malfunction summary reports.” Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves.
The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.
“It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”
https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
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Major surgical mesh manufacturer Bard to pull vaginal implant products
Mar 7, 2019 | Sky News
By Charlotte Lomas
One of the main manufacturers of surgical mesh in the UK has decided to pull its products for vaginal implants.
All mesh made by Bard used in stress urinary incontinence and pelvic organ prolapse surgery is being voluntary withdrawn from hospitals and distribution centres with a deadline of two weeks.
Bard owner BD said it "has decided to discontinue the manufacture and sale of pelvic organ prolapse and stress urinary incontinence products in all remaining markets worldwide".
"While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements."
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's medical regulator, said: "Implanted devices don't need to be removed."
The move comes amid growing concern about the safety of vaginal mesh implants, which are made out of polypropylene plastic.
The National Institute for Health and Care Excellence (NICE) recommended in December 2017 that vaginal prolapse mesh surgery be banned.
Mesh implants used to treat incontinence were suspended pending a UK-wide safety review led by Baroness Julia Cumberlege in July 2018.
Vaginal mesh is also the subject of mass litigation worldwide.
Sky News has reported extensively on the devastating consequences of mesh implants to women, including chronic pain, inability to work and have intimate relationships.
Bard's decision to withdraw its product has been welcomed by campaigners including the Sling The Mesh group which has more than 7,000 members.
Kath Sansom, the group's founder, said: "Sling The Mesh is delighted that hospitals across Great Britain must clear its shelves of Bard urogynaecological mesh products.
"This is huge news for campaigners and means until further notice no women's pelvic mesh operations are allowed in this country.
"It is also tinged with sadness because this operation has destroyed hundreds of women's lives.
"Every day we see women struggling to cope with excruciating pain, some suicidal, seven out of 10 have lost their sex lives and many report failing marriages.
"For those with children at home it affects them terribly, some children end up having to be carers.
"It is disappointing that the government do not think women with Bard mesh implanted need to be recalled or have this product removed."
An MHRA spokesperson said: "We are aware C.R. Bard have decided to stop selling all vaginal (urogynaecological) mesh for stress urinary incontinence and pelvic organ prolapse and intend to withdraw remaining supply worldwide.
"It's important to note, there are no specific safety concerns associated with this recall and there is no need for people to have the device removed or have any extra follow-up checks."
Owen Smith MP, chair of the all-party parliamentary group into surgical mesh, told Sky News: "The hasty withdrawal of this mesh device is yet another indication that the majority of doctors and patients all over the world have now lost all faith in mesh.
"NICE needs to catch up with this trend and understand that their new guidelines, when they are published shortly, should be clear that mesh is to be used only in the very last resort, after physiotherapy and other surgical options have been ruled out."
NICE is due to publish its updated guidelines on vaginal mesh next month.
https://news.sky.com/story/major-surgical-mesh-manufacturer-bard-to-pull-vaginal-implant-products-11657919
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BD’s Bard pulls all pelvic mesh products from EU market
Mar 7, 2019 | Mass Device
By Fink Densford
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard is removing its women’s pelvic organ prolapse and stress urinary incontinence mesh devices from the European Market, according to a recently posted field corrective action from the company.
The Murray Hill, N.J.-based company said that it is “initiating a cease in production and distribution of these devices and a removal of these products from hospitals and distribution centers with immediate effect,” according to the notice.
The removal of the devices was not a result of safety concerns, Bard clarified, adding that patients with such devices do not require any follow-up activities.
In the letter, Bard instructed individuals with affected devices to locate and quarantine them and to notify anyone who the products have been distributed to so that the devices could be appropriately returned.
The company again reiterated that implanted devices are not affected by the recall, and that no additional activities are required for patients with the meshes.
In January, Bard and subsidiary Davol won an appeal in a lawsuit involving a woman who died a year after having a Bard surgical mesh patch implanted to repair a hernia.
https://www.massdevice.com/bds-bard-pulls-all-pelvic-mesh-products-from-eu-market/
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BD withdraws surgical mesh products for SUI and POP
Mar 7, 2019 | Medical Plastics News
Becton, Dickson and Company has withdrawn its surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) – manufactured by C R Bard – from hospitals and distribution centres, with the company saying the move is part of its business strategy.
A spokesperson said: “BD has decided to discontinue the manufacture and sale of pelvic organ prolapse and stress urinary incontinence products in all remaining markets worldwide. While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements.”
The government website says there is no need for implanted devices to be removed and no additional follow-up is required for patients implanted with such devices but anyone who has any concerns about their implanted device should contact their GP.
A Medical Device Alert statement read: “We are aware C.R. Bard have decided to stop selling all vaginal (urogynaecological) mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) and intend to withdraw remaining supply worldwide.
“It’s important to note, there are no specific safety concerns associated with this recall and there is no need for people to have the device removed or have any extra follow-up checks.”
Following safety concerns that have previously been aired, campaign group Sling the Mesh welcomed the withdrawal.
The group said: “This is huge news being celebrated by campaigners, but it is also tinged with sadness, because this operation has destroyed hundreds of lives.
“It is disappointing that the Government do not think women with Bard mesh implanted need to be recalled or have this product removed.”
https://www.medicalplasticsnews.com/news/bd-withdraws-surgical-mesh-for-sui-and-pop/
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Daughter of woman who suicided after mesh surgery wins legal battle against surgeon
Mar 8, 2019 | Newcastle Herald
By Joanne McCarthy
Pelvic mesh surgeon Richard Reid dealt a final blow to the daughter of a woman who took her life in 2015 following mesh surgery, after he tried to stop being "named and shamed" as her doctor.
The former University of Newcastle associate professor lost the fight in February.
Leesa Tolhurst, who sobbed as she talked about her mother Alison Blake's desperate final weeks, and the devastation she felt after Dr Reid, 79, tried to stop her naming him as Ms Blake's surgeon, has called for a full inquiry into the pelvic mesh scandal, with power to subpoena documents and compel evidence, after serious unanswered questions following a 2018 Senate inquiry.
The call comes a day after peak national consumer health groups announced an April forum in Melbourne to make major health reforms - including an overhaul of medical device approval processes after little action despite years of device scandals - a federal election issue.
"No-one responsible for this has really been held accountable and women like my mother have just been abandoned. She went in for surgery trusting the doctor, the hospital and the health system and she was failed at every point," Mrs Tolhurst said.
"My mother wanted her ashes to be scattered across the ocean but I'm not ready to let her go. I want to know how this happened. I want to know who is responsible and I don't want any other woman to feel as abandoned as my mother did that she would take her own life."
Ms Blake was implanted with the Australian-developed Tissue Fixation System (TFS) device in February, 2014, whose prototype was exclusively distributed by the Australian Medical Association as a "design breakthrough".
Although it was cleared for use in women's bodies in 2006, it was not until December, 2018 that a tribunal confirmed its South Australian manufacturer, TFS Manufacturing, headed by former champion Australian basketballer Paul Zadow, could not provide evidence substantiating its safety, quality and performance.
The device was put on the market from 2006 under what the Administrative Appeals Tribunal described as Australia's partial "self-regulation" device assessment system.
Ms Blake was not aware, and had little or no way of knowing, that she was implanted with the TFS device at Sydney Private Hospital only months after Dr Reid was suspended, after another patient required an urgent public hospital transfer following surgery by him.
Ms Blake and other pelvic mesh patients also had "no inkling" they were implanted with the TFS device after the hospital's medical advisory committee imposed a condition requiring Dr Reid to "adopt… the Tissue Fixation System (TFS) for his pelvic floor surgical cases" after his suspension was lifted, a NSW disciplinary tribunal in 2018 found.
The medical advisory committee also imposed a condition that TFS inventor Professor Peter Petros supervise Reid during surgery to implant the device.
Ms Blake was unaware, and had little or no way of knowing, of Dr Reid's long and troubled surgical history, which included a suspension in America in the 1990s after multiple complaints from women patients leading to legal settlements, and serious complaints in Australia leading to conditions over his practice.
In September the NSW Civil and Administrative Tribunal found Dr Reid guilty of professional misconduct after complaints by 17 women who suffered serious injuries after surgery by Dr Reid for incontinence and prolapse complications linked to childbirth. The tribunal's penalty of five years' deregistration could not be enforced because he retired before the decision.
No-one responsible for this has really been held accountable and women like my mother have just been abandoned. She went in for surgery trusting the doctor, the hospital and the health system and she was failed at every point.Leesa Tolhurst, whose mother Alison Blake suicided after mesh surgery.
Mrs Tolhurst wept at doctors' evidence to the NCAT hearing describing her mother as one of the "salvage cases", where a doctor attempts to "salvage" an outcome because of previous failed pelvic mesh surgery.
Ms Blake was one of two women sent home after surgery by Dr Reid to self-catheterise on a permanent basis because they were unable to urinate following mesh surgery. He was strongly criticised by NCAT for carrying out three mesh surgeries on Ms Blake over two weeks, failing to produce written informed consent for two of the surgeries and breaching a condition on his registration requiring him to obtain a second opinion for some surgery.
Ms Blake, 64, took her own life in June, 2015, 16 months after the surgery, and only two weeks after a doctor told her nothing could be done to ease her pain or address the devastating consequences of her mesh surgery.
"I cannot bear the thought of leaving you but the emotional torment and physical pain I'm going through are just too much," Mrs Blake said in a final letter to Mrs Tolhurst, her only child.
"I simply cannot bear to be lying on a couch for months on end and to have to rely on catheters, enemas, Temazepam, pain killers and be a burden to my family and friends."
Mrs Tolhurst said she applied to NCAT to have a non-publication order over her mother's name lifted after the September ruling against Dr Reid, to give her mother the dignity she was denied in the final period of her life.
"I want her story and her name to be together so that she's known as a person rather than Patient O. Her name is Alison Blake. She lived her life and she had a good and full life until this happened," Mrs Tolhurst said.
She was devastated when Dr Reid challenged the lifting of the order that prevented Mrs Tolhurst from naming her mother as one of his patients. In a submission to the tribunal Dr Reid criticised previous Newcastle Heraldcoverage of his surgical history, and said the application was to facilitate "naming and shaming" him.
I want her story and her name to be together so that she's known as a person rather than Patient O. Her name is Alison Blake. Leesa Tolhurst
"If the non-publication order is lifted, the media story to follow is likely to be hurtful and unfair, with little opportunity for Dr Reid to defend himself before damage is done," his lawyer said in a submission.
The tribunal lifted the order on February 21 after finding articles would allow broader discussion of pelvic mesh issues.
Mrs Tolhurst said she would continue to grieve for her mother and was heartbroken that other women are suffering, after a Senate inquiry heard evidence from many women about feeling suicidal because of the pain of mesh complications.
"So much of this could have been stopped long ago if women had been listened to when they said things were very wrong. If the only thing I can do now is speak for my mother on behalf of other women, then that's what I'll do," she said.
On Wednesday a leading Australian consumer health group released the results of a hernia mesh survey that concluded a "perfect storm of systemic failures" had left an unknown number of pelvic and hernia mesh surgery patients with severe complications that confirmed the need for urgent health system reforms.
The Melbourne-based Health Issues Centre will hold a forum in April where pelvic and hernia mesh patients, the Therapeutic Goods Administration, health bureaucrats and politicians from around Australia will be brought together for the first time to discuss reforms to the health system, including the need for a health watchdog willing to prosecute to improve public safety.
National consumer health groups want health reforms to be a federal election issue.
In 2017 the TGA confirmed it had not pursued the prosecution of a single manufacturer for failing to report serious pelvic mesh injuries to women despite thousands of known serious injury cases linked to mesh, criminal sanctions if a manufacturer fails to report, and a 2013 TGA report acknowledging it “only receives 10-20 per cent” of all adverse events.
"Does Australia have a strong watchdog in the TGA? Clearly not," Health Issues Centre chief executive Danny Vadasz said.
The Consumer Health Forum of Australia has called for an inquiry into the responsibilities, operations and funding of the TGA, saying the current model of funding by industry rather than government was failing the public.
https://www.theherald.com.au/story/5931301/pelvic-mesh-doctor-fights-naming-and-shaming/
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What's on your mind? What women in Canberra are thinking about
Mar 8, 2019 | The Canberra Times
By Sally Pryor
International Women's Day means different things across the generations. Here, we ask five Canberra woman - and one schoolgirl - what's on their mind in 2019.
At school, I am worried about bullying, because I think it happens all over the world, in every school. Generally, I think cancer and climate change are important. Lots of people have died from cancer. Also animal abuse and stuff like that.
I worry about getting to school on time, because my home is very far away [in Belconnen]. I’ve started going on the bus with my dad and my brother, because I have dance, and I have to go on the bus because my parents can’t take me everywhere. Today we went for the first time. I’ll be fine. My brother is eight turning nine.
With dance, I’m in a troupe and I have to go because if I didn’t go twice, I’d probably be out. It’s a ballet lyrical contemporary and also a bit of acrobatics. I sometimes worry about my friends, if they don’t like me anymore, or if I did something wrong. I have at least four best friends, and the others are just friends-friends.
Dance gets me really excited with the competitions, and at school I get really excited because I’m working with my friends, and some of the activities that I really like to do, I really enjoy. I think I have more English homework than French homework, but I manage. I also do Spanish after school because my parents are from Argentina.
As a student my main attention is on school and university, family, friends, all those things, and how to manage them all. I think that’s what most kids my age are coping with, because there’s so many parts of life when you’re a uni student - extracurriculars and hobbies and mental health. All those things are important to manage.
In terms of the bigger picture, it depends on where you’re looking. In Australia, of course, there are issues like sexual harassment in the workplace, and we keep hearing things about the #MeToo movement, but I do think in 2018 we did see changes starting. I think we’ve transitioned from a phase of recognising that there are faults to actually making solid achievements. But again, International Women’s Day is around the globe, so there are definitely things in other countries that need to improve in terms of how women are treated, be that abuse or violence or anything.
I think we’ve transitioned from a phase of recognising that there are faults to actually making solid achievements.
Also, I think sometimes people perceive gender equality to be a race or a competition in Australia - "We’re ahead, so what’s there to complain about". But from a privileged place, I think we could also see how we could help countries and target aid towards women’s empowerment in other places, as well as improving Australia.
As a woman of colour, it’s really good to see in the media more faces that look like mine come to the forefront. If that could continue this year, that would be great.
Ashleigh Feltham, 29, dietitian and nutritionist, founder of Feed Your Future Dietetics
I’ve always been very active. I started off with group fitness and then did my masters in nutrition and dietetics, so my motto to life is to help women, especially, be more positive in their minds and also healthy in their bodies.
I think from a health perspective, what worries me is potentially disregarding the need to be healthy at both ends of the spectrum. Yes, we’re in an obesity epidemic, but on the other end of the spectrum, there’s a lot of push by numerous companies and even social media stars to be living in a way that’s not healthy either.
It’s the imbalance. There’s so much negative and incorrect information that that imbalance in health in a woman is almost unseen. It’s a big problem because information and the truth about how to be healthy to everyone is not known. People don’t understand that healthy at every size doesn’t mean accepting the obesity epidemic.
It’s a really fine line, because we need to be able to use our bodies not just to look good, but to feel good and to optimise what we can give to ourselves, but also to our families and to others. If we’re not healthy, I think that lesson has been lost.
I think women need to feel comfortable whatever they’re doing. It comes down to having confidence in yourself, but we do need to keep sticking up for each other as woman.
Maylee Thavat, 41, part-time public servant, micro-entrepreneur and founder of co-work space Good Work Canberra
I’m fascinated by the politicisation of the #MeToo movement and how there has been a complete swap between left and right on issues of trade and social liberalism.
The left is now pro-trade, with women arguing for the benefits of inclusion. When I was coming back into the workforce after having a baby, new opportunities in technology and trade in services allowed me to start a business, Good Work Canberra, but this was, and still is, a micro-enterprise that supplemented my income.
Much is made of start-up and innovation cultures, but while many women are starting up increasing numbers of businesses, few of them make it past micro-enterprises. In fact the vast majority of innovative and successful start-ups at scale are by men who have access and networks to finance, expertise and support. We need to peel back words like “innovation” to see what they really mean from a gendered lens.
I’m also surprised that the #MeToo movement hasn’t yet provided a groundswell of women’s action around healthcare issues, especially given high-profile cases concerning the Sydney gynaecologist, the Johnson and Johnson vaginal mesh case and more locally public letters from staff at the Canberra Hospital regarding the adequacy of maternal services. These issues are linked.
If we want more innovative, diverse and open economies, then the major issue that we know affects women’s careers and earning potential is ensuring that their reproductive capacity doesn’t end up disadvantaging them at the least, and certainly not traumatising them further.
Fiona du Toit, almost 50, architect and urban design manager of Transport Canberra Light Rail
This year, I'm thinking about the circle of life, the sense of home, history and intergenerational legacy.
I spend a lot of time thinking about time spent with friends and family, and our connection to place and landscape. I'm also worried about the health of the planet, of climate action and politics - part of Canberra's DNA!
As a born-and-bred Canberra, I'm thinking about safe places to play, social equity and sustainable housing opportunities.
Through my work as the urban design manager for Canberra's impending light rail, I'm thinking about strategic design and smarter sustainable decision making. From a larger perspective, through my work as a whole, I'm thinking about community investment and communicating value through great design; caring about public architecture, infrastructure and the everyday urban realm.
As a born-and-bred Canberra, I'm thinking about safe places to play, social equity and sustainable housing opportunities. As a mother, I'm thinking about adventures with my daughter, and the joy of learning new things. As a homebody, I'm thinking about what to plant in the veggie garden over winter and where we could fit in a fig tree. And finally, I'm thinking about the long view; where to best focus my energy, about having a voice and the best way to use it.
Claudia Hyles, 71, retiree, India enthusiast and refugee advocate
The plight of the refugees is certainly on my mind, not just the men on Manus and the people on Nauru, but refugees all around the world, and I belong to a refugee support team at my church, which is St Pauls in Manuka. We have fundraising events, three or four a year, and with another member I run an emergency linen cupboard, and we supply good household linen - blankets, doonas, sheets, towels - to several organisations in Canberra, especially Companion House.
I don’t feel my age, most of the time. We all suddenly think, 'Oh, I’m not as fit as I used to be', but I think I’m pretty fit.
I’m mad about my family, they’re always on my mind, my four grandchildren. And I really value my women friends. I think small circles of women friends are so valuable, at any age.
I don’t feel my age, most of the time.
As for the #MeToo movement, I was never bullied in the workplace. If anyone was ever tricky in the workplace it was usually a woman not a man. And several of my friends have had that situation. When all this stuff with harassment started, many of generation said well, we all had people groping and unpleasant things like that, but we just said, "Piss off".
I do understand that the workplace is much more competitive than it was 50 years ago, and women do have to keep their wits about them. I’m not inpatient with it, but I think it’s got a bit overblown.
https://www.canberratimes.com.au/national/act/what-s-on-your-mind-what-women-in-canberra-are-thinking-about-20190307-p512hh.html
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