Preview Newsletter
Ethicon Media Monitoring 2/14/2019
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Government accepts 'debilitating' effects of medical implants
Feb 13, 2019 | The Guardian
By Hannah Devlin
Patients have suffered “debilitating consequences” from medical implants that doctors had assured them would be safe, the government has said in a significant acknowledgement of failings in medical device regulation. -
The Road to FDA Approval for Pelvic Organ Mesh
Feb 13, 2019 | Mesh Medical Device News Desk
By Jane Akre
The panel agreed more information is needed of a long-term nature before outstanding questions are answered about the safety of mesh used for pelvic organ support. -
Public Hearing Highlights Dangers of Vaginal Mesh Devices
Feb 13, 2019 | Legal Scoops
By Jacob Maslow
After thousands of complaints and years of warning from the Food and Drug Administration (FDA), a public hearing was held to highlight the growing evidence of the dangers of mesh devices. -
Panel Recommends How FDA Should Assess Vaginal Mesh Data
Feb 13, 2019 | MedPage Today
By Kristen Monaco
Several safety and efficacy factors should be considered when evaluating transvaginal surgical mesh for treating pelvic organ prolapse (POP), an FDA advisory panel recommended. -
Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh
Feb 13, 2019 | Regulatory Focus
By Ana Mulero
A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews. -
ELLIS: Doctors, Lawyers with Monetary Motives Endanger Women
Feb 13, 2019 | The Washington Informer
By Greg Ellis
Women, especially women of color and poor women, tend to suffer disproportionately in our health care system. The problem is growing worse now that there’s a group of trial lawyers eager to exploit female victims, under the guise of offering help. -
Phila. Mass Tort Inventory Saw Record Decline in 2018, Court Reports
Feb 13, 2019 | Law.com
By Max Mitchell
Philadelphia’s Complex Litigation Center saw a record decline in the number of mass tort cases pending on its dockets over the past year, but overall the inventory remains high. -
Editorial by Dr. Greg Vigna, MD, JD
Feb 13, 2019 | Mesh Medical Device News Desk
By Jane Akre
Boston Scientific Corporation is marching down a dangerous course for women as it is complying with the FDA 522 orders related to transvaginal mesh (TVM) devices used for the treatment of pelvic organ prolapse (POP). -
Lawyer in mesh case loses bid to arbitrate malpractice lawsuit
Feb 14, 2019 | Reuters
By Tina Bellon
A federal appeals court has denied a Texas lawyer’s request to send a malpractice lawsuit against him into arbitration over claims that he misrepresented the final settlement payout in a hernia mesh case.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Government accepts 'debilitating' effects of medical implants
Feb 13, 2019 | The Guardian
By Hannah Devlin
Patients have suffered “debilitating consequences” from medical implants that doctors had assured them would be safe, the government has said in a significant acknowledgement of failings in medical device regulation.
The health and social care minister, Jackie Doyle-Price, said commercial interests had been prioritised over patient safety, and there had been other problems, including a lack of transparency and doctors’ failure to warn patients of the risks.
“It is fair to say that, perhaps in the past, regulation has focused excessively on what is in the commercial interests of businesses to maintain competition, rather than having patient safety at its heart,” Doyle-Price told a parliamentary debate on Tuesday evening. “It has not always been easy for patients to investigate and find more data about the things being put in their bodies.”
The debate, secured by Owen Smith, the Labour MP for Pontypridd, followed an investigation into the medical implants industry by the Guardian and other media organisations, coordinated by the International Consortium of Investigative Journalists (ICIJ). Smith said patients had been harmed by implants including vaginal mesh, metal-on-metal hips, breast implants and faulty pacemakers, because of serious underlying problems with the way such devices are approved for clinical use.
Doyle-Price said the government was looking at establishing a national medical devices registry that would make all implants traceable and alert regulators to problems once devices had been approved for clinical use.
“This matter is already under consideration … and it is linked to our wider digitisation agenda for the NHS,” she said. “We have the technology and we should use it in the interests of patient safety.”
Smith cited figures uncovered by the Guardian’s investigation, which revealed that UK regulators had received reports of 64,000 adverse events involving medical devices between 2015 and 2018, a third resulting in serious medical repercussions and 1,004 in death.
He said: “There are devices on the market here and across the world that are still causing grave medical problems for patients.”
Smith said problems included the failure to conduct clinical trials on a remarkable proportion of devices on the market, manufacturers being in charge of testing their own products after faults developed, and manufacturers being allowed to shop around for approval to market their products without having to declare any refusals.
The problematic relationship between doctors and companies was also highlighted. “Some [doctors’] have an interest in those companies, and others are getting a money benefit through doing this in the private sector,” he said.
Doyle-Price said of vaginal mesh, which can now only be used in highly restricted circumstances, that too many women had been given the surgery and she urged those who had had problems to pursue medical negligence claims against doctors.
Doyle-Price had previously said the benefits of vaginal mesh surgery outweighed the risks and had rejected calls for an inquiry.
Rules making it tougher for devices to get approval are due to be introduced in Europe in 2020. Doyle-Price said the government remained committed to adopting the same regulations, including in the case of a no-deal Brexit.
https://www.theguardian.com/society/2019/feb/13/government-accepts-debilitating-effects-of-medical-implants
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The Road to FDA Approval for Pelvic Organ Mesh
Feb 13, 2019 | Mesh Medical Device News Desk
By Jane Akre
The panel agreed more information is needed of a long-term nature before outstanding questions are answered about the safety of mesh used for pelvic organ support.
Meanwhile, three POP meshes remain on the market with manufacturers hoping to clear this regulatory hurdle with a “novel approach.”
Tuesday, the FDA gathered patients, doctors and a panel of experts in Gaithersburg, Maryland to determine the future of the three remaining polypropylene mesh implants still on the market used to treat pelvic organ prolapse (POP).
POP mesh supports pelvic organs – the uterus, colon or bladder – that can fall through the vagina due to gravity or childbirth. POP mesh is larger than “slings” that hammock the urethra as a treatment for incontinence and it is connected to some of the most devastating life-altering complications that have led to the filing of more than 104,000 product liability lawsuits in the U.S.
It generally cannot be removed.
Mesh complications include chronic infections, pain, mesh shrinkage, autoimmune reactions, nerve damage, and mesh erosion into organs, among other problems.
While the POP mesh placed next to the colon or posterior placement is off the market because of the complications, such as sepsis, the focus of this panel hearing was the three remaining POP meshes placed on the front of the vagina.
They include Boston Scientific’s Xenform (bovine dermis) and Uphold LITE, and Coloplast’s Restorelle DirectFix. Uphold and Restorelle are made of polypropylene and promise larger pores to minimize the buildup of infection and scar plate formation, a problem with the previous generation of pelvic meshes.
A NOVEL APPROACH
The challenge for Boston Scientific and Coloplast is how to have their meshes remain on the market with the least cost and effort.
Their PMA (premarket approval) applications are pending but they are attempting a never before tried approach to gain market share.
Back in 2012, the FDA required companies monitor the health of women implanted with mesh who were suffering complications. These 522 studies are a sort of an “after the fact” monitoring to make up for the lack of regulatory rigor imposed on manufacturers prior to selling the mesh. The 510(k) clearance process involves no clinical trials, just an exchange of paperwork.
Boston Scientific and Coloplast want to use the less rigorous 522 studies to keep their meshes on the market, something called a “novel approach” to approval by one panelist.
The FDA will not comment on when it will make a decision on the pending PMA applications but it generally follows the recommendations of any expert panel.
THE PATIENTS
The dozen or so patients and patient advocates testifying to the panel Tuesday morning were given five minutes each to testify during one hour. The rest of the day was taken up by the mesh industry, FDA representatives and panel discussion.
As many women report the emergency of autoimmune issues after their mesh implant, it was a setback to hear Dr. Geoffrey Cundiff, the current president of AUGS and a uyrogynecologist from Canada, say those conditions will not be considered by the panel.
(Interestingly, Dr. Cundiff stated he had no conflicts of interest even though AUGS derives approximately half of its support from the medical device industry, according to its annual reports.)
Leadership has been known to be well-compensated by the mesh industry. See Corporate membership here, the 2016 Annual report here, the 2017 Annual report here.
Autoimmune issues including fibromyalgia, Lupus, rashes, and systemic reactions have been noted in a substantial number of women who have undergone a polypropylene mesh implant.
How many? No one knows because it is not being tracked.
So in discussing the safety and efficacy profile of the post approval monitoring, no autoimmune reactions were considered. Any patients with connective tissue disorders, or pre-existing autoimmune issues were eliminated from the 522 studies.
THE TESTIMONY
Among those testifying in opposition to the easier standard for mesh approval were lawyers, statisticians, patients and health advocates.
Kila Baldwin, of Kline Specter, a Philadelphia law firm that has won hundreds of millions of dollar for mesh-injured clients, said her firm has 3,000 current clients who have had mesh placed for anterior prolapse repair.
“The vagina unlike like the abdomen where hernia mesh had been used has unique bacteria and peroxides that cause scarring and inflammation. The mesh stiffens causes retraction, loss of pelvic elasticity, organ dysfunction, erosions, and or pain.
“Unlike complicates associated with the native tissue repairs, mesh complication are permanent. You can’t undo you do you retraction and scarring. The complications of transvaginal mesh used in the compartment far outweigh the stated benefit of less chance of recurrence.
“These complications have been well-known among mesh manufacturers, and the physicians who consult with those manufacturers for many years.”
She added that no mesh should be marketed until adequate long-term studies are conducted.
Patient Barbara Melling, who traveled from Oregon to the meeting, said her life has been destroyed by pelvic mesh and she recounted how at one time she had to void (urinate) using a bucket in her living room.
“Nobody is listening to us!” she said visibly upset.
Michael Carome with Public Citizen filed a petition in 2011 to have nonabsorbable surgical mesh for POP pulled from the market. Three years later, in 2014, the FDA denied the petition, despite the fact that in 2011 the agency determined mesh injures from POP mesh are “not rare.”
The FDA allowed POP mesh to remain on the market even after it had been reclassified as high risk or class III, he said.
He called the 522 studies inadequate, because they were non-randomized and unblinded.
“These studies revealed the use of these products did not result in better subjective success rates than native tissue repair at one, two, or three years. In terms of risk, on the other hand, a review of the literature demonstrates the use of mesh leads to high rates of serious complications, many of which require additional surgical intervention and some of which are not amenable to surgical correction and result in harm.”
Madris Tomes, formerly with the FDA, has now formed her own company using FDA data called Device Events. While the FDA’s MAUDE database of injuries can show 500 events at a time, in a few seconds she found 139,000 reports of mesh complications with 1,107 deaths.
Specifically for POP mesh there have been 64,000 injury reports and 393 deaths associated specifically with POP mesh. She added that for every 100 adverse event reports, the OIG estimates that 66 reports are submitted and are not publicly available to view.
“Typically reports to the FDA only 17% of them are from physicians. And that’s globally across all devices. With this type of mesh, that number increased to 26%. There are over 17,000 physician reports about this device. I’m not sure how many of you are physicians, but most physicians don’t have a lot of time to do adversity event reporting, and they’re not mandated to do so. When I see this number of adverse events, I have to think that the issues are fairly serious.”
Dr. Diana Zuckerman of the National Center for Health Research testified that mesh changes overtime and has resulted in “nightmare” outcomes for some women. “We don’t know how many women and are uncertain just how often it happens and how long it takes.” Registries are not the answer because they focus on reoperations and many complications are not related to a repeat surgery.
“I don’t usually like to use the term “nightmare” what I’m talking to a professional group, but I don’t think you could describe the problems that some of these women have been having in any other term. These are really terrible outcomes for some women.
“So really, the only uncertainty is how often it happens and how much years it takes. I mentioned on this nightmare scenario five to 10 surges but you’ve heard today that it can be many, many more than 10.
“And that’s the reason — and you’ve also heard that sometimes these symptoms appear after five years.
“So these one-year studies are just inadequate, and even a three-year study is inadequate. You need a longer-term study to really know what’s going on.”
A 522 study is not the same as a clinical trial testified Cindy Pearson, Executive Director of the National Women’s Health Network.
While the PMA conducts randomized, large long-term blinded assessments, postmarket surveillance does not meet that standard she said.
“Products used chronically, in people who do not have a life-threatening condition are typically randomized, large, long-term v blinded assessment, and very scrupulous follow-up to insure a low loss to follow-up rate. Postmarket surveillance studies don’t meet those standards in general, nor do they in this case.
“While it may be fair to companies, it’s not fair to women. PMA standards are what women deserve.”
INDUSTRY AND FDA DEBATE
In the afternoon, mesh manufacturer Boston Scientific’s Dr. Ronald Morton Jr. MD testified. Initially he turned to face the audience behind him to apologize to those injured by mesh but quickly realized he was off microphone.
Miles Murphy MD, and a Boston Scientific consultant, said he had been compensated for his time but has no investment in the company. Surgical technique for transvaginal mesh has improved over time he opined and now mesh erosion is down from 11-18% to 0-8% for the Uphold with no official erosions reported.
“While it might not be for all, the availability of TVM is critical for optimizing the treatment for all patients.”
A statistician, Jason T. Conner Ph.D questioned the skill set of physicians implanting mesh, which has been shown to vary. Some doctors were trained on implanting transvaginal mesh during weekend cadaver clinics.
What constitutes a “volume surgeon” was debated? Do three surgeries a year amount to a volume? Hopefully not, said chairman Dr. Keith Isaacson who opined he hoped his pilot had more than three flights under his belt when he flew home.
Ben Fisher of the FDA said that is not the agency’s definition. Dan Morgan MD suggested 12 surgeries a year or more would be considered a higher or adequate volume surgeon.
Most panelists discussed the difficulty of keeping women in a 522 study for the long-term beyond one year, yet that is essential to understand complications and should be extended to at least three years.
What is the reasonable length of time for a mesh medical device? About ten years said panelists, however, pelvic mesh is a permanent medical device.
Industry assured the panel that the new meshes are improved with greater pore size over 1mm of traditional meshes, which causes less shrinkage and scar formation.
Richard Chappell
I hope that’s true, said Richard Chappell, Ph.D, a statistician.
Richard Chappell, Ph.D. – ” I owe it to patients who gave me such heart rendering testimony during 2011 not to be here in another 8 years well 2019 is old fashion methods and devices, now we have much better. “
The panelists had eight questions to answer including whether subject and objective considerations should be considered, (ie how she feels, her quality of live versus whether her uterus is in the right place) what symptoms should be measured, what level of training surgeons should have, and what is the expected durability of a mesh repair versus a native tissue repair?
Most testified during the Q and A that there is not yet enough information yet to answer these questions.
Currently there are five PMA studies for POP mesh underway which are not available to the public until they are approved.
At least four manufacturers, J&J, Bard, Boston Scientific and Coloplast, still sell transvaginal mesh used to treat incontinence.
AUGS refers to it as the “Gold Standard.”
https://www.meshmedicaldevicenewsdesk.com/the-road-to-fda-approval-for-pelvic-organ-mesh/
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Public Hearing Highlights Dangers of Vaginal Mesh Devices
Feb 13, 2019 | Legal Scoops
By Jacob Maslow
After thousands of complaints and years of warning from the Food and Drug Administration (FDA), a public hearing was held to highlight the growing evidence of the dangers of mesh devices.
Women from across the United States gathered at the hearing to share their stories about how mesh products have changed their lives.
One woman, Jodie Callahan, had surgery in 2010 at 45 years of age. She said she was one of more than 100,000 women who had been severely and permanently harmed by transvaginal mesh devices. Callahan said she saw nine different specialists to help her deal with the problem. The severe pain limited her activities with her family.
Three years later, a surgeon removed the mesh.
In Callahan’s case, the mesh had eroded into her bowels, bladder, nerves and muscles. The incontinence sling twisted her urethra, so it became nearly impossible to empty her bladder. A large gelatinous cyst was also removed from her cervix, which was engulfed in mesh.
She’ll have to undergo another surgery after her doctor found more plastic mesh in her body.
The FDA warned of the serious complications of mesh implants in 2008. In 2011, the agency mandatedthat companies produce studies showing the device is safe for use.
Complications associated with vaginal mesh products are wide-ranging, and include: pelvic pain, obstruction, erosion of mesh, incontinence, pain during sexual intercourse, and pain in the groin, leg and hip.
In some cases, the plastic hardens and erodes into the vagina. Sexual partners have been scratched during intercourse, and OBGYNs have had their gloves cut during the exam because of the mesh eroding through.
Some doctors still stand behind the product, claiming that it helps women who need to repair weakened pelvic tissue, prolapse and urinary incontinence.
Vaginal mesh products have been banned in Australian, Scotland, Ireland and the U.K.
https://www.legalscoops.com/public-hearing-highlights-dangers-of-vaginal-mesh-devices/
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Panel Recommends How FDA Should Assess Vaginal Mesh Data
Feb 13, 2019 | MedPage Today
By Kristen Monaco
Several safety and efficacy factors should be considered when evaluating transvaginal surgical mesh for treating pelvic organ prolapse (POP), an FDA advisory panel recommended.
The Obstetrics and Gynecology Devices Panel, which convened here Tuesday, made specific recommendations to the FDA for evaluating postmarketing data on the three surgical mesh devices that remain on the market today -- Boston Scientific's Uphold LITE and Xenform and Coloplast's Restorelle DirectFix Anterior.
For years, safety concerns have dogged anterior-placed mesh in the vaginal compartment, which were reclassified as high-risk class III devices in January 2016. Thousands of adverse events and serious injuries, including several deaths, have been reported to the FDA in relation to the devices. Now the agency is considering what to do with data from ongoing postmarket surveillance studies of these remaining devices, and sought the committee's advice.
Evaluating Efficacy
Following a full day of manufacturer presentations, patient testimonials, and statements from professional societies -- including the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, and the Society of Gynecologic Surgeons -- the panel deliberated for several hours. Of top concern included how to evaluate safety and efficacy, particularly when comparing these therapy options to native tissue repair, another method of POP treatment.
Most panel members said studies comparing the two types of repair must show superior efficacy of the surgical mesh in order to justify its higher risks, and superiority should be demonstrated at 12 months, 24 months, and 36 months post-op.
"I do think that it needs to have superiority because there are very specific complications associated with mesh, so I don't know what the purpose would be of finding an equivalently bad process that might also have higher levels of complications," commented panel member Donna Mazloomdoost, MD, of the National Institutes of Child Health and Human Development in Bethesda, Maryland, who added that superior efficacy lasting only 12 months is "not sufficient because the whole purpose of using the mesh is durability, and to me 12 months is not durability."
Two panel members voted against requiring superiority, saying non-inferiority was sufficient.
"If we're looking at a group that already maybe has fewer options or because they've had more prolapse surgery or they've had other medical problems... maybe the non-inferiority is a reasonable standard because you're already treating a patient population that has fewer options and at least they're doing as well, or if not a little bit better," said Daniel Morgan, MD, of the University of Michigan in Ann Arbor.
Objective Versus Subjective Efficacy
Looking even closer at surgical outcomes, the panel discussed whether anatomic or objective outcomes, as well as subjective patient-reported outcomes should both be incorporated when assessing efficacy of surgical mesh compared with native tissue repair. The panel was in agreement that both outcomes must be considered when determining efficacy, but more weight should be given to subjective outcomes.
"If you had a score of 100, then 75% of that score should be subjective and 25% objective. So they should be looked at together but not weighted the same," commented panel chair Keith Isaacson, MD, of Newton-Wellesley Hospital in Massachusetts.
The panel went on to recommend that a validated questionnaire be used to blindly obtain this data both before -- in order to have baseline comparison data -- and after surgery.
Safety Concerns
When the committee turned to device safety, members discussed the FDA's previously compiled list of known adverse events that should be tracked, which included:Pelvic painErosion/exposure of meshDyspareuniaDe novo voiding dysfunction (i.e. incontinence)InfectionVaginal shorteningAtypical vaginal dischargeNeuromuscular problemsVaginal scarringDe novo vaginal bleedingFistula formation
Members said this was a "comprehensive list" but suggested adding intraoperative complications, such as hemorrhage. However, the panel agreed that pain was generally the most important adverse event to consider, particularly in regard to its impact on quality of life. The panel also recommended these adverse events be evaluated for at least 36 months post-operatively.
One question to the patient that the group recommended be included in a long-term follow-up study was: "Would you do this procedure again?"
"[This question] could be incredibly valuable as a tool to assess quality of life," suggested Isaacson.
Other Study Considerations
While discussing other research questions to consider beyond safety and efficacy, the panel touched on several potentially confounding variables for the FDA to bear in mind when evaluating the post-market data. One of these included the hot topic of the surgeon's level of training, which all panel members strongly felt could affect safety and efficacy outcomes for mesh versus native tissue repair. As a result, the groups recommended that studies gather data on the performing physician's volume of surgery cases and level of training.
Characteristics of the patient population should also be collected, members said, including comorbidities such as obesity or connective tissue disease that can influence outcomes. Baseline characteristics of the two surgery groups should be as similar as possible to eliminate these as confounding factors.
The FDA is not required to follow advisory panels' recommendations but it usually does.
https://www.medpagetoday.com/obgyn/generalobgyn/77991
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Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh
Feb 13, 2019 | Regulatory Focus
By Ana Mulero
A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews.
The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marked the second time FDA held an advisory committee meeting to consider regulatory actions needed to address the issue. As the body of medical device reports (MDRs) associated with the implants continued to grow since the last meeting convened in 2011, the implants were reclassified into class III.
Efforts to address concerns around the products indicated for anterior repair of pelvic organ prolapse (POP) trans-vaginally face certain barriers, including a lack of long-term studies. There only two manufacturers currently marketing three such implants in the US. The FDA-cleared implants include Boston Scientific’s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair Matrix, as well as Coloplast’s Restorelle DirectFix. Both manufacturers gave presentations at the panel meeting.
Patients described to the panel members how their lives took a turn after being implanted as it relates to their health, sexual activity and mobility. This has been evidenced by not just the growing body of MDRs to FDA’s Center for Devices and Radiological Health (CDRH) but also the nearly 100,000 patient lawsuits that have been filed across the US, resulting in millions of dollars in court settlements.
There has yet to be an FDA-issued large-scale recall, but some manufacturers voluntarily recalled and discontinued manufacturing of their transvaginal mesh products in recent years. These include C.R. Bard’s Avaulta Plus transvaginal mesh and the GyneCare product line from Ethicon, a division of Johnson and Johnson, which continues to face the largest number of lawsuits.
“My focus is to get mesh off the market,” said Lana Keeton, president and founder of the Truth in Medicine Incorporated, at the panel meeting Tuesday. “I’ve been focused on this for over 12 years.” This is due to the “severe harm to so many hundreds of thousands of women” caused by the mesh products, she said. She pointed to “14 or 15” reoperations she underwent to remove a portion of her stomach as likely the reason she survived after being implanted. Keeton also characterized treatment with these mesh products as “barbaric” and “medieval.”
Another patient argued her sex life with her husband had been destroyed post-implantation. “I was active. I rock climbed, went boating, jet skiing, horseback riding, ballroom dancing,” said Barbara Melling. “Everything has been destroyed and it’s not just me. People I’ve gotten to know in our groups have died,” she added. Boston Scientific offered an apology to patients who voiced such testimonies.
“On behalf of Boston Scientific and myself as a physician, I want to express my deepest sympathy and my sincere empathy for those women who have been harmed by surgical mesh therapies,” said Ronald Morton, a medical doctor at Boston Scientific’s urology division, during the panel meeting Tuesday.
Still, the manufacturers defended their products during the panel, citing data derived from the 2012 FDA-mandated postmarket surveillance studies under the agency’s authority of section 522 of the FD&C Act. Boston Scientific “firmly believes that the totality of clinical evidence supports the positive benefit/risk profile of its Uphold LITE and Xenform transvaginal mesh devices to treat pelvic organ prolapse,” the manufacturer concluded.
Yet Coloplast also advised on factors that fall outside the scope of 510(k) assessments on safety and effectiveness and benefit-risk profiles. These include device use history, the associated surveillance data and appropriate surgeon education. The panel of outside experts reached consensus on using at least some of these factors for evaluating the surgical mesh implants on the market.
In preparation for the meeting, CDRH developed an executive summary on the relevant clinical and regulatory background of the currently marketed surgical mesh devices. This involved a search of the agency's MDR database from January 2008 through October 2018, which identified a total of 11,274 MDRs. These include “10,391 reports of serious injury, 806 reports of device malfunctions and 77 reports of death,” CDRH said.
A 2013 spike of 3,881 MDRs—attributed to regulatory actions—and the subsequent drop that is reportedly “suspected to be the result of many manufacturers electing to stop marketing their devices indicated for transvaginal repair of POP upon issuance of the 522 orders” is shown in the graphic below.
Following the 2011 panel meeting, FDA required of the manufacturers to submit premarket approval applications (PMA) for their mesh products as these had been originally cleared through the 510(k) process. Both manufacturers submitted PMAs before the July 2018 deadline and these are currently under review.
CDRH has yet to provide its position on the panel’s new recommendations. CDRH spokesperson Deborah Kotz told Focus the center does not comment on the meeting itself “as a general policy” but “will carefully consider all of the input provided” from the panel and public speakers during the meeting.
https://www.raps.org/news-and-articles/news-articles/2019/2/experts-call-on-cdrh-to-consider-adverse-event-rep
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ELLIS: Doctors, Lawyers with Monetary Motives Endanger Women
Feb 13, 2019 | The Washington Informer
By Greg Ellis
Women, especially women of color and poor women, tend to suffer disproportionately in our health care system. The problem is growing worse now that there’s a group of trial lawyers eager to exploit female victims, under the guise of offering help.
Take, for instance, that roughly one-quarter of U.S. women suffer from pelvic floor disorders, and according to The Washington Post, about 3-4 million of them have been treated with transvaginal mesh. The vast majority of these women receive repairs using transvaginal mesh without complications, but a significant minority experienced serious problems.
After the publicity surrounding this issue hit the fan, the lawyers pounced. It has come to light that a collaboration involving some law firms, doctors, and finance companies are pressuring women into unnecessary surgeries to remove the mesh. Giving new meaning to the term “insult to injury,” this phenomenon, according to The New York Times, is leading unsuspecting women to the operating table — even in cases when the removal could worsen the symptoms.
If that’s not enough, some unscrupulous hedge funds are financing companies connected with law firms specializing in suing manufacturers of the mesh. These law firms often use overseas telemarketing callers in countries such as India and the Philippines to contact women, known to have had the mesh surgery, with offers to join in lawsuits to sue the mesh manufacturers.
The New York Times highlighted a growing problem that tends to target women: the industry grown out of medical device settlements. For example, a court-ordered, charitable fund, the Common Benefit Trust, established out of the Dow Corning breast implant settlement fund, which also resulted from a faulty medical device. The Common Benefit Trust appears to have used some of this money to fund policy centers, advocacy groups, and a conference on litigation.
Pelvic organ prolapse, a medical issue sought to be treated by the transvaginal mesh, is one of the most common reasons for women to have surgery. It is ranked among the top three reasons that women have hysterectomies.
Then there are racial disparities. Compared with African-American women, Latina and White women had four to five times higher risk of symptomatic prolapse, thought to be in large part due to the lower rates of African-American women reporting the condition as a problem to doctors. Researchers see this pattern as part of a culture where African-American and/or poor women will not typically see the condition as a problem requiring them to consider surgery.
Issues such as the transvaginal mesh that has revealed disparate treatment of women are not new. All patients — but especially women patients and minority patients that have traditionally been marginalized — deserve better than to be exploited in some of their most vulnerable times.
Those vulnerable times include childbirth and other areas of maternal health.
Dr. Niva Lubin-Johnson, president of the National Medical Association, which represents more than 50,000 African-American physicians on issues of health disparities and justice, says, “There is a crisis for African-American women that is related to maternal mortality — and that’s across any economic level and educational level for African-American women. We are losing in that area.”
As for the transvaginal mesh, Lubin-Johnson says women must take extreme precaution when contacted by anyone about removals of that or any other device.
“No, you go talk to your own physician about that and not to someone who is doing a cold call because of some possibility of joining a lawsuit,” she said. “Talk to your own physician first, even if they were not the one who put the mesh in.”
Since The New York Times began shining a light on these bad behaviors, federal prosecutors from the Eastern District of New York have begun investigating the allegations of unnecessary and unneeded vaginal mesh removal surgeries. According to reports, doctors, lawyers, financiers and others who may have been involved in the sham have been subpoenaed.
So if you’re considering medical treatment, be an informed consumer. Be sure to have your health care provider explain all of your options, as well as their possible risks and benefits. Though if these risks are not avoided, by all means, beware of financial lures to have surgeries that you do not need and could leave you in a condition far worse than before.
https://washingtoninformer.com/ellis-doctors-lawyers-with-monetary-motives-endanger-women/
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Phila. Mass Tort Inventory Saw Record Decline in 2018, Court Reports
Feb 13, 2019 | Law.com
By Max Mitchell
Philadelphia’s Complex Litigation Center saw a record decline in the number of mass tort cases pending on its dockets over the past year, but overall the inventory remains high.
According to numbers recently released by the court, a total of 9,716 cases were pending in the 11 mass tort programs at the First Judicial District as of early January. That number is a 1,268 decline from the 10,984 cases that were on the mass tort dockets at the beginning of 2018.
The decline is the largest year-to-year drop the court has seen since 2010, which is as far back as available data. Although the court saw 1,594 new cases filed over 2018, it also disposed of 2,903 cases, which was likewise the highest number of mass tort cases that the court disposed of in a single year. But the drop was not enough to erase the staggering growth the court system saw over 2018.
Between 2017 and 2018, the court saw a 77 percent increase in its total inventory, or nearly 4,800 cases added to the dockets. That increase was due mostly to the exponential growth of the Risperdal mass tort, which jumped from 1,945 to 6,200 during that year.
The decline between 2018 and 2019 was due mostly to the Reglan litigation, which fell 95 percent—from 2,073 at the beginning of the year to 97. Reglan was the largest mass tort program in Philadelphia as recently as mid-2017. The litigation, which stemmed from claims that the drug caused an incurable neurological disorder called tardive dyskinesia, reached a global settlement in early 2017, but the cases remained on the docket for some months, and by late 2017, it still made up nearly 20 percent of the Complex Litigation Center’s total inventory.
Risperdal, which has grown to 67 percent of the Complex Litigation Center’s inventory, saw little growth over 2018—adding nearly 350 cases, or 6 percent, over the 6,200 that were pending at the beginning of the year. According to attorneys handling the litigation, the explosive growth the court saw over 2017 was due mostly to the parties scrapping a tolling agreement, which led thousands of plaintiffs to file suit in order to preserve their claims.
Along with Risperdal, litigation over the drug Xarelto and the vena cava filters were the only other mass tort programs to see any growth over the past year.
According to the numbers, the Xarelto program increased by slightly more than 350 cases, or 22 percent, over 2019, growing from 1,619 at the beginning of the year to 1,972 as of early January.
The vena cava filter program added 161 cases, which increased that program from 277 pending cases to 438 by the beginning of the year.
All other mass tort programs saw their numbers drop.
Almost the entire 85-case inventory of the firefighter hearing loss litigation was taken off the dockets. According to the court’s numbers, the inventory went from 85 cases to one.
In August, the Pennsylvania Superior Court struck a blow to the plaintiffs in that litigation when it agreed with a trial court judge, who had determined that it was not sufficient for the plaintiffs to rely on industry standards when it came to their proposed safer alternative design, and instead the plaintiffs should have called an expert to support their argument. That ruling came only months after the U.S. Court of Appeals for the Third Circuit dealt the plaintiffs another blow by agreeing with a district court that the plaintiffs’ attorneys had failed to investigate the claims before filing suit and therefore needed to cover the attorney fees and costs for bringing the lawsuits.
The pelvic mesh litigation saw a decline of 31 cases, shrinking from 119 in early 2018 to 88 pending as of January. The Yaz, Yasmin, Ocella litigation dropped from 19 cases to three, and the asbestos litigation also saw an 18-case dip, which brought the total number of pending asbestos cases to 571.
When it comes to who is filing cases in Philadelphia, the number of plaintiffs hailing from out of state who filed pharmaceutical cases in the past year dropped four percentage points, from 90 percent to 86 percent.
The number of out-of-state plaintiffs who brought asbestos cases in 2018, however, increased significantly, from 47 percent to 60 percent. That number, which represents 154 new cases being filed by an out-of-state plaintiff, is the highest percentage of asbestos plaintiffs hailing from out of state since at least 2010.
Philadelphia Judge Arnold New, who oversees the Complex Litigation Center, declined to be interviewed for the story.
https://www.law.com/thelegalintelligencer/2019/02/13/phila-mass-tort-inventory-saw-record-decline-in-2018-court-reports/
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Editorial by Dr. Greg Vigna, MD, JD
Feb 13, 2019 | Mesh Medical Device News Desk
By Jane Akre
Boston Scientific Corporation is marching down a dangerous course for women as it is complying with the FDA 522 orders related to transvaginal mesh (TVM) devices used for the treatment of pelvic organ prolapse (POP).
As per the FDA’s 522 orders, Boston Scientific is proceeding with the Premarket Approval (PMA) procedure that will allow for it to market its Uphold LITE (polypropylene) device for anterior and apical prolapse.
Boston Scientific will be protected from future product liability lawsuits if it complies with the FDA 522 orders unless the studies are fraudulent. Under federal preemption, if a product undergoes premarket approval by the FDA, it is immune from lawsuits. That’s because federal law, ie, the FDA, trumps state law. A state cannot bring an action against a federally-approved device.
Since most mesh has been approved under the 510 (k) clearance process, it did not enjoy that protection from lawsuits.
Dr. Greg Vigna, MD, JD, a practicing physician, and national pharmaceutical injury attorney is assisting Plaintiff Steering Committees in various national litigations including the IVC filter litigation, Hernia Mesh litigation, and Mirena Pseudotumor Tumor Litigation and has reviewed dozens of manufacturer sponsored studies and notes that these studies are ‘fraught with obvious flaws that are grounded by bias aimed at obtaining a specific result that is required to proceed on with FDA approval as opposed to testing a hypothesis by an unbiased study procedure.”
Dr. Vigna does agree with the final conclusion of the February 12, 2019 FDA Executive Summary (here) ‘Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse in the Anterior Vaginal Compartment’ in that the FDA affirms its prior decision that the risks versus benefit of transvaginal mesh (TVM) devices do not justify their use at this time because these are permanent devices and the benefit must be clear and superior to non-polypropylene mesh procedures used in the treatment of POP.
Dr. Vigna’s opinion, is the following:
“The FDA doesn’t have the tools, expertise, and manpower to identify the bias in the studies just as it doesn’t have the tools, expertise, and manpower to monitor the complaints reported through its Medical Device Reporting (MDR) mechanism. Review of the top 10 complaints that led to MDRs reported related to TVM polypropylene devices from January 2008 to October 2018 doesn’t capture their catastrophic consequences. In the Figure 6, provided in the FDA Executive Summary there isn’t specific enough details that capture the seriousness of these injuries. For example: ‘pain’ is not quantified as to it severity and effect on function, ‘injury’ is patently vague, and ‘neurological deficit/defect’ isn’t specific as to its origin, and ‘disability’ is helpful to some extent but isn’t clear if this relate to inability to provide for simple activities of daily living or if this relates to vocational loss”.
Figure 6 – MDRs per year from January 2008 to October 2018.
Table 1 depicts the top ten patient problems received from January 2008 to October 2018. Please note that codes of “Other (for use when an appropriate patient code cannot be identified)” (n= 1,794), and “No Code Available” (n= 561) did not provide any insight as to a device problem and were therefore omitted from the table identifying the top patient problems. This list is not all inclusive and more than one patient problem code is often found in a single MDR.
Table 1 – Top 10 patient problems for MDRs received from January 2008 to October 2018.
Dr. Vigna has concerns that “the Executive Summary’ doesn’t mention anywhere the specific diagnoses of pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome as these diagnoses represents the most catastrophic complications of the TVM polypropylene devices used for POP and SUI.
He states, “if the FDA Executive Study doesn’t mention these diagnoses, how will a study devised by Boston Scientific identify them for the PMA process.” He goes on, “How will women be compensated for their foreseeable injuries caused by the defective device because a device that has gone through the PMA procedure will protect a manufacturer from lawsuit unless the results of the studies were obtained by fraud.”
Dr. Vigna is a national pharmaceutical injury attorney, who represents new injuries in cases filed outside the Multidistrict Litigation (MDL) in multiple states, and women within the MDL with diagnoses or symptoms of pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome who are preparing for individual litigation outside the confines of the Matrix Settlements.
https://www.meshmedicaldevicenewsdesk.com/17409-2/
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Lawyer in mesh case loses bid to arbitrate malpractice lawsuit
Feb 14, 2019 | Reuters
By Tina Bellon
A federal appeals court has denied a Texas lawyer’s request to send a malpractice lawsuit against him into arbitration over claims that he misrepresented the final settlement payout in a hernia mesh case.
The 1st U.S. Circuit Court of Appeals unanimously on Monday upheld a lower court’s decision to deny arbitration, clearing the way for the malpractice case to go forward in Rhode Island federal court.
To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2N6mJbR
https://www.reuters.com/article/products-arbitration/lawyer-in-mesh-case-loses-bid-to-arbitrate-malpractice-lawsuit-idUSL1N20902L
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