Preview Newsletter
Ethicon Media Monitoring 2/12/2019
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'Action needed' over problems of mesh surgery
Feb 12, 2019 | BBC News
A young woman who has suffered health problems since having mesh surgery said "something needs to be done". -
Tuesday's a big day for drug pricing and FDA
Feb 11, 2019 | Politico
By Sarah Karlin-Smith and Sarah Owermohle
...An FDA advisory panel is convening to discuss whether transvaginal mesh — one of the products at the center of rising criticism over medical device oversight — has enough benefits to stay on the market for anterior pelvic organ prolapse. -
FDA Panel Takes on Transvaginal Mesh -- Again
Feb 11, 2019 | MedPage Today
By Kristen Monaco
Transvaginal surgical mesh for the treatment of pelvic organ prolapse (POP), and its checkered safety history, will once again come before an FDA advisory panel Tuesday. -
FDA Meets on POP Pelvic Mesh, Final Day to Submit Comments
Feb 11, 2019 | Mesh Medical Device News Desk
By Jane Akre
Today, February 11th, is the last day to submit comments to the Federal Register as the FDA convenes its Obstetrics and Gynecology Devices panel Tuesday to decide the future of transvaginal pelvic mesh used to treat pelvic organ prolapse (POP). -
Women should not have to defend decisions they make about their own bodies
Feb 11, 2019 | The Badger Herald
By Julia Brunson
...“Medical malpractice” immediately draws to mind overblown, oversaturated late-night commercials, detailing the horrific consequences of faulty vaginal mesh, hip replacements or exposure to asbestos. -
Texas Atty Can't Arbitrate Malpractice Suit, 1st Circ. Rules
Feb 11, 2019 | Law 360
By Dave Simpson
The First Circuit shot down a Texas attorney's attempts to force into arbitration a dispute with a couple accusing him of botching their case over alleged surgical mesh defects, finding Monday that he can’t “change horses in midstream” by arguing against the application of a law that he’d previously embraced.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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'Action needed' over problems of mesh surgery
Feb 12, 2019 | BBC News
A young woman who has suffered health problems since having mesh surgery said "something needs to be done".
Chloe Thurston from Wiltshire, who had a mesh implant operation aged 15 for an internal prolapse, told the BBC her life was still affected five years on.
Ms Thurston was warned of the risks involved when she underwent the surgery in 2013, but was still dismayed when it went wrong.
It is believed she may be the youngest UK patient to have had the procedure.
A year since a government review of mesh surgery was announced, the woman leading it told the BBC hundreds of women had come forward and she had heard some "horrendous" stories.'Couldn't really walk'
Ms Thurston said she expected the operation to be "a quick fix" of her prolapse, also known as a sagging bowel, but discovered it was "the complete opposite".
"I got an infection somewhere in my body," she said.
"When I went home, I was obviously in a lot of pain, so I couldn't really walk and then I started to have bleeding, discharge and all sorts."
A year later, even though the prolapse went away, she was still suffering problems.
Her doctor has more recently diagnosed her condition as a bowel dysfunction, and said it was exacerbated by the biological mesh procedure.
Ms Thurston said she was not offered any other less invasive treatment such as physical therapy prior to her surgery.
Five years after her operation, Ms Thurston may have to have the mesh removed.
"Something needs to be done, it's five years down the line now and this is my life at home that's getting affected," she said.
The BBC is not naming the hospital or surgeon involved in Ms Thurston's case, but they said they were sorry to hear she was unhappy and would welcome the chance to discuss her care.
Baroness Julia Cumberlege, who is leading the government review, said she had been shocked by some of the "horrendous" stories she had heard.
The review was announced in February 2018 by then health secretary Jeremy Hunt, after complaints from many patients about the use of surgical mesh implants used to treat pelvic organ prolapse and incontinence after childbirth.
Baroness Cumberlege said what struck her was how little research had been done in the past about the use of mesh.
"To introduce a new product and not to have done proper research is actually inexcusable," she said.
"Once a new product is used then we want to be absolutely certain that there is a proper follow up. We want to ensure there is a proper database so that we know which surgeon inserted which particular mesh and into whom.
Baroness Cumberlege said she believed the "most important thing" was to "stop these sort of things happening in the future".
"We want to ensure the patients who have suffered will have a chance to have their voices heard. We have been appalled by the way they have been dismissed in the past," she added.
https://www.bbc.com/news/uk-england-wiltshire-47159939
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Tuesday's a big day for drug pricing and FDA
Feb 11, 2019 | Politico
By Sarah Karlin-Smith and Sarah Owermohle
The first commercial disclosing a drug’s list price will appear on a television near you by the end of March. Meanwhile:
— Tuesday will be a jam-packed day for pharma and medtech. How packed? Two congressional hearings and an FDA advisory panel on a controversial medical device. We’ll help you prepare for the mania.
— Trump wants to eliminate HIV in the United States. Here’s how Obamacare could help him.
— One PBM appears to be gearing up for a world where list prices fall. See where they’re headed.
** A message from EMD Serono: Multiple sclerosis (MS) is up to three times more common in women. At EMD Serono, we’re committed to helping these women. See how we’re working to help women with MS. **
Happy Monday and welcome back to Prescription PULSE, where your scribe Sarah Karlin-Smith spent the weekend practicing her balloon art in preparation for her first semi-solo volunteer clown gig this week. Send balloon requests, news and tips to Sarah (skarlin-smith@politico.com or @SarahKarlin) and Sarah Owermohle (sowermohle@politico.com or @owermohle)DRIVING THE DAY
GET READY FOR A PHARMA-FILLED TUESDAY — It’s going to be a busy day for drug and FDA events — and for better or worse, most of the action will be happening at the same time. Here’s our survival guide:
W&M DRUG PRICING HEARING: In the morning, the Ways and Means Committee — following the lead of the House Oversight and the Senate Finance committees two weeks ago — will dive into rising prescription drug prices. Think of it as part of the undercard for the Feb. 26 main event, when seven drug company CEOs have agreed to testify before the Senate Finance Committee.
This week’s Ways and Means hearing will feature Mark Miller, executive vice president of health care at Arnold Ventures; Rachel Sachs, an associate professor of law at Washington University in St. Louis, and Alan Reuther, legislative consultant for UAW Retiree Medical Benefits Trust. The American Enterprise Institute's Joseph Antos will also take the stand, as will Odunola Ojewumi, a patient from Maryland.
If the first two hearings on drug pricing in this Congress are any indication, don’t expect Ways and Means to break much new ground — after all, it's not as if Congress hasn’t held dozens of hearings on the matter the past few years. At Senate Finance and House Oversight, Republicans and Democrats expressed the expected sharp divisions over what government should do, with Dems pushing direct federal negotiations with drugmakers and Republicans favoring free market approaches. Areas of agreement emerged on some issues like prodding pharmacy benefit managers to be more transparent and discouraging patent-gaming by brand-name drugmakers to keep cheaper generic competition off the market.
SURGICAL MESH UNDER AGENCY SPOTLIGHT – An FDA advisory panel is convening to discuss whether transvaginal mesh — one of the products at the center of rising criticism over medical device oversight — has enough benefits to stay on the market for anterior pelvic organ prolapse. The product was originally marketed to women to support weakened pelvic organs, but reports of serious health issues, including severe pain, scarring, bleeding and neuromuscular problems, began piling up. So did litigation: transvaginal mesh ranks as one of the biggest mass tort cases in U.S. history, and has forced manufacturers to pay out billions of dollars to thousands of women.
FDA isn’t required to follow its advisory committees’ guidance, but it generally does. The committee's expert panel will review a group of studies on mesh sold by Boston Scientific and Coloplast, the two manufacturers still selling it for pelvic prolapse, and both are expected to present at this week’s meeting. Each has submitted briefing documents arguing that their products are safe and effective.
What the FDA says: Surgical mesh in this placement is riskier than surgically repairing the tissue because the mesh could erode or become exposed, injuring and even debilitating pelvic organs. To outweigh those risks, mesh needs to be significantly more effective than tissue repair — but FDA’s report for Tuesday states only that it “may have some advantage,” and there isn’t enough long-term data to determine how much.
… This isn’t the first time these questions have been asked. FDA convened a panel in 2011 that concluded there wasn’t enough information to establish vaginal mesh’s benefit and risk — leading the agency to bump it up to a higher-risk device category. Some other countries including Australia and the U.K. have already pulled the products off the market.
HELP HEARING ON MANAGING PAIN IN THE OPIOID CRISIS: The Senate committee is calling four experts to discuss treating pain, developing new medicines and improving care for patients. Scheduled to testify are Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation; Halena Gazelka, a professor of anesthesiology and chair of Mayo Clinic’s opioid stewardship program; Andrew Coop, a professor at the University of Maryland School of Pharmacy, and Anuradha Rao-Patel, lead medical director for Blue Cross Blue Shield North Carolina.
… Expect witnesses to emphasize personalized approaches to pain management that use both medicine and non-drug treatments. That’s a key principle for the U.S. Pain Foundation — along with ensuring that current chronic pain patients don’t get pushed aside by the quest to crack down on opioid prescriptions. The more holistic treatment strategy also is a key point in a December draft report by an inter-agency task force on pain management that emphasized non-opioid therapies as a first option.
“On the theory that every action has an unintended consequence, we want to make sure that as we deal with the opioid crisis, we keep in mind those people that are hurting,” HELP Committee Chairman Lamar Alexander (R-Tenn.) said in a statement.
In other opioid news, a planned Tuesday House Oversight Committee hearing on the White House's new drug control strategy has been postponed so members can attend former Rep. John Dingell's funeral
FDA APPROPS HEARING CANCELED AS FUNDING DEADLINE NEARS: The House subcommittee overseeing FDA appropriations also postponed a Tuesday hearing with Commissioner Scott Gottlieb due to Dingell's funeral. But this is still a big week for FDA funding with the stopgap spending measure funding the agency due to expire Friday.
The read of the Hill is that neither party wants to shutter the government again, but talks stalled Sunday leaving questions about whether lawmakers will reach a compromise on a long-term spending deal to keep the government open that would address border security. Negotiators were hoping to reach a formal compromise today, which would give the House and Senate time to move it through and on for President Donald Trump's signature.
If the border wall drama is resolved: FDA should be set for an immediate $268 million spending boost under the House-Senate conference agreement. But if Congress gives up and falls back on another continuing resolution, agency funding would remain at fiscal 2018 levels.DRUG PRICING
OPTUM Rx GEARING UP FOR A NEW REBATE WORLD? — The PBM unit of UnitedHealthcare looks to be preparing for the drug industry to lower list prices. According to letters sent to multiple manufacturers and seen by Bernstein financial analysts, the PBM is asking pharma companies to give it at least seven quarters advance notice of coming reductions in list prices in Medicare Part D. Optum also wants to receive equivalent rebates — in absolute terms, not percentages — off those lower priced drugs, as compared to the prices before reductions.
Bernstein analyst Ronny Gal says Optum is likely trying to ensure it has enough lead time to modify insurance plans that benefit from rebates. But drugmakers aren’t happy with the requests. HHS has been putting pressure on pharmaceutical makers to lower list prices, including issuing a proposed major overhaul to the rebate system
OptumRx spokesman Matt Stearns told Prescription PULSE that the letters were sent in December before the new rebate rule was released. It said its goal in asking for advance notice of price changes is due to the lengthy Part D bid process and its desire to achieve "greater transparency and predictability in consumer premiums and out-of-pocket costs." Optum added that it already offers point-of-sale discounts for patients in many of its plans and that it passes the vast majority of rebates directly back to health plans in Medicare Part D.
KEEP AN EYE OUT FOR CMS’S CAR-T PLAN — The agency gave itself until Feb. 16 to make a proposed national coverage determination for CAR-T cell therapies, laying out how Medicare programs should cover and reimburse for the nearly half-million dollar cancer drugs that are touted as one-time treatments.
It’s virtually certain that CMS will propose coverage with evidence development, said John Leppard of Washington Analysis. If so, Medicare programs nationwide would have to cover CAR-T but the agency would also require ongoing studies and a national registry.
Possible conditions to coverage: An advisory committee last August recommended including patient-reported outcomes in coverage, a move manufacturers largely opposed. That could mean more clinical studies by those companies, Leppard said — which in turn could push back timelines.
Alternatively, CMS could outline possibilities for value-based purchasing contracts. The agency ventured this way before with Novartis — proposing that it would pay for Kymriah only if patients’ cancer responded within three months— but quietly killed the contract last summer after Democrats raised concerns that Novartis was getting preferential treatment.
J&J WILL BE FIRST TO INCLUDE PRICES IN COMMERCIALS —Johnson & Johnson will be the first drugmaker to post prices of its products in direct-to-consumer advertising, earning applause from HHS Secretary Alex Azar for getting on board with the agency’s impending rule as others look for a compromise.
Drug lobby PhRMA unveiled the industry’s voluntary plan to include some price information in October, just hours ahead of HHS’s proposal to mandate explicit pricing details, like monthly wholesale costs, in ads. Azar said at the time it was “no coincidence” that industry beat HHS to the punch, adding that PhRMA’s own solution — directing patients to websites for costs — would not be enough.
So J&J is doing both. The company will start with its blood thinner Xarelto, giving its list price (about $450 to $540) and potential out-of-pocket costs in television commercials this quarter along with a website for insurance details.
“We call on other manufacturers to follow their lead,” Azar said in a statement, adding that list price transparency is “complemented” by the administration’s recently proposed rebate rule (widely seen as a win for the pharmaceutical industry). Other manufacturers could follow suit, but those that have acted so far are going with the PhRMA plan — Eli Lilly released ads earlier this year directing consumers to a website.EYE ON FDA
FDA UPDATES ITS SHAME LIST — The agency last week updated its public list of brand-name drugmakers that refused to provide generic companies with the samples they need to submit an FDA application. It was the first update since the list — formally known as Reference Listed Drug (RLD) Access Inquiries — debuted last May. Many of the brands are citing the FDA safety program known as REMS as the reason for not providing samples. The agency often writes letters specifically advising brands that REMS is not a reason to deny samples.
The list contains more than 50 medications from a variety of companies, including Bayer, Gilead, GlaxoSmithKline, Celgene, Novartis, Pfizer, AstraZeneca, Teva, and Roche. FDA received 14 complaints from generic companies trying to access Actelion’s pulmonary artery hypertension drug Tracleer, making it the product with the most complaints. Close behind was Celgene's cancer drug Revlimid, with 13 complaints.
HOW TRUMP’S HIV PLAN COULD GET A BOOST FROM OBAMACARE — In a bit of irony, the president’s plan to largely eliminate new infections by 2030 could be significantly aided by the Affordable Care Act. Trump used last week’s State of the Union address to outline the plan, which would target 48 counties that have been designated transmission hot spots. The administration said it would put new funding behind the effort.
The Trump plan includes a goal of increasing use of pre-exposure prophylaxis, better known as PrEP, which involves taking Truvada — an antiretroviral originally approved to treat HIV — to prevent infection. Obamacare could soon make PrEP free for patients. In late 2018, the U.S. Preventive Services Task Force issued adraft recommendation that doctors offer PrEP to people who are at high risk of acquiring HIV, giving the recommendation its highest "A" rating. People at high risk, as defined by USPFT, include those with a sex partner living with HIV and people who inject drugs and share injection equipment. Under the ACA, private health plans must cover preventive services with no cost-sharing if they are given an “A” or “B” recommendation by USTPF. Plans would need to cover the treatment starting one year after USPTF makes its final determination.
Current PrEP uptake is low: The country clearly could do a better job getting patients who qualify to try the drug. Gilead's Truvada is FDA-approved to reduce the odds of HIV infection in adults at high risk. Gilead has reported about 202,000 U.S. patients using its drug for PrEP, according to financial analysts at Raymond James. That’s less than 20 percent of CDC’s estimated 1.1 million candidates for PrEP.THIS WEEK IN PHARMATuesday: FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee holds a meeting to discuss the safety and usage of surgical mesh when treating pelvic organ prolapse.
Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) give keynote addresses at MIT Center for Biomedical Innovation NEWDIGS Initiative conference on paying for cures.
House Ways and Means Committee holds a hearing on prescription drug prices.
Senate HELP Committee holds a hearing on managing pain amid the opioid crisis.
Wednesday: NIH’s National Advisory Council on Drug Abuse hearspresentations on addiction and behavioral issues.
The National Academy of Medicine hosts an evening webinar highlighting initiatives combating the opioid epidemic.PHARMA IN THE STATES
Washington state embraces ‘Netflix’ model — Following Louisiana’s lead, Washington is asking drug manufacturers to submit proposals for a “Netflix”-stylepayment system for hepatitis C drugs. The state would pay a negotiated amount and then the winning bidder would have access to Medicaid patients, state prison inmates and participants in the state employee health plan.QUICK HITS
DOJ seeks dismissal of price fixing lawsuits — The Justice Department moved to dismiss two False Claims Act lawsuits filed by Dr. John Borzilleri, a physician-turned securities analyst and former hedge fund manager, who alleged a complex conspiracy involving multiple major drug manufacturers paying pharmacy benefit managers excessive “service fees” to keep prices artificially high. According to Forbes, Borzilleri didn’t have special qualifications — he neither worked in the industry nor had insider information — to make these claims. But he shorted the pharmaceutical companies’ stock after filing the suits in 2014 and 2015, hoping their value would go down. The False Claims Act “is not intended to be used as a lever to further private financial dealings by a whistleblower,” DOJ said in its Dec. 21 motion to dismiss.
Rare pediatric PRV program developments — Drugs for rare pediatric disease are more likely to advance into Phase 2 trials when they are in FDA's pediatric priority review voucher program, according to a Health Affairs study published this month. That was just about the only positive finding: No parallel trend was seen for later stages of development, and six years after FDA implemented the program it has not been linked with an increase in the number or rate of new drugs beginning clinical testing, write Aaron Kesselheim and colleagues at Harvard Medical School. Congress in 2012 expanded the priority review program in an effort to stimulate development of badly needed treatments for rare pediatric diseases. But the authors concluded that “new policies may be needed to expand the pipeline” of these therapies.PHARMA MOVES
Leah Christl, director of FDA’s Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, will leave the agency Feb. 22 to join Amgen as executive director, global regulatory and R&D policy. Sarah Yim, currently in FDA’s Office of Generic Drugs, will be acting director.
Mitchell Mathis, longtime director of FDA’s Division of Psychiatry Products, moved to Allergan as Chief Medical Officer for central nervous system products.
Brian Burns, a longtime Johnson & Johnson lobbyist, to its team has joined Brownstein Hyatt, POLITICO Influence reports.
AdvaMed added Amanda Walsh as associate vice president for government affairs. Walsh previously was a senior manager of legislative affairs at America’s Essential Hospitals, and worked for Hill Republicans before that.DOCUMENT DRAWER
Pew Trusts released a fact sheet on “challenges and opportunities” for treating opioid addiction in rural communities.
PhRMA’s submission for the U.S. Trade Representative’s 2019 Special 301 Report on Friday strongly advises, as it has in the past, that the United States “address serious market access and intellectual property barriers in the 24 overseas markets” named. More for Pros here.
FDA launched a pilot project program under the Drug Supply Chain Security Act that initially will assist the agency and members of the pharmaceutical distribution supply chain in developing an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed nationwide.
FDA finalized a new policy encouraging development of new buprenorphine treatments for opioid abuse.
AAM sent a letter to the chairs and ranking members of the Senate HELP and House Energy and Commerce committees arguing against bills in both chambers, S. 344 (116) and H.R. 990 (116), aka the Hatch-Waxman Integrity Act of 2019, that would restrict patent challenges by generic and biosimilar drug developers.
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https://www.politico.com/newsletters/prescription-pulse/2019/02/11/tuesdays-a-big-day-for-drug-pricing-and-fda-507587
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FDA Panel Takes on Transvaginal Mesh -- Again
Feb 11, 2019 | MedPage Today
By Kristen Monaco
Transvaginal surgical mesh for the treatment of pelvic organ prolapse (POP), and its checkered safety history, will once again come before an FDA advisory panel Tuesday.
Although three devices indicated for anterior transvaginal POP repair are currently on the market today -- Boston Scientific Uphold LITE, Boston Scientific Xenform, and Coloplast Restorelle DirectFix Anterior -- the benefit/risk profile of surgical mesh has been questioned more than once since the first device's 510(k) clearance in 2002.
Since then, numerous adverse events with mesh were reported, and the FDA took multiple steps over the years to manage safety concerns. The FDA requested that the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee convene to weigh in on the benefit/risk profile specifically for anterior-placed mesh in the vaginal compartment for POP repair.
The panel is tasked with voting on whether they agree that the efficacy of this device should show superiority to native tissue repair given the known risks, and at what time superiority should be demonstrated.
However, in briefing documents for the Tuesday meeting, the FDA noted that it is asking the panel to assess transvaginal surgical mesh placed in the anterior vaginal compartment as a whole, but not evaluate the safety and efficacy of three devices already on the market.
"The FDA intends to use the recommendations from the Panel to complete its review of the [ongoing] postmarket surveillance study results for the Boston Scientific Uphold LITE, Boston Scientific Xenform, and Coloplast Restorelle DirectFix Anterior," according to the briefing.
The mesh is indicated for treatment of POP, which occurs when one of the female pelvic organs drop from their normal position, often due to older age or childbirth. The four types of surgical mesh materials are:Non-absorbable synthetic mesh made of polypropylene or polyesterAbsorbable synthetic mesh including poly(lactic-co-glycolic acid) or poly(caprolactone)Biologic mesh such as acellular collagen derived from bovine or porcine sourcesA composite of all three
Adverse events with mesh identified through postmarket surveillance included pelvic pain, erosion or exposure of the mesh , infection, injury, incontinence, scar tissue formation, bleeding, urinary tract infection (UTI), disability, and neurological deficit or dysfunction. The FDA issued a safety warningin July 2011 addressing these safety concerns, stating such serious complications were "not rare." The safety warning also updated their views on the mesh, and discussed the uncertainty of whether this type of mesh provides any greater efficacy versus traditional non-mesh vaginal repair.
The FDA convened an advisory panel in September 2011 to further evaluate safety and efficacy, which led to the reclassification of the mesh as a high-risk class III device from a low- to moderate-risk class II label. At the time, the panel stated that more data were still required on the safety and efficacy of the devices, and called for more postmarket surveillance studies, otherwise known as the 522 studies.
This included 131 postmarket study orders to 34 various manufacturers, and calling for a randomized controlled study or parallel cohort study to compare their mesh with native tissue repair. At the time, most manufacturers ceased marketing the devices, and ceased marketing of surgical mesh for transvaginal posterior POP repair, which has the highest risk indication.
The FDA reclassified transvaginal mesh products as class III devices in January 2016, and ordered the submission of a premarket approval application for such devices. Devices already on the market also had to obtain approval to remain on the market, which Boston Scientific and Coloplast have completed.
Along with the postmarket study orders, the FDA identified 11,274 adverse events from medical device reports from 2008 to 2018. These events included over 10,000 serious injuries, over 800 device malfunctions, as well as 77 deaths reported.
The FDA conducted a literature review that included randomized controlled trials and prospective cohort studies from 2008 through 2018. They looked at the three devices indicated for anterior placement currently on the market. However, the FDA noted that this review focused on primary repair of POP, as there is limited data on recurrent prolapse despite all three devices on the market today being used for both primary and secondary repair.
Based on this review, the FDA explained in the briefing documents that the "risk profile for mesh is less favorable compared to native tissue repair," reinforced by the safety findings from randomized controlled trials at 12, 24, and 26 months, which also favored native tissue repair.
The panel will provide input on the specific types of adverse events that should be used when assessing safety, as well as how those events should be evaluated. They will also recommend whether the safety profile of mesh should be "comparable" to native tissue repair and weigh in on when comparable safety should be apparent.
Other topics of discussion will be how to select appropriate patients to receive these devices, as well as required training for surgeons.
https://www.medpagetoday.com/obgyn/generalobgyn/77956
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FDA Meets on POP Pelvic Mesh, Final Day to Submit Comments
Feb 11, 2019 | Mesh Medical Device News Desk
By Jane Akre
Today, February 11th, is the last day to submit comments to the Federal Register as the FDA convenes its Obstetrics and Gynecology Devices panel Tuesday to decide the future of transvaginal pelvic mesh used to treat pelvic organ prolapse (POP).
Industry and the anti-mesh community will testify to an expert panel gathered Tuesday as two mesh manufacturers attempt to convince the panel to keep three POP meshes on the market.
They include Boston Scientific’s Uphold LITE and Xenform, and Coloplast’s Restorelle DirectFix Anterior mesh.
Image: Rectocele, FDA
POP mesh is larger than mesh used to treat incontinence and is placed through the vagina to support the colon, uterus or bladder from prolapsing through the pelvic floor.
Transvaginal mesh, (placed through the vagina), to support the urethra to treat incontinence will not be the subject of this advisory committee made up of medical doctors, industry and patient reps. It is a smaller mesh, also sold in kits and referred to as the Gold Standard treatment by at least one medical society.
The FDA does not have to follow the advice of its expert panel but usually does.
Three years ago, POP mesh was reclassified by the U.S. Food and Drug Administration (FDA) as “High Risk” or class III due to the high numbers of complications being reported to the agency.
In response, the FDA required 33 companies to conduct post approval monitoring studies and industry quietly removed from the market three of the worst offending POP meshes including Ethicon’s Prolift, Boston Scientific’s Pinnacle and Bard’s Avaulta pelvic mesh kits. In doing so, they were relieved of conducting any post approval monitoring.
59 COMMENTS – THE FEDERAL REGISTER
With more than 104,000 product liability lawsuits consolidated in federal court in West Virginia, as of today there are only 59 comments. They include Dr. Vincent Lucente, MD, a preceptor for Ethicon who in court testimony has admitted to being paid at least $2 million by the company.
The panel members are here. Here is a link to the Meeting Materials. Which includes the Agenda, and an Executive Report.
Note the proceedings will be called to order at 8 AM. At 8:30 AM the public will be invited to testify in 5 minute statements until approximately 10:00 AM. Then after lunch, manufacturers are given approximately one-half hour to present information on the particular meshes they would like to reintroduce into the marketplace.
After an afternoon break, the panel will deliberate at approximately 3 pm. Here are the questions the panel will consider. The meeting should adjourn at 6:15 PM.
BACKGROUND
Uphold Mesh, Boston Scientific
In September 2011, an FDA expert panel concluded mesh placed transvaginally to treat pelvic organ prolapse did not have a “well-established benefit/risk profile,”
“It is not clear that transvaginal POP repair with mesh is more effective than tradition non-mesh repair,” said the FDA on July 13, 2011.
After counting the growing numbers of complication reports, the FDA concluded POP mesh complications were “not rare.”
By 2016, the FDA moved to reclassify POP mesh from Class II or moderate risk, to Class III or high risk. Incontinence mesh remains a moderate risk Class II even though at least half of the defective product lawsuits are due to incontinence pelvic mesh, also known as slings.
The agency also gave industry 30 months before it had to submit safety studies or remove its mesh from the market. Earlier the FDA ordered 34 mesh makers to conduct post approval studies, called 522 studies to assess the health of women who had received a mesh medical device. Instead, most POP meshes were removed from the market, relieving the company of the 522 study requirement.
The 30 month time frame concluded in July 2018. See story here.
Four of the postmarket surveillance studies for five surgical meshes are currently ongoing.
TESTIFYING
Among those testifying are Madris Tomes of Device Events. Formerly an IT project manager in its adverse event reporting program, she created her own more user-friendly database after leaving the FDA. Today, she investigates under-reported or mis-reported entries to the complication databases of the FDA to look for patterns of injury or death.
Tomes will testify that through January of this year there have been more than 139,000 adverse events reports for mesh products with 1,107 patient dying. The rest of her report is embargoed until after her presentation. MND will report its contents then.
Mesh injured women have vowed to have their voices heard before the FDA panel, but some tell Mesh News Desk, they are too sick to travel or are unable to afford the trip.
POLYPROPYLENE MESH
Uphold LITE, pore size 2.8 mm
While polypropylene (PP) mesh works for some people, at least in the short run, one of the world’s experts in mesh removal, UCLA urologist, Dr. Shlomo Raz, has stated he stopped putting it in when he saw complications up to a decade later.
Mesh trials have proven that traditional polypropylene mesh had a small pore size of less than 1 mm which caused bridging fibrosis or a scar plate that would cause the mesh and surrounding tissue to shrink, causing pain. That with injuries during placement, chronic infections, nerve damage, mesh erosion have led to personal injury trials yielding millions in awards to injured plaintiffs.
Interestingly, the meshes that industry will try to keep marketing have a larger pore size.
Uphold LITE Boston Scientific – A light weight PP mesh with a pore size of 2.8 mm smaller mesh footprint is used for anterior and apical compartments with a trocar-free approach. Boston Scientific has upgraded its warning to physicians here.
Xenform by Boston Scientific is a bovine (cow) dermis xenograft used for POP repair.
Coloplast Restorelle DirectFix Anterior is called a “Smartmesh technology” in an “ultra-lightweight mesh.” It too is polypropylene.
https://www.meshmedicaldevicenewsdesk.com/fda-meets-on-pop-pelvic-mesh-final-day-to-submit-comments/
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Women should not have to defend decisions they make about their own bodies
Feb 11, 2019 | The Badger Herald
By Julia Brunson
Medical malpractice is no joke. The idea that world-renowned surgeons, doctors and nurses might make a mistake while providing medical care is shocking. But it is all too common — the reality is, even experts can make mistakes, intentionally or not, often with serious physical and mental consequences for the patient.
“Medical malpractice” immediately draws to mind overblown, oversaturated late-night commercials, detailing the horrific consequences of faulty vaginal mesh, hip replacements or exposure to asbestos. Online, social media is proliferated with bizarre cases of negligence, from amputating the wrong leg, to leaving surgical sponges inside a patient for years.
After writing an article on Dr. John Siebert last year, I was dismayed to see his name emerge yet again next to the words “misconduct” and “negligence.” About this time a year ago, Siebert faced fiery criticismregarding an inappropriate sexual relationship with a patient, which required him to have a chaperone with female patients. The Wisconsin medical board reached the decision that Siebert’s actions were “a minor or technical violation” which were “not seriously harmful to the public.”
First, do no harm. Disregarding the morally grey area of allowing Siebert to continue practicing in Wisconsin, several Facebook commenters let me know, in plain, if not condescending language, just how much good Siebert was doing despite his impropriety. A sexual relationship with a patient, they claimed, was not solely malicious, nor was it a valid reason to dismiss Siebert or notify future patients of his past misconduct.
But these actions don’t emerge in a vacuum. They are often not isolated. If there is anything I have taken away from the #MeToo movement, it is that misconduct is not a singular event. It is a pattern, spanning power structures, gender, and years of silence. Siebert is no exception, it seems. Here we are, yet again.
Feb. 1, a female patient filed a lawsuit against Siebert, alleging that he “failed to use the degree of care, skill and judgment that reasonable physicians would use in the care and treatment of a patient” when performing a tummy tuck and breast implant procedure. According to the complaint, Siebert disregarded the patient’s requests, and inserted implants larger than those requested, before making inappropriate comments and stroking the patient’s face and legs.
I was disheartened, but not shocked, to find the comment sections of articles covering the lawsuit full of disbelieving and misogynistic remarks. What did shock me, however, were the numerous commentsmocking the woman for receiving cosmetic surgery, with several stating the patient should be “happy” with the larger breasts. Others implied she made up the claim either because her own sexual advances were not returned, or because she wanted financial compensation after discovering the past allegations against Siebert.
As a woman, reading through these comments disgusted me on several different levels. It is one thing to doubt allegations, and avoid making a judgment until a thorough investigation has been completed. It is wholly another thing to dismiss accusations of misconduct and malpractice simply based on the type of surgery a patient receives.
Thousands of women receive breast augmentation or reduction surgeries every year. It is a choice they have made for themselves and their bodies. And yet, we still tie sexual impropriety and vanity inextricably to the women who receive such surgeries. We look down upon any woman who has the audacity to make a choice for her own body. God forbid.
The idea that a doctor can dismiss the request and consent of a patient, and disregard the autonomy of that person, is unthinkable. Imagine waking up from a surgery to remove a tooth, only to find that the surgeon pulled all of your molars, too, because it “looked better,” even though you’d agreed before the surgery that you only wanted the one tooth removed.
In the case with Seibert, a woman was overruled, allegedly, because of a man’s desire to change her body against her will. We should be outraged — not laughing. Certainly not pulling up photos of the patient, and judging “for ourselves” if she should “really be mad.”
A person’s autonomy is not worth less simply because they are receiving cosmetic surgery. A woman does not deserve, nor should have to bear sexual comments and inappropriate touches merely because she has breasts and is not ashamed of them.
Our society idolizes large breasts, while simultaneously shaming those who receive augmentation surgery. This mentality leads to the inexplicable perception that this case is entirely the patient’s fault — and not Siebert’s.
The idea that someone “should be happy” with surgery they did not agree to would be unacceptable in any other context. This case must not be an exception.
https://badgerherald.com/opinion/2019/02/11/women-should-not-have-to-defend-decisions-they-make-about-their-own-bodies/
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Texas Atty Can't Arbitrate Malpractice Suit, 1st Circ. Rules
Feb 11, 2019 | Law 360
By Dave Simpson
The First Circuit shot down a Texas attorney's attempts to force into arbitration a dispute with a couple accusing him of botching their case over alleged surgical mesh defects, finding Monday that he can’t “change horses in midstream” by arguing against the application of a law that he’d previously embraced.
In a unanimous decision, the panel sided with a Rhode Island district judge, who adopted a magistrate judge's recommendation that the court uphold an arbiter's ruling that Rickie Patton and Cathleen Marquardt could sue and that their former attorney Barry Johnson is collaterally estopped from relitigating whether they agreed to the retainer's arbitration clauses.
The panel noted that Johnson told the magistrate judge “unequivocally” that the issue should be determined under Rhode Island law, making his later argument to the panel that the case should hinge on Texas law “little more than an attempt to lock the barn door after the horses had galloped away.”
“A party cannot successfully urge a magistrate judge to apply a particular body of law and then, dissatisfied with the outcome that he invited, ask the district court to apply some other body of law,” the panel said.
If they held otherwise, the panel said, they would be sanctioning “the use of misdirection as a tool for subsequent appellate advocacy.”
The dispute stems from multidistrict litigation in Rhode Island federal court over an allegedly defective hernia repair product referred to as Kugel Mesh, made by C.R. Bard Inc. and its subsidiary Davol Inc. Patton and his wife claim that Johnson and his firm misled and lied to them to persuade them to take a reduced portion of the settlement, according to court filings.
In their initial complaint, Patton and Marquardt sued the Johnson Law Firm and Johnson for legal malpractice and other claims arising from their representation of the couple in settling a Kugel mesh hernia patch case.
In November 2012, a Rhode Island federal court judge granted a motion to strike an expert report central to Patton’s case, which badly affected the settlement, according to court records. Records note that “the subsequent management of the case was fraught with conflict."
In August, U.S. District Chief Judge William E. Smith accepted U.S. Magistrate Judge Patricia A. Sullivan’s recommendation to deny a motion to compel arbitration, finding that the attorney representation agreement signed by the couple was not binding because Patton did not initial the arbitration clause.
Johnson then appealed, seeking to enforce the 2007 attorney representation agreement, though Johnson himself did not join the firm until 2013 and did not sign the agreement.
At oral arguments last month, the panel was skeptical as to Johnson’s reasoning.
"Maybe I am missing something, but there seems to be an agreement before the magistrate judge that the law would be Rhode Island," said retired Associate U.S. Supreme Court Justice David H. Souter, sitting on the panel by designation. "So I don't understand why you're briefing Texas law."
Representatives for the parties did not immediately respond to request for comment Monday.
Judges David J. Barron and Bruce M. Selya and retired Associate U.S. Supreme Court Justice David H. Souter sat on the panel for the First Circuit.
Barry Johnson is represented by Samuel D. Zurier of Zurier Law.
Patton and Marquardt are represented by Matthew S. Dawson of Lynch & Pine LLC.
The case is Patton et al. v. Johnson, case number 18-1750, in the U.S. Court of Appeals for the First Circuit.https://www.law360.com/articles/1128065/texas-atty-can-t-arbitrate-malpractice-suit-1st-circ-rules
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