medical devices

RECENT POSTS

FDA Proposes New Restrictions To Address ‘Health Risks’ Of Vaginal Mesh

The U.S. Food and Drug Administration today proposed strict new regulations to address the “clear risks” associated with surgical mesh used to treat vaginal prolapse in women.

Specifically, federal regulators want to reclassify surgical mesh as a “high-risk” medical device (it’s now in the “moderate-risk” category) and also impose more requirements on manufacturers in which they must demonstrate that the device is safe and effective.

The risks and health problems related to this type of surgical mesh, which we’ve detailed here, include infections and nerve damage that can occur when the material erodes through the vaginal lining, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and an end to a women’s sex life.

Here’s the full FDA news release:

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Continue reading

What’s All This Federal Fuss Over An Obscure Medical Device Tax?

A pacemaker device that had been removed from a deceased patient. (Steven Fruitsmaak/Wikimedia Commons)

A pacemaker device that had been removed from a deceased patient. (Steven Fruitsmaak/Wikimedia Commons)

The medical device tax, an obscure component of health reform, is suddenly in the public eye after the House of Representatives chose to attach a repeal of the tax, along with a one-year delay of Obamacare, to a Senate budget resolution to fund the federal government. The move by the House sets up a showdown that may end in the federal government being shut down until a deal can be hammered out — something that hasn’t happened in nearly 20 years.

As lawmakers scramble in Washington, we turned to Brian Johnson, publisher and co-founder of MassDevice.com, an online business journal covering the medical device industry, to tell us what’s up with the tax and why it’s suddenly a hot-button political issue. MassDevice.com has been covering this issue for four years, speaking with lawmakers, medical device CEOs and lobbyists.

So Brian, to echo our headline, what’s all this fuss about the medical device tax?

The medical device tax is a 2.3% excise tax on every sale of a medical device in the United States, except for some consumer products like contact lenses and Band-aids, which are exempt.

The levy was conceived four years ago this month as a way to pay for the Affordable Care Act and has been in place since this January of this year. It’s estimated that the tax will generate about $30 billion in income for the federal government over the next ten years and, since they started making semi-monthly payments to the IRS this January, medical device companies have already paid more than $1 billion to the federal government under the tax, according to a recent report.

However, the tax also has powerful friends. In fact, it has the three most powerful friends you can get in Washington, D.C.

The tax is universally hated by the medical device industry, which has been feverishly lobbying lawmakers to get the tax knocked out, delayed or repealed outright for the better part of four years now.

The tax is also generally unpopular with lawmakers on both sides of the aisle in Washington and has actually already been repealed once by the House of Representatives as a stand-alone bill in June of 2012 by a vote of 270-146, as one of the 44 separate bills the House has passed repealing all of, or parts of Obamacare. The Senate also voted in favor of repealing the medical device tax, 79-20. However, that was a non-binding resolution, which amounts only to a symbolic show of support in the Upper Chamber.

However, the tax also has powerful friends. In fact, it has the three most powerful friends you can get in Washington, D.C. Sen. Max Baucus (D-Mont.) chairman of the Senate Finance Committee, is the father of the tax, having been in on creating the ACA in 2009; his colleague, Senate Majority Leader Harry Reid (D-NV), has no interest in bringing a repeal bill to a vote because he helped broker a deal to cut the tax in half in 2009. And the biggest backer of the tax, President Barack Obama, has promised to veto any bill containing a repeal of the medical device tax.

So is this really worth shutting the federal government down over? Don’t these guys make billions of dollars a year? Why can’t they just pass that 2.3% on to their customers? Continue reading

Buyer Beware: Fraud Alert For Doctor-Owned Device Businesses

The inspector general for the U.S. Department of Health and Human Services has issued a special fraud alert warning about potential financial conflicts in the world of medical devices. Specifically, the warning focuses on medical device distributorships owned by doctors and says such businesses “produce substantial fraud and abuse risk and pose dangers to patient safety.”

doctors2

Bloomberg explains:

Doctor-owned businesses that act as middlemen between medical device makers and hospitals are “inherently suspect” and some of their practices may violate U.S. anti-kickback laws, a government inspector general said.

Daniel Levinson, the inspector general for the Health and Human Services Department, today issued an unusual “special fraud alert” about so-called physician-owned distributorships, or PODs. The companies sell medical devices that the doctor owners then use in surgical procedures on their own patients.
Continue reading

Questioning The True Benefits Of Magnets To Treat Depression

Sometimes, when something seems too good to be true, it is.

An example: this story about an expensive (up to $12,000 for the full treatment), newly-approved medical device to treat depression that involves magnets pulsing repetitively that was published in USA Today last week.

The FDA recently approved the NeuroStar Transcranial Magnetic Stimulation system to treat some people with depression when other therapies have failed. (robertmcdonald1989/flickr)

Though the treatment, called transcranial magnetic stimulation, may help some subset of depressed patients and is now covered by Medicare when other therapies have failed, the expert medical news analysts over at HealthNewsReview.org explain why the USA Today report paints an overly rosy picture of the treatment’s potential effectiveness.

Gary Schwitzer and colleague Harold DeMonaco write that “the story did not provide any semblance of balance in its reporting of the device.” Here’s a bit more from their far-reaching critique:

The story describes a single patient anecdote and does provide us with some information about the NIMH sponsored clinical trial: “Both Cochran and West cite high patient response rates. A clinical trial funded by the National Institutes of Health revealed a “significant effect of treatment” when patients received TMS treatment. It compared outcomes of patients who actually received the magnetic pulses against patients in a “sham” group, who sat down in the treatment chair for fake sessions.”

Here is what the lead author of the NIMH funded study said about the results performed in 190 patients with depression who failed standard drug therapy::

Thirteen (14 percent) of 92 patients who received the active treatment achieved remission, compared to 5 (about 5 percent) of 98 patients who received the simulation treatment.

“…the overall number of remitters and responders was less than one would like with a treatment that requires daily intervention for three weeks or more, even with a benign side effect profile.”

Hardly the results suggested by the story… Continue reading

A New Device For A Chronic Bladder Problem

The LiRIS device delivers (at left 200 mg and at right 650 mg) lidocaine directly to the bladder for pain relief. Image courtesy of Science Translational Medicine/AAAS

By Karen Weintraub
Guest Contributor

The pain of interstitial cystitis can be as unrelenting as the urge to urinate. Some women go 50-60 times a day – and night. They often feel isolated by their symptoms, and misunderstood by their doctors.

The chronic bladder problem, affecting about 300,000 Americans, is known to be tough to treat. It’s unclear what causes flare-ups, with different triggers in different women. (Men can get interstitial cystitis, too, as can children, but it’s much rarer.) It may take years for a woman to get a diagnosis – for a doctor to believe that it’s not just “all in her head” – and years more to find a treatment that works at least some of the time.

“It is a very complicated disease and these patients are in very tough shape,” said Michael Cima, the David H. Koch professor of engineering at MIT. “There’s a real medical need.”

That’s why Cima, along with a company he cofounded, has developed a device to deliver the painkiller lidocaine inside the bladder, for as long as two weeks. Other similar devices are either so large that they cause pain, he says, or so small that they slip out of the bladder when the person goes to the bathroom.

Cima’s device, published in the current issue of Science Translational Medicine, unfurls once placed inside the bladder into a pretzel shape, so it stays put until removed by a doctor.

“This is the first time anybody’s developed a continuous release of anything in the bladder,” he says. “While other people have tried to do this, they weren’t tolerated and ours was.” Continue reading

Report: J&J To Stop Selling Controversial Vaginal Mesh Implants

Pharmalot reports that drug maker Johnson & Johnson will halt sales of several vaginal mesh implants that have been the subject of lawsuits in which women charge that the devices led to painful and debilitating long-term complications. Ed Silverman writes:

In an unexpected move, Johnson & Johnson’s Ethicon unit will halt marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. The devices treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina.
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System – and was disclosed in a pair of letters sent late Monday to judges overseeing different batches of lawsuits – a federal judge presiding over multi-district litigation in federal court in West Virginia and a state judge in New Jersey.

“Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” the J&J unit wrote the judges.

Silverman got hold of J&J’s letters to the judges, which you can read here and here.

We’ve written about the ordeals of mesh victims like Amy Gezon, here. Continue reading

Fresh Disclosures On Vaginal Mesh Implants

http://www.youtube.com/watch?v=rWGDjvceKIk

More revelations about the problems with vaginal mesh implants, which we’ve written about here and here.

Bloomberg reports that Johnson & Johnson sold one early version of the vaginal mesh product before U.S. regulators approved it:

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Enlarge image

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

The Hack-Able Body: Raising Big Questions About The Medical Devices Inside You

(Double-M/flickr)

A thought-provoking piece on MassDevice.com asks the question: Are medical device makers doing enough to shield patients from hackers?

The story, by Arezu Sarvestani, details the case of a young woman diagnosed with a heart condition that requires a device be implanted in her chest to monitor her heart rate, and shock it back to normal if needed. It sounds good, but the tech-savvy patient, Karen Sandler, begins to wonder about all the implications of having a computer in her body:

Even as a self-professed “technology warrior,” the prospect of becoming part machine caught Sandler off guard. Computers crash, run out of power and succumb to hackers. Would becoming a “cyborg” ultimately count as an affliction or an upgrade? And could she really trust a machine with her life…

Sandler wasn’t ready to trust her heart to a program she hadn’t seen. Her work with open-source computer software had taught her that the best way to detect bugs and fix them is to tap the wisdom of the crowd through open-source programming. Open-source projects allow the world to view a copy of machine’s source code, the underlying instructions that tell the device what to do. In terms of an implantable defibrillator, that would mean making public a copy of the code that tells the device when to provide a shock and how much shock to provide, as well as how to monitor the heart rate and log unusual events. Modern heart devices can communicate wirelessly, so the software is additionally responsible for prescribing how a machine sends and receives signals and how it determines whether a signal is authorized to access the machine. While an individual person’s device needn’t be open to the world, a circulated copy can gather comments and suggestions that the device manufacturer can choose to adopt or ignore…

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FDA Orders New Testing On Vaginal Mesh Products, Cites Safety Concerns

http://www.youtube.com/watch?v=rWGDjvceKIk

The Wall Street Journal reports that the FDA has ordered the makers of vaginal mesh to conduct clinical studies to further track potential side effects and determine whether the products — which have been used in hundreds of thousands of women — are safe.

The Food and Drug Administration is ordering manufacturers of surgical mesh to conduct new studies of the products when used to treat two conditions affecting millions of women—pelvic organ prolapse and stress urinary incontinence— amid concerns about the products’ safety.

The move is the first step toward tighter regulation of the mesh when inserted through the vagina to repair pelvic organs, a less-invasive procedure than traditional surgery. Surgical mesh was initially developed to repair hernias in the 1950s but doctors later adapted the mesh for other uses. Continue reading

Surgeons Challenge FDA Warnings On Vaginal Mesh

The debate over a controversial medical device used for women is heating up.

A nationwide coalition of pelvic surgeons is challenging a recent U.S. Food and Drug Administration safety advisory that warns of serious risks, complications and questionable benefits of surgical mesh implanted vaginally to treat women for a condition known as prolapse. The procedure is used to strengthen vaginal tissue that has grown weak or stretched, often after childbirth.

In advance of an FDA advisory panel meeting Sept 8-9 to discuss the safety and effectiveness of the mesh — and as attorneys across the country intensify their efforts targeting the device through litigation — pelvic surgeons say they e-mailed a response letter to the FDA outlining their concerns. A copy of the letter was obtained by CommonHealth.

“We have some significant disagreement with the conclusions reached [by The FDA] and concerns regarding the message that it is sending to our patients, the healthcare community, and unfortunately to the legal community as well,” says the Aug. 25 letter, which is signed by more than 600 pelvic surgeons, according to one of the organizers, Dr. Miles Murphy, associate medical director at the Institute for Female Pelvic Medicine & Reconstructive Surgery and Director of the Division of urogynecology at Abington Memorial Hospital in Pennsylvania. Continue reading