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Articles from 2016 In February


Essure Gets Boxed Warning

Essure Gets Boxed Warning

Marie Thibault

After months of consideration, FDA has revealed next steps in its oversight of Essure permanent birth control. The agency is requiring maker Bayer to add a boxed warning and patient decision checklist to Essure labeling, as well as run a new postmarket surveillance study of the device. Patient activists, who have campaigned for a ban, expressed their displeasure Monday at FDA's decision to leave Essure on the market.

The Essure system, owned by Bayer following its 2013 acquisition of Conceptus, received FDA approval in 2002. The system involves hysteroscopic placement of nickel-titanium alloy inserts into the fallopian tubes, which, with tissue ingrowth, block the fallopian tubes and result in permanent birth control.  

In a press release Monday, FDA acknowledged that some Essure patients may be at risk of serious complications such as "persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions."

The agency published draft guidance, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization," detailing a mandatory warning that will be added to the Essure product box, as well as language that explains the potential for serious adverse events. Also included in the draft document is a checklist that is intended to be discussed and signed by patients and physicians before undergoing Essure or any other permanent hysteroscopic sterilization procedure. FDA wrote, "Each separate item in the body of the checklist should be accompained by a line for the patient to initial her acknowledgment and understanding of that individual piece of information."

This draft guidance is open to public comment for 60 days. FDA's actions follow a meeting of the Obstetrics and Gynecology Devices panel in September 2015.

FDA is also requiring Bayer to design and run a post-market surveillance study "to help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation." These study results will be reviewed by FDA to decide if any other steps are necessary. 

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, MD, MPH, deputy director for science and chief scientist at CDRH in the press release. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.” 

Essure Problems, a grassroots group representing women who have had the Essure procedure and experience side effects that may be attributed to the device, wrote in a release,

We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies. Clearly Essure's PMA should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women's lives at risk. We have provided the FDA with enough relevant data to prove that Essure is unsafe. Take the device OFF the market and revoke PMA. Do not continue to allow more women to be harmed . . . "

In a statement, Bayer said it "will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure." Dario Mirski, MD, senior vice president and head of medical affairs of Americas at Bayer, said in the company's statement, "Patient safety and appropriate use of Essure are our greatest priorities. A woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure."

Rep. Mike Fitzpatrick (R-PA), who introduced the E-Free Act on the House floor last fall to take Essure off the market, also expressed disappointment with FDA's actions. "It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market," he said in a releaseHe added, "Frankly, I'd contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering."

Fitzpatrick said he plans to keep pushing for Congress to pass the E-Free Act, will try to prevent government agencies "from purchasing this unsafe device," and will introduce a new bill to get rid of "blanket civil liability protections that device manufacturers like Bayer currently receive for a non-life-saving device like Essure because those harmed deserve a voice in court."

Get inspired to innovate during Massachusetts Medtech Week—register for BIOMEDevice Boston 2016, April 13-14.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie

[Image courtesy of IDEA GO/FREEDIGITALPHOTOS.NET]  

FDA Recommends Stronger Warnings for Essure

Facing pressure from politicians and patients advocates, the agency is recommending more testing for the controversial Essure birth control product as well as a restrictive warning.

Qmed Staff

Essure

Bayer AG to perform more studies on its Essure birth control device, a coil-based fallopian tube implant. FDA is also recommending that the product carry a black box warning (describing the possibility of possible serious or life-threatening injuries) and that doctors use a patient-decision checklist to make sure that women treated with the device understand its potential risks.

"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," William Maisel, MD, deputy director for science and chief scientist at the FDA's CDRH said in a statement. In a press meeting, Maisel stated that the agency believes that "informed women should have [Essure] as an option available to them."

While the FDA statement doesn't go into detail, it does mention that the agency believes that certain women may face a heightened risk for complications and that "more rigorous research is needed" to determine which women are.

The device has been promoted as as a less invasive alternative to tubal ligation. Scar tissue forming around the device after implantation is intended to prevent fertilization from occurring.

The aforementioned patient checklist would include criteria to determine if a "confirmation" test  is required to determine if scar tissue around the implant has indeed formed to prevent pregnancy.

While the FDA believes that Essure is an appropriate treatment option for many women, some patients treated with the device have reported problems like chronic pain, bleeding, allergies, or autoimmune disorders that have persisted even after the device is explanted. Some women also

In September, FDA had instructed Bayer to perform more thorough post-market surveillance of the product. The agency plans on using this study to determine if further regulations are required.

The agency is accepting comments on the guidance document over the course of the next 60 days.

FDA has received thousands of adverse events linked to the devices. Recently, Rep. Michael Fitzpatrick, R-PA, has accused FDA of underreporting the number of adverse events related to the device, stating that the company counted had counted five fetal deaths linked to the device when there were really 303 fetal deaths. Bayer disagreed: "It is not true that an investigation revealed 'unreported' deaths with Essure," a Bayer spokesperson said in a statement.

Fitzpatrick clearly didn't like FDA's recent decision. "It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market," he was quoted saying in the Washington Post.

Fitzpatrick is the sponsor of the H.R.3920 - E-Free Act, legislation that would require FDA to pull Essure from the market.

In a Philly.com article, Fitzpatrick had criticized FDA's response time at dealing with injuries caused by dangerous devices to be "excruciatingly slow and ineffective in withdrawing something from the market."

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Toshiba's Sale of Medical Unit Could Fetch Billions

Still reeling from an accounting scandal, the Japanese company feels pressured to sell off one of the few bright spots in the company: its medical division. The sale could be worth billions of dollars.

Qmed Staff

Toshiba MRI
Toshiba's roughly $3.5-billion-a-year medical business makes diagnostic imaging equipment, such as the MRI machine shown above. (Image courtesy of Toshiba Medical Systems)

The medical device industry could be losing one of its giants. Struggling Toshiba, which had planned to sell part or all of its medical equipment business, now plans to simply sell the whole thing, according to Reuters, which cited people familiar with matter.

The Reuters sources thought that aggressive bidding could boost the sales price above the previous estimates equivalent to $3.5 billion. It is a cash infusion the Japanese giant sorely needs.

Prospective buyers include buyout firm KKR & Co., Canon Inc., Fujifilm Holdings Corp., and Konica Minolta Inc., according to Reuters. The deal would mark the latest chapter in the medtech merger frenzy that is shifting the landscape of the medical device industry.

Toshiba first announced in December that it was shopping around its medical device business, which brings in about $3.5 billion a year in sales.

The healthcare business--which makes diagnostic imaging equipment covering everything from MRI to CT, ultrasound and X-rays--is one of the few areas of the company that has been clocking in operating income. Sales are up as the business' mainstay CT and imaging systems see firm sales in the North American service sector and Chinese equipment sector, according to Toshiba's most recent quarterly report. Operating income was down, but only because the medical device business has been increasing its investment in R&D.

The overall company, meanwhile, continues to up its projections when it comes to fiscal year losses. Toshiba in early February said it expects a net loss of 710 billion yen (equivalent to $6.3 billion) for the fiscal year ended March 31. It is an increase in losses from the previous projection of 550 billion yen (equivalent to $4.9 billion) made in December.

Toshiba is seeking to claw its way back from an accounting scandal involving nearly $2 billion in overstated profits over the past seven years. The company has been engaging in a massive restructuring. Toshiba previously announced that 10,600 workers--about a fourth of the company's global workforce--are losing their jobs.

Toshiba's stock is one of the worst performing among major medical device companies. It is presently trading around 175 yen ($1.55) per share, less than half of the roughly 500 yen ($4.44) per share it was trading for a year ago.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

What's on Commissioner Califf's To Do List?

What's on Commissioner Califf's To Do List?

Now that Robert Califf is in the top spot at FDA, what issues top his list of priorities?

Marie Thibault

Last week, the Senate confirmed Robert Califf, MD, MACC as FDA's commissioner of food and drugs. As Califf takes the helm at the agency, he has said there are a couple issues related to medical devices—electronic health records (EHRs) and a medical device surveillance system—he plans to tackle.

In his statement to the Senate Committee on Health, Education, Labor, and Pensions (HELP) in November, Califf called the widespread use of electronic health records and smart phones an "astounding opportunity" and said that FDA plans to create a medical device surveillance system similar to the Sentinel system for drugs. "I am committed to the development of a national system for surveillance and evidence generation that will improve patient safety and provide a much more efficient way to understand the benefits and risks of medical products when used in practice," he told the Senate HELP committee.

Califf

Califf reiterated his interest in electronic health records as an evidence generation tool in an interview published in The Washington Post last week, saying, "This is an unprecedented time of evidence generation, ranging from genomic medicine to use of social media to the astonishing opportunity with electronic health records. We really want to bolster the scientific infrastructure at FDA and take advantage of the opportunity that we have to have much better evidence."

Califf elaborated on the importance of data and the link to "real-world evidence" in a co-authored December 10 FDA Voice blog post. He wrote that while there are challenges in interpreting data from sources like EHRs, claims databases, and patient registries, "the incorporation of 'real-world evidence'—that is, evidence derived from data gathered from actual patient experiences, in all their diversity—in many ways represents an important step toward a fundamentally better understanding of states of disease and health." 

Get inspired to innovate during Massachusetts Medtech Week—register for BIOMEDevice Boston 2016, April 13-14.

In a February 29 letter to the new commissioner, Allan Coukell, senior director of Health Programs at The Pew Charitable Trusts, applauded Califf's interest in a device postmarket surveillance system and his support of linking unique device identification (UDI) to Medicare claims. "Congress has required that FDA expand the Sentinel model to device, but this has not been possible to date as insurance claims do not contain identifying information about devices, as they already do for drugs," Coukell wrote. 

Coukell asked Califf to "emphasize to CMS the importance of immediate action, as the standard insurance claims form is currently undergoing revisions . . . Your leadership, in conjunction with action by CMS, will ensure that this important step toward device safety surveillance is achieved."

Ahead of Califf's device-related priorities, however, is his first goal of "strengthen[ing] and better support[ing] FDA's talented and dedicated workforce," as he told the HELP committee. Employee turnover has been an issue at the agency. In March 2015, then-commissioner Margaret Hamburg told the HELP committee that the workload at FDA contributes to talent retentions challenges, since employees "are stretched very thin."

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie

[Images courtesy of STUART MILES/FREEDIGITALPHOTOS.NET and FDA]  

Where the 2016 Presidential Candidates Stand on Healthcare

Where the 2016 Presidential Candidates Stand on Healthcare

As the motley cast of 2016 presidential candidates dwindle in number, it's time to take a closer look at the remaining contenders' plans for the nation's healthcare system. 

Arundhati Parmar

Super Tuesday is upon us and the dwindling set of 2016 presidential candidates makes it a perfect time to delve into where they stand on healthcare.

On the Republican side, most of the candidates want to dismantle Obamacare, or the Affordable Care Act. On the Democratic side, Hillary Clinton wants to continue the policies of President Obama, while Bernie Sanders believes in a wholesale transformation of the current healthcare system to a single payer system.

For more detail on the plans that each candidate has on healthcare, see the slideshow below, which is in alphabetical order.

 

Begin Slideshow 

 

[Photo Credit: iStockphoto.com user pagadesign]

Where the 2016 Presidential Candidates Stand on Healthcare - Donald Trump

 

Party: Republican

Wants to Repeal Obamacare: Yes

 
Replace With: Business man and real estate developer Donald Trump is the only other presidentical candidate, apart from Senator Ted Cruz from Texas, who doesn't address healthcare under the "issues" tab on his website.
 
A September 2015 clip of Trump on 60 Minutes that he wanted government to pay for healthcare for everyone, but now he denies ever having said that. Like some other Republicans, Trump wants people to be able to buy insurance across state lines.
 
That in effect will create a robust, competitive marketplace that will make insurance coverage affordable. 
 
"It will be beautiful," Trump said to a debate audience in Houston last week.
 

Source: Official Trump for President Website, CNN 

            

Back to Beginning

Photo Credit: Getty Images

 

Where the 2016 Presidential Candidates Stand on Healthcare - Bernie Sanders


 
Party: Democratic
 
Wants to Repeal Obamacare: Yes
 
Replace With: The senator from Vermont wants a single-payer national healthcare program — in short, he calls it a Medicare for all. He views Obamacare as a critical step forward to achievning universal healthcare, but one that doesn't go far enough.
 
Like some Republican presidential candidates, Sanders wants to divorce healthcare coverage from employment. Sanders also believes that going the single-payer route would also stem the spiralling costs of healthcare. It would give the government a firmer footing to negotiate better prices from drug companies. 
 
Under Sanders, premium costs will be cut significantly under the plan for individuals while employers also will see a radical reduction in their burden. Sanders intends to pay for his single-payer universal healthcare plan by making employers pay a 6.2% income-based healthcare premium, households pay 2.2% income-based premium and progressive income taxes based on wealth as well as other mechanisms.
 

Source: Official Bernie Sanders For President Website

              

Photo Credit: Getty Images

 

Where the 2016 Presidential Candidates Stand on Healthcare - Marco Rubio

 
 

Party: Republican

Wants to Repeal Obamacare: Yes

Replace With: The senator from Florida wants to bring consumer-centered healthcare. He aims to bring affordable, quality health coverage by providing every American with an advanceable, refundable tax credit which they can use to buy insurance.
 
Rubio wants to specifically repeal the cuts to Medicare Advantage and the medical device tax — which now has been temporarily paused for two years — that are part of the Affordable Care Act. 
 
He also wants to ensure that when the ACA or Obamacare is repealed, people with pre-existing conditions get coverage, similar to what the current law has put in place. Rubio wants to increase innovation in the Medicaid program by giving states a per-capita block grant, that would keep funding for the Medicaid population while freeing states from Washington mandates.
 
Rubio intends to undertake insurance regulation reform to lower costs.
 

Source: Official Marco Rubio website

              

Photo Credit: Getty Images

 

Where the 2016 Presidential Candidates Stand on Healthcare - John Kasich

 

Party: Republican

Wants to Repeal Obamacare: Yes

Replace With: The govermor of Ohio wants to engage in primary care reform and expand what the state has achieved on a national level. Ohio won a federal grant to implement a payment model tied to the creation of patient-centered medical homes that involves a team-based approach to primary care. The goal is preventive care which is far cheaper to the healthcare insurers than having to manage chronic diseases down the road.
 
In March 2015, the state's  four largest commercial insurers—Anthem, Aetna, Medical Mutual and UnitedHealthcare—as well as Ohio’s five Medicaid managed care plans, said they are designing a system that will share some of those savings with healthcare providers who are adding value by improving health outcomes and holding down costs. In effect this awards value, not volume, which is what the healthcare system is currently moving toward, as a result of Obamacare. 
 
The Ohio governor has also expanded Medicaid under the Affordable Care Act unlike some other Republican governors. 
 

Source: John Kasich for America

              

Photo Credit: Getty Images

 

The U.S. Healthcare Reimbursement Model is Killing Medtech Innovation

The U.S. Healthcare Reimbursement Model is Killing Medtech Innovation

In addition to driving up healthcare costs, the third-party payer system in the United States is detrimental to medical innovation.

Jamie Hartford

The way healthcare in the United States is delivered, including what goods and services get paid for, is undergoing unprecedented change thanks to factors ranging from the Affordable Care Act to provider consolidation. But one thing that hasn’t changed much and isn’t likely to anytime soon is who pays for our healthcare. Unless voters elect Bernie Sanders—the only 2016 presidential candidate advocating a single-payer national healthcare system—to the White House come November, the third-party payer system is probably here to stay. 

Critics argue that this model is responsible for giving the United States the dubious distinction of having some of the highest healthcare costs in the world. In fact, the United States spent more per capita on healthcare—$9086—in 2013 than 12 other high-income countries, including France, Switzerland, Germany, Australia, and Canada, according to a report from the Commonwealth Fund. Yet despite throwing all that money around, we also have the lowest life expectancy and some of the worst health outcomes among the other relatively wealthy nations studied. 

Learn more about how to gain reimbursement for your medical device at the BIOMEDevice Boston conference, April 13-14, 2016.


I would argue that the third-party payer system also hurts Americans in another way: It’s holding back medtech innovation. 

At the MD&M West conference in Anaheim, CA, last month, Betsy Gross, vice president of healthcare economics and reimbursement at Intersect ENT, shared a hypothetical story about an imaginary tympanostomy device to illustrate why medical device developers should consider their reimbursement strategy early on. But to me, her tale also underscores how the healthcare payment model in the United States is detrimental to innovation.

Gross asked the audience to imagine a medical device that would allow the common procedure of placing tubes in children’s ears to move from the hospital operating room to a physician’s office and eliminate the need for the patient to undergo general anesthesia. Sounds like a winner, right?

Not so fast. As Gross explained, a device like this probably wouldn’t hold up when exposed to the realities of our third-party payer system.

Because payers dole out a fixed sum for tympanostomies, providers have gotten good at maximizing throughput. Thus, moving the procedure to the physician’s office would cut off an important revenue stream for hospitals. Not putting patients under could also make the procedure take longer, which would lower the hourly rate providers receive for their work. Finally, payers have already negotiated the rate paid to hospitals for tympanostomies so low that it’s unlikely the payment to a physician’s office would be much less. As a result, Gross said, such a device would likely fail to catch on.

Is it just me, or is that madness? A device that’s better for patients than the current standard of care could never see the light of day simply because it doesn’t play nice with our convoluted reimbursement model.

While Gross’s example was make-believe, another speaker explained how this is playing out in real life.

Utah-based startup Owlet Baby Care has created a pulse oximetry system to alert parents if their baby stops breathing. Although Sean Kerman, Owlet’s vice president of clinical strategy, said the company has received feedback from nurses who say its device is easier to use than some of the equipment they have access to in the neonatal intensive care unit, Owlet is initially marketing the device only as a health and wellness product sold directly to consumers. That decision was made partly because going through FDA would have lengthened the development cycle, but also because Owlet wanted to ensure parents could get access to its product. 

“. . . You run the risk that some people won’t have [the device] covered by insurance, and they won’t be able to purchase it because it’s behind some kind of Rx channel,” Kerman said. 

He admitted that Owlet is pursuing a reimbursement strategy, but his comment begs the question: How many medical innovations are we missing out on because of our messed up reimbursement model? 

It's enough to make you feel the Bern. 

Jamie Hartford is MD+DI's editor-in-chief. Reach her at [email protected] or on Twitter @MedtechJamie.

[image courtesy of THE CREATIVE COMMON LICENSE AT WIKIMEDIA COMMONS]