April 9, 2013 ~

It’s been noted that some hip implants have an early failure rate in women and surgical mesh appears to have a high complication rate, though no one is actually tracking that at the present time.

The stated goal is to improve the:

•  Availability, consistency and communication of sex-specific information for the safe and effective use of medical devices in women

• Addressing identified gaps and unmet needs through targeted resources

• Fostering the development of innovative strategies, technology and clinical study paradigms

Much of the focus seems to be how to address research areas and talk to women being recruited for research. Meanwhile thousands of women injured by medical devices seem to have no audience with the FDA at the present time, other than entering their “adverse event” into the MAUDE database.

See how to do that here.

The workshop is being held by the division that overseas medical devices the Center for Devices and Radiological Health (CDRH) and those interested can attend in person or via webinar.   Patients and patient advocates are invited to attend in person or by webcast, however a webcast does not allow access to breakout sessions.  Register by June 14.

Date, Time and Location

The meeting will be held on June 24 and 25, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus, Building 66
Rooms G512 and G514
10903 New Hampshire Avenue
Silver Spring, MD, 20993

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Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were victims of surreptitious surveillance and a violation of their rights to privacy.

MDND Background story is  here and here.

Judge James Boasberg found about 1,500 documents, which the NWC had sought from the FDA, were properly withheld or redacted because they did not contain information on “government impropriety.”

The NWC had been fighting to obtain the documents, but the FDA argued they might contain trade secrets of the companies they monitor.

The Freedom of Information Act (FOIA) allows documents to be withheld when they contain company trade secrets, any attorney-client privileged information, and personal information that could be considered a violation of privacy. These types of documents can be withheld, but only if there is no evidence of government wrongdoing.

Boasberg wrote the documents “Do not approach the level of misconduct contemplated by these cases with respect to either improper approval of medical devices or retaliation against FDA employees.”

The employees, who were in the medical devices division, wrote to Rep. John Dingell in an October 14, 2008 letter (these are excerpts) :

“The U.S. Food and Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.

“Managers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE).

“There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices.

“Managers at CDRH with no scientific or medical ex~_ devices, or any clinical experience in the practice of medicine.__,have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements. To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.

“At the same time, there is a need for new legislation that modernizes the regulatory structure of the 510(k) program so that complex medical devices are not allowed onto the market without a comprehensive (or in some cases, any) clinical evaluation of their safety and effectiveness.”

Meanwhile the case, now in its 14^th month continues. NWC had obtained thousands of documents related to the case and the Department of Justice, on behalf of the FDA, has filed a motion to dismiss the case which will be heard in December.

The case is filed as Hardy et al v. Shuren et al here.

Here is the letter October 14, 2008 by 11 whistleblowers to Rep. John Dingell concerning mismanagement at the FDA’s CDRH. It’s a pretty interesting read.

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Dr. Jeffrey Shuren, CDRH

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in for.

What industry wants is another story.

Jeff Shuren, who heads the medical device unit of the Food and Drug Administration (FDA) told a life sciences industry group Monday, June 11, that medical device reviews are becoming faster and more efficient and less politically motivated, reports Mass Device.

“Our vision, what we should be trying to do, is to ensure that patients in the U.S. have access to high-quality, safe and effective devices of public health importance, first in the world,” Shuren said. “The good news is we’re seeing the canary in the coal mine is actually singing these days,” Shuren said. “As we start to then implement more of the things we have under way and have additional dollars under [MDUFMA], I think we’re heading in the right direction.”

Shuren, who heads the Center for Devices and Radiological Health (CDRH), said the agency is seeing fewer device approval applications being rejected and the approval time shortened.

Lawmakers hammered Mr. Shuren last February over the time the FDA takes to review a new medical device. Members of the House Committee on Energy and Commerce criticized the agency as dragging its heels on device approval with many on the committee advocating on behalf of the interests of the medical device industries.   (See background story here).

Both the House and the Senate have signed off on the Medical Device User Fee & Modernization Act, (MDUFA) which budgets the FDA for medical device reviews by charging industry a user fee. The $595 million for the next five years represents a doubling of the last budget. The House and Senate must reconcile their versions of MDUFA before sending it onto President Obama for his signature.

However, the House voted version failed to approve legislation that would protect Americans from defective medical devices such as surgical mesh, metal-on-metal hips and defibrillator leads.

In February, Rep. Edward Markey introduced H.R. 3847 the Safety Of Untested and New Devices, Sound Devices Act that would have given the FDA the authority to put the brakes on the approval of a medical device that names as its “substantial equivalent” an earlier device that’s been found to be defective or has been recalled. The authority was also championed by Consumers Union and its Safe Patient Project.

In a poll, Consumers Union asked consumers if safe medical device approvals were at the top of their list.

The poll revealed:

•  82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
• 91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.
• 71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
• 95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
• 66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

Learn More:

Consumers Union – Safe Patient Project Poll
http://safepatientproject.org/posts/3053-consumer-reports-poll-americans-want-strong-medical-device-safety-oversight

MDND – May 14, 2012, FDA Closer to Funding Goals – Where is Patient Safety?
http://meshmedicaldevicenewsdesk.com/fda-notices/fda-closer-to-funding-goals-where-is-patient-safety/

MDND, Feb 22, 2012 – Observations on How Lawmakers View Medical Device Regulation
http://meshmedicaldevicenewsdesk.com/opinion-editorial/jim-shull-observations-on-how-lawmakers-view-medical-device-regulation/

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Sen.Chuck Grassley

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be tolerated.”

Those are the words of Sen. Chuck Grassley (R-Iowa) in a letter to FDA Commissioner Margaret Hamburg, MD concerning the monitoring of certain employees who chose to publicly expose what they believed were unethical practices of approving medical devices.

 Here is his letter.

Cardiovascular News reports (here) the senator was referring to one the ‘FDA Nine’, P.J. Hardy, who with the others wrote to the incoming Obama transition team in 2009 that laws were being disregarded and inadequate reviews were being conducted of medical devices within the agency.

The senator says the FDA accessed Hardy’s emails in retaliation, intentionally tried to damage his reputation to other government entities, and sought his dismissal. Among other things, the CDRH (Centers for Devices and Radiological Health) management said that Hardy had released confidential and classified information and that’s when management began monitoring his government email account.

“Based on the information we are providing your office, CDRH management cannot allow LTJG Hardy to continue to work in our organization. We simply cannot trust him,” said one a memo to the Office of the Surgeon General.

Hardy also had his personal email account monitored. Eventually Hardy was placed on a “Non-Duty with Pay” status.

Sen. Grassley asked Hamburg:

• Who authorized the monitoring of all the whisteblowers’ email accounts for communications with Congress?

• Did the FDA monitor all employee email accounts, including personal accounts, or was the monitoring targeted only at the nine whistleblowers?
• Did the FDA obtain the passwords to employees’ personal email accounts, which would allow emails to be intercepted even when not sent or received from a government computer?

About six of the “FDA 9” whistleblowers are suing the agency for illegally spying on their private email in retaliation after they warned lawmakers that unsafe medical devices were being approved for market. Here is the complaint filed by the law firm.  #

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Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market.  You may recall as President Obama was taking office on January 7, 2009, nine scientists alerted him to the internal problems, accusing the agency of acting illegally by approving flawed and defective medical devices for sale even when others within the FDA objected because of safety issues. One medical device  cited as problematic was the computer-aided breast mammograms, “the FDA approved the devices anyway in a flawed process that ignored the science. This had led to significant harm to large numbers of women and significant unnecessary costs to the public.”

After that the staffers said the FDA spied on their private emails, harassed them and in some cases fired the whistleblowers. Internally the group was known as the “FDA Nine”.

The federal lawsuit filed in the District of Columbia charges the agency with 12 counts and names FDA chief Margaret Hamburg, M.D., Jeffrey Shuren, M.D., William Maisel, M.D., and HHS chief Kathleen Sebelius accusing them of retaliation, among other things:

“Defendants have taken and converted private emails without due process or just compensation in violation of the 5th Amendment of the United States Constitution. Defendants have initiated searches and seizures in violation of the 1st and 4th Amendments. Defendants have conducted searches and seizures of a scope that violates the 1st and 4th Amendments. Defendants have violated the 1st Amendment by chilling free speech with searches and seizures. Defendants have violated the 1st Amendment by chilling Plaintiffs’ and the public’s right to associate with whistleblowers. Defendants have violated plaintiffs’ right to representation. Defendants have chilled plaintiffs’ protected 1st Amendment right to free speech.”

Mass Device reports there is a question whether or not the government can surveil any private email activity if it is carried out on government-issued computers.

The complaint says that the plaintiffs, “had a reasonable expectation of privacy in their private, password protected, non-Governmental, encrypted email communications when these communications were sent from or received on computers or networks that the FDA had explicitly stated could be utilized for personal communications.”

The complaint points out that private email accounts were also used for personal banking, attorney-client privileged communications and other sensitive personal issues.

Computer screen shot of FDA whistleblower email

Whistleblowers Warned the President

As President Obama took office, the whistleblowers said that several staff scientists and managers should be held accountable for wrongdoing for allowing unsafe devices on the market.

They also wrote to Rep. John Dingell in October 2008. MDND has a copy of that letter (here) which says:

“There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices…… Managers at CDRH with no scientific or medical ex~_ devices, or any clinical experience in the practice of medicine.__, have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements. To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law. Furthermore, these managers have also ordered, intimidated and coerced FDA experts to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.”

And more

“At the same time, there is a need for new legislation that modernizes the regulatory structure of the 510(k) program so that complex medical devices are not allowed onto the market without a comprehensive (or in some cases, any) clinical evaluation of their safety and effectiveness. This is especially true for _ devices due to their markedly increased use in clinical practice and because” devices employ highly complex hardware and software, undergo rapid technological changes and touch the lives of so many patients on a daily basis. The current framework for medical device adverse event reporting does not work for many _ devices as the adverse effects of devices are rarely detected immediately, are not transparent on an individual patient basis, and can only be prevented by a rigorous pre-market evaluation process.”

Staffers of Sen. Charles Grassley (R-Iowa) reportedly warned the FDA against retaliating, but the Washington Post reports the FDA asked the HHS to investigate the whistleblowers for the disclosure of confidential manufacturer information. The Inspector General’s office failed to get involved.

Kohn, Kohn and Colapinto represent the whistleblowers on behalf of the National Whistleblowers Center, (here) which has the complete set of documents including the complaint (here) filed by the law firm:

Here is Washington Post on their set of documents including the original letter to President Obama.

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Ruptured PIP Implant from Beverly Hills Plastic Surgery

Many in the United Kingdom assume that an implanted medical device is reviewed for safety before it is permanently placed inside a patient. They would be wrong. The Guardian reports (here) that the European quality standard – the CE mark – represents an assurance that is the same whether the product is a breast implant or a Chinese-made yo-yo.Assurance of Quality Medical Devices?

Europe offers consumers many of the same products as the U.S. and the move in recent years has been to reduce the cost of manufacturing. That’s why Allergan’s breast implants, which were made in Ireland, are now manufactured in Costa Rica which can give a CE mark. The defective breast implants made by PIP (Poly Implant Prothese) did not receive a CE mark in France but rather in Germany, a location chosen by the manufacturer. The Guardian reports that PIP was alerted 10 days before inspectors would come to the plant.

Jean Claude Mas, Sky News

Regardless, the inspectors never found the owner of PIP, Jean Claude Mas, was buying a cheaper agricultural and industrial-grade silicone to fill the implants.

And just like in the U.S., it is up to the manufacturer to decide whether to report a serious problem to health authorities. The Guardian reports among employees of PIP, a ruptured breast implant was not considered serious enough to be reported to authorities, in that case the Medicines and Healthcare Products Regulatory Authority (MHRA). The MHRA licenses drugs but does not approve medical devices and it can’t stop those that have a CE approval from being marketed. It is supposed to send out letters to doctors about risks and benefits.

Reviews for medical devices are carried out by about 70 for-profit companies not regulators. In the U.S., the FDA’s Center for Devices and Radiological Health handles reviews, though most medical devices are put on the market with a 510(k) application claiming equivalence to a device already marketed.

Europe has taken a tougher stand than the U.S. issuing an ethical code in 2008 that prevents doctors from receiving lavish trips from major manufacturer. But the UK did approve a Covidien lung sealant and an elbow fracture treatment that were never approved in the U.S.

Thousands of UK patients have also received the metal-on-metal artificial hip implant made by Johnson & Johnson’s DePuy which is now under  recall since last September.

Many believe the UK system of device regulation is tougher than the U.S. which is ironic then that many U.S. manufacturers threaten to take their products overseas for approval unless the FDA lessens the regulation of U.S. medical devices. Members of Minnesota’s congressional delegation wrote a letter to the FDA last October urging a speedier approval process for medical devices or else jobs and industry innovation would go overseas.  See the letter here.

The PIP founder was arrested Thursday, January 26 at his villa in the south of France. The French government has advised 30,000 women to have their defective breast implants removed.

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Understanding Barriers to Medical Device Quality

See the report here.

In 2001 medical devices were a $73.6 billion industry. By 2009, that had grown to $147.6 billion. And while the  medical device industry has seen tremendous growth in the last several years, the FDA report says the complication rate from those devices has outpaced the growth of the industry.

30,000 Medical Devices

During those years more than 30,000 medical devices were cleared through the 510(k) process, a fast track approval for marketing procedure where the manufacturer claims the device is substantially similar to a medical device already on the market despite rapid advances in technology and innovation in materials.

At the same time there were 303 new devices that were required to undergo premarket approval (PMA), the closer scrutiny for safety and efficacy.

No surprise then that serious adverse event reports have outpaced the industry’s growth by 8% a year every year since 2001.

Hospital/ surgical devices and cardiovascular devices account for nearly 60% of those complications, the report says.

Medical Device Failures

Failures in the design of the product and in manufacturing caused more than half of medical device recalls.

The volume of adverse events as measured on the MAUDE database (Manufacturer and User Facility Device Experience) are on the rise about 15% a year. With 1.2 million records on MAUDE from 1998 to 2009, the adverse events sharply increased to 22% a year from 2005 to 2009. Life-threatening or death, disability and hospitalization rose 17% during that time.

In 2009, there were 28,000 serious complications from U.S. medical devices

Editors Note – The MAUDE database is thought to reflect a serious  under-reporting of  complications because consumers don’t know MAUDE exists and it is not terribly user-friendly requiring detailed information about a medical device many patients do not have.

Doctors may be reluctant to report complications, though under the Medical Device Reporting regulations of the FDA they are supposed to. See here.

Recalls

Recalls have not kept up with the adverse event reports. For example in 2003 there were 540 recalls, in 2009 there were 763 recalls with an annual increase of 6%.

Class III are high risk devices generally considered essential for sustaining life.  Class III devices in 2003 were responsible for 27% of adverse event reports and by the year 2009, responsible for 40% while recalls shrank from 17% in 2003 to 7% in 2009.

Surgical Mesh

Surgical mesh is a Class II moderate-risk medical device and that is the class responsible for 52% of complications in 2009.

Synthetic surgical mesh is in the Top 20 product codes for serious adverse events, though at 1,311 events far behind 14,016 for an insulin pump or 10,917 for a coronary drug-eluding stent. Many devices that have caused serious harm have been recalled while most types of polypropylene surgical mesh products remain on the market.

Troubling Devices

The FDA tracks “problem codes” that is the Top 20 device product codes to determine the most serious adverse events with 11 of the 20 associated with cardiovascular devices (stents, grafts, defibrillators). The FDA does not correlate codes to the specific description of a problem such as death.

The medical device industry says it resents what it perceives to be the “policeman mentality” of regulators driven by negative PR while the European Union is seen as being more “collaborative” and friendly, says the report.

Solutions

Correlating the 989 product codes with patient outcomes would “enhance transparency” as the FDA likes to say and give the agency a better handle on what’s going on with a problematic device.

With so many patients suffering from adverse events due to medical devices, the authors of this report said they wanted to get a better handle on lapses in safety and quality and so they interviewed medical device “thought leaders” and FDA leadership as well as analyzed FDA adverse event reports and data.

Here are the participants – Heather Howell- moderating; Jeff Shuren, Dir. CDRH, Steve Silverman, Dir. Office of Compliance, CDRH;  Donna Godward Chief Quality Officer Medical Devices, Johnson & Johnson; Ted Fuhr, McKinsey and Co.; Luann Pendy, PhD Medtronic; Liz Blackwood, GM GE Healthcare; David Elder, Dir. Office of Regional Operations, FDA.

The exchange can be seen on an FDA Webcast here.

Editors Note * There were no injured patients present to add their point of view and perspective to adverse events!

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Dr. Jeffrey Shuren, CDRH

OCTOBER 3, 2011 -  How to speed up the approval of a medical device that cannot claim it is substantially similar to one already on the market under 510(k)? On Friday, September 30, the Food and Drug Administration released a long-awaited proposed revision to the 510(k) clearance process that could speed up product reviews by 90 days.

Under FDA clearance rules, the de novo medical device clearance process, is for those devices that are not substantially equivalent to another legally market medical device and cannot be cleared under 510(k). Once rejected for clearance to market under 510(k), the company then files a de novo petition. But industry considers the process cumbersome as it’s known to delay further the clearance of a medical device for market.

Here is the draft guidance.  The de novo process has been underused said the FDA and could be “improved and greater clarity could be provided regarding suitability and data needed so that the de novo process may be a more viable pathway for novel low to moderate risk devices.”

So here is how it would work. A company wants to market its device. If it is not similar to one on the market, the company would file a pre de novo submission or PDS. The company admits its product is completely novel but reminds the FDA it is low risk. Under the proposal, the FDA would also allow the manufacturer to also file a 510(k) clearance proposal doubling the chance for clearance.

The problem with building upon or expanding the 510(k) approval process is that it has many critics. An Institute of Medicine (IOM) report issued in July called the 510(k) clearance process “fatally flawed” because all sort of devices were being grandfathered in as substantially equivalent even though they may be made of different material, have a different function, and  new technologies and complexities beyond what the original device ever dreamed of.

The IOM suggested scrapping the approval process and starting over.

Another question – How does one define low or moderate risk?  Synthetic surgical mesh is considered a Class II or moderate-risk medical device even though the FDA has issued two warnings questioning its risk over benefit after thousands of patients have been injured.

Legislation passed by Congress in 1997 created the de novo process for devices that could not claim substantial equivalence.

“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement. “Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients.”

What does industry think?

AdvaMed, Advanced Medical Technology Association, the manufacturer’s lobby group says in a statement that it is reviewing the guidance but that the current de novo process takes too long.

Dr. Shuren was a featured speaker at an AdvaMed conference last week.

This is one of the 25 action items the FDA planned earlier this year in promising to make changes to the 510(k) approval process. The public has 90 days to comment. The FDA’s website (here) outlines how you may comment.  #

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SEPTEMBER 8, 2011 –

This was the first of a two-day expert panel to decide the fate of mesh to repair a woman’s pelvic floor was characterized by how little is known about the medical device.

Even with a lack of critical data, an estimated 75,000 surgeries were performed last year using the petroleum-based plastic mesh to repair a common condition known as pelvic organ prolapse or POP.

One hundred new pelvic mesh devices have been approved by the FDA’s Center for Devices and Radiological Health since 2002 with no requirements for scientific studies or clinical trials. At the same time adverse events have increased five- fold. Devastating side effects include mesh eroding through the vaginal wall, infection, pain and a recurrence of prolapse.

Patient Testimony

Mesh injured patient Janet Holt told the FDA panel she had the mesh come through her leg groin. She often cannot walk or sit. “We do not need further studies we have already done trials on women and I am one of them.”

Not all doctors supported mesh wholeheartedly. Dr. Debra Myers of the American Urogynecological Society said they do “not support the routine use of transvaginal mesh for prolapse, but there may be circumstances when it is appropriate.”

Dr. Denise Elser, a specialist in pelvic medicine at the University of Illinois said “Over all we don’t know enough about transvaginal mesh for prolapse repair. We need to balance the risk with the benefits to our patients.”

“Thoughtful placement of surgical mesh should be performed only by trained surgeons “and “should not be widespread” said Edward Varner, president of the Society of Gynecologic Surgeons.

Reclassify Mesh

The key question to be answered during this two-day meeting is whether transvaginal mesh, a Class II medical device should be reclassified as high risk or Class III.

The question was raised following the July 13^th FDA advisory warning complications were “not rare” and that thousands of women had suffered complications. A July 29^th Institute of Medicine report warned that the current process that approves mesh for marketing without safety and efficacy requirements, called 510(k) was “fatally flawed” and the process should be scraped. Under 510 (k) all a manufacturer must do is claim its device is “substantially equivalent” to others already on the market.

Panel members agreed they want more regulation and more guidelines for training doctors. The emergence of precut synthetic mesh “kits” aggressively marketed to doctors who do not regularly perform surgery are though to have added to the complication rate. Also missing from the equation is any formal follow up with patients and a registry of adverse events.

In the meantime injured patients have filed hundreds of lawsuits against leading manufacturers Johnson & Johnson and C. R. Bard Inc.

If mesh is reclassified to Class III Herb Lerner of the FDA told MDND devices currently on the market would stay and the agency would work with industry to be the “least burdensome” solution, allowing for a grace period before tighter post market requirements would take place.

The panel made up of academics, surgeons and patient/consumer reps will advise the FDA on how to proceed. The FDA does not have to follow the advice of its expert panel.  #

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