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Medical Device Division of FDA Broken, Needs Fixing

Posted by Jane Akre
Wednesday, April 22, 2009 4:23 PM EST
Category: Major Medical
Tags: Medical Devices, FDA, Surgical Mesh, 510(k), Defibrillators, Hip Joints,

Medical devices are the focus of intense FDA scrutiny as the bulk are on the market without premarket approval.
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IMAGE SOURCE: iStockphoto/ hip joints

The Food and Drug Administration’s office that oversees medical devices is broken and needs fixing.

That is the overwhelming consensus that has initiated an internal FDA meeting today to decide the direction of the device center, reports the New York Times.

The agency has already asked medical device makers to justify that some of their products, already on the market, are safe.

They include external heart defibrillators, dialysis catheters, hip joints, spinal screws and a heart pump.

Companies such as Medtronic, Royal Philips Electronics, Zoll Medical Corp, Covidien, Zimmer Holdings, Johnson & Johnson, and Abiomed, have all been asked to provide additional proof of safety. The companies may have to pay for additional clinical trials or have them reclassified as less risky.

Internal Dissent

As President Obama was taking office, nine scientists alerted him to the internal problems, accusing the agency of acting illegally by approving devices for sale, even when others objected because of safety issues.

Devices mentioned included imaging equipment for breast cancer and an orthopedic knee device.

Those concerns have now been passed onto the new FDA deputy commissioner Dr. Joshua Sharfstein, pleading for his intervention.

Recent headlines have shown that a large number of medical devices, some implanted in patients, have never been tested for safety and effectiveness, and the agency has approved them for marketing after an exchange of correspondence.

IB News recently reported on the numbers of adverse reports from synthetic mesh used to repair hernias and to treat urinary stress incontinence. Synthetic mesh has not been reviewed for safety as a condition for approval, but as a Class II medical device, can rely on a claim that it is “substantially equivalent” to some other product on the market under the agency’s 510(k) approval process.

Even when that “predicate device” has been removed from the market over safety concerns, as happened in the case of Ethicon's TVT mesh, there is no procedure within the agency to re-review the subsequent devices.

Ironically the gaps in safety review of medical devices come after consumers lost their ability to take medical device makers to court following the Riegel v. Medtronics decision by the U.S. Supreme Court in February, 2008.

GAO Critical Of Agency

At the same time, The General Accounting Office issued a report saying that the FDA has not finished a review of products allowed on the market without a rigorous premarket approval process (PMA).

In 1990, Congress directed the FDA to require safety evidence before a Class III device could be sold, but the agency never finished the job.

By 1994, 149 Class III medical devices still had not had a rigorous review. The FDA has been reviewing and issuing new regulations for all but 27 devices.

It is expected to take several years before the agency is finished with the reclassification process.

Diana Zuckerman, a critic of the FDA and president of the National Research Center for Women & Families, says that of the 5,000 medical devices approved by the FDA’s Center for Devices and Radiological Health (CDRH) last year, 98 percent were cleared through a “quick and easy” process that usually does not require clinical trials to prove that these medical devices are safe or effective. #


5 Comments

Anonymous User
Posted by Suzanne McClain
Thursday, April 23, 2009 12:59 AM EST

The FDA is having a meeting! This is progress, but not the kind of progress we victims, and the thousands of potential victims need.

It is imperative that the FDA suspends the use of all Class II devices that are internally implanted within one's body. Any device that is used as a permanent implant needs to be reclassified to a Class III device and be subject to INDEPENDENT clinical trials!

I was harmed by Ethicon’s Gynecare Tension Free Transvaginal Taping (TVT) System, of which Jane Akre wrote about in her articles "Suffering in Silence from a Medical Device - Surgical Mesh, Part one and Part Two.”

This device was approved under the FDA's 510K approval process, a flawed process by which a manufacturer of a Class II Medical Device only has to show their product is substantially equivalent to another product already on the market to obtain FDA approval. Approval in most cases is granted within 90 days, with no clinical trials being required.

Some Class II devices which fall into this category, are devices that are permanently implanted within one’s body. Surgical mesh used to “treat” hernia and incontinence issues fall into this category, and people are being irrevocably harmed as a result of this lackadaisical approval procedure.

The device by which I was harmed received FDA approval on January 28, 1998, and its approval number is: K974098. This is a polypropylene mesh product and it is petroleum-based. When I had it implanted in 2004, I was not made aware of the most serious complications: erosion of tissues and adherence to organs and/or nerve beds. I also was not told of other procedures where my own biological materials could have been used to correct my problem. Most important, I was not told of the 664 adverse events on file with the FDA on their MAUDE Database at the time immediately prior to my surgery, which would have allowed me to make an informed, educated decision as to whether or not I should proceed with the surgery. To date, there are nearly thirteen hundred (1300) adverse events on file, including my own.

Before my problems arose, I had never even heard of the MAUDE Database, and in conducting a multitude of research, I was able to determine that this database is not maintained in a uniform fashion.

In order to gain approval for the product implanted in me, the manufacturer cited substantial equivalence to the ProteGen Sling (called a predicate device) that was pulled from the market nearly a year later by its own manufacturer via a letter to the Food and Drug Administration on January 22, 1999. They cited complications with a "higher than expected rate of vaginal erosion and dehiscence," and further stated "and does not appear to function as intended."

It angers me that any device approved, using a predicate device as their substantial equivalent, would not too, be pulled from the market upon complications being cited with a said predicate device. The FDA formally recalled the ProteGen Sling on March 17, 1999, nearly two months after receiving the letter from the manufacturer to recall their product. Information regarding this manufacturer initiated recall can be found on the FDA Enforcement Report for March 17, 1999, under Class II Medical Devices.

Despite the fact that the ProteGen Sling was formally recalled, the FDA left on the market other devices that had used this device to gain approval. These products had no business being on the market in the first place. The FDA should never approve a device implanted within one’s body without it being subjected to Premarket approval, and clinical trials. A device that is permanently implanted, should be classified a Class III Medical Device. To maintain the integrity of the approval process, these clinical trials should be handled by an independent entity, not clinical trials overseen by the manufacturers themselves as often happens.

I want people who are considering having a mesh related surgery to be aware of the serious complications that your doctor probably won’t tell you about. It is up to all of us to be aware, believe me, I have been enlightened. Nine months ago, I never would have considered airing my personal business, but in the interest of saving another person from living the nightmare I have lived, I feel it is my duty to speak out regarding this issue.

Please, email me for more information at: aunt_sanner@yahoo.com

Mesh Victims, please consider joining Truth in Medicine, a mesh patient advocacy group committed to getting petroleum based surgical mesh products off the market, and seeing that the FDA receives an overhaul of the 510K Approval Process.

Jane said it is estimated that 2000 pelvic prolapse surgeries are done each month. This is 24,000 potential victims in one years time. This has got to be stopped!

Posted by Jane Akre
Thursday, April 23, 2009 10:05 AM EST

Suzanne-

The problem is so many people are reluctant to be their own advocates when facing their doctor. He/She knows best, right? Unfortunately many doctors are also in the dark about the lack of oversight concerning the very products they are putting into people.

Remember - "First Do No Harm". Only regulation can provide the necessary oversight. These new FDA commissioners have a lot on their plate.

Thanks for your comments and contribution to the public good.

Anonymous User
Posted by JILL PAUL RN
Tuesday, April 28, 2009 12:12 PM EST

Jane, Why would it take the FDA 19 years to act on such an important matter as to requiring safety evidence before a class lll device can be sold? If our Hospital took 19 years to change a method required by JACHO, we would not be accredited and would be out of business. If the FDA had assumed a more responsible position and had done what Congress had asked of them 19 years ago, people like Suzanne McClain and my husband would not have had to suffer the consequences of having a defective medical device implanted. The Medical Device Safety Act needs to be passed by the Congress and The Senate now to prevent more people from suffering due to the lack of FDA regulation.

Posted by Jane Akre
Tuesday, April 28, 2009 12:55 PM EST

Hello Jill-

The only explaination that makes sense is that it is a prime example of the tail wagging the dog.

Industry has the funds to suggest (some would say dictate) to federal agencies what the agenda will be, and unfortunately we sometimes see the ramifications with glaring clarity. Different administrations allow differing amounts of industry influence to take place. The agenda is set at the top and trickles down.

You can be certain that many who go into public health have the public in mind. But the revolving door that is well understood in Washington, provides a second and usually lucrative career for many in government, so not rocking the boat is important.

The poor whistleblowers who try to do good, often get their heads chopped off. Sometimes they are ostracized and lose their jobs, as happened in the case of the federal regulator vet, who tried to alert the FDA about synthetic bovine growth hormone.

To an extent, universities do the same thing when funders come calling. They can direct research and determine outcomes, sometimes at the public expense, in my opinion.

The film, The Corporation, is a good primer on the power corporations enjoy with very little downside that might send an individual to jail. Why does Vioxx and Merck pop into my mind here?)

Thanks for all of your input Jill, we appreciate it.

Anonymous User
Posted by Dave
Saturday, May 02, 2009 11:28 PM EST

I find it difficult to understand how it is not considered criminal that the FDA allows internal devices on the market without proper testing for safety. It also defies any logic that use of a device (like TVT Mesh) was not immediately stopped, when the device it was modeled after was pulled for being unsafe. Instead, its sale and use continued as if it were proven to be safe. I truly admire the scientists who felt approval was unwarranted in many cases and elected to speak out to alert the new Administration. I once thought that the FDA existed to protect the patients, but apparently the leadership of the FDA decided it is more important to benefit the manufacturer. Something is seriously wrong.

Comments for this article are closed.

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