FDA responsible for patient safety: not jobs! NEJM article

http://www.nejm.org/doi/full/10.1056/NEJMp1204170#t=article

Perspective

Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

Saptarshi Basu, M.P.A., and John C. Hassenplug, M.Sc.

N Engl J Med 2012; 367:485-488August 9, 2012

Interview with Dr. Rita Redberg on the approval process for medical devices in the United States and in Europe. (23:44)

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 The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European approval process.1 This contention is often used to support the argument that the Food and Drug Administration (FDA) should lower its standards for approving medical devices, since a slow approval process is delaying Americans' access to innovative and lifesaving technology. But a review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets (Germany, France, Italy, and Britain)2 — largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.

To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.

Second, an accurate comparison of time to market access requires measurement of the total time that elapses between application submission and market access. Previous studies have compared the chronologic dates of application submission and market access, but the date an application is submitted varies from country to country.

Third, patient access should be equated with the availability of reimbursement rather than with device approval, because broad patient access to a new device doesn't occur until reimbursement by a national or third-party payer is available. Previous comparisons of the U.S. and European systems have used the approval date to measure process duration, but innovative, high-risk devices don't reach a market where most patients can benefit from them immediately after gaining regulatory approval, though they may be accessible to patients who can afford to pay out of pocket. Rather, there is a second level of review through which public or private insurers decide whether and at what price they will pay for a device. Generally, public systems take longer than private insurers to make reimbursement decisions, and significantly more Europeans than Americans have public insurance. Two thirds of the U.S. population is covered by private health insurance, whereas only a fifth receives publicly funded reimbursement, primarily administered by the Centers for Medicare and Medicaid Services (CMS).

For both private and public systems in the United States, the pathway to patient access to a device starts with the submission of an application to the FDA. The FDA reviews innovative, high-risk devices for safety and effectiveness (clinical benefit) under the premarket approval (PMA) process, and information on the duration of reviews is publicly available. In fiscal year 2011, the FDA approved 40 applications for PMA. The average review time was 13.1 months, with 8.4 months attributed to FDA review time, and 4.7 months to the time the agency waits for the sponsor to address deficiencies in the application (“sponsor time”).3 CMS provides reimbursement for the majority of devices when they earn FDA approval. For a limited number of devices each year, however, CMS conducts a national coverage determination in response to external requests for validation or for devices that have limited or conflicting evidence of clinical benefit. This process averaged 8.6 months over the past 5 fiscal years.4 Although it is difficult to obtain data on how long private insurers take to make coverage decisions, anecdotal information from private insurers suggests that decisions are made within a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.

In Europe, by contrast, most of the 27 member countries of the European Union (EU) have publicly financed health care systems; such systems cover approximately four fifths of the populations of the four largest device markets. All EU countries require devices to first obtain a Conformité Européenne (CE) marking, which refers to a symbol shown on products that indicates market approval throughout the EU. The CE marking process is conducted by for-profit, third-party “notified bodies” that have been accredited by a member country to assess device safety and performance but do not evaluate effectiveness (which requires more clinical data). Although publicly available data are limited, anecdotal information from notified bodies suggests that the process takes 1 to 3 months, excluding sponsor time.

Most European patients do not have access to innovative, high-risk devices as soon as the devices receive a CE marking. Each country must first make a decision about reimbursement, a process that varies substantially among countries.5 Though a CE marking can be granted on the basis of fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those that the FDA imposes for device approval. European countries may require additional data on the device's safety and effectiveness, as well as on cost-effectiveness.

In France, a centralized body makes reimbursement decisions after assessing the safety and effectiveness of individual devices. Reimbursement decisions in Italy are devolved to the various regions, and Britain and Germany conduct broader assessments of device types or procedures, rather than of individual devices. Typically, innovative devices not covered under an existing diagnosis-related group (DRG) require review under the lengthier Health Technology Assessment process, which assesses safety, clinical benefit, and cost-effectiveness. Government-provided information on time to reimbursement varies by country. Estimated time frames are an average of 71.3 months in Germany, a range of 36.0 to 48.0 months in France, a range of 16.4 to 26.3 months in Italy, and an estimated 18 months in Britain.

Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets (see figure

Missing graphic:  Comparison of Time to Market in Premarket Approval and Reimbursement Processes.

 The public (CMS) process in the United States takes approximately as long as those in Italy and Britain, approximately half as long as that in France, and less than a third as long as that in Germany. The difference in time to market access is even greater when it comes to private insurers (covering the majority of the U.S. population), which often make reimbursement decisions within a few months after FDA approval.

To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see table

Missing graphic: Comparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.

These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.

These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than in another and do not reflect experiences with all innovative, high-risk devices. However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on August 1, 2012, at NEJM.org.

SOURCE INFORMATION

From the Office of Planning, Office of the Commissioner, Food and Drug Administration, White Oak, MD.

'Unaccountable' medical industry: patients would be shocked.

YouTube Video

http://www.youtube.com/watch?v=d9Pi8F-lWuA&feature=plcp

 This 4 minute video trailer brilliantly explains how the medical 'system' currently works as it introduces Dr. Marty Makary's soon-to-be released book: "Unaccountable". 

Failed hips, vaginal mesh, Iap band, FDA system.

LINK  with video included

CONSUMER REPORTS Investigates: Dangerous medical devices

Most medical implants have never been tested for safety

Consumer Reports magazine: May 2012  (FiDA blog bold)

Tens of millions of Americans live with medical devices implanted in their bodies—artificial joints, heart defibrillators, surgical mesh. And it’s a safe bet that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.

But that is rarely the case. For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients—including two of the three people whose stories are told in this report.

As for the smaller number of high-risk products for which advance safety studies are required, government rules allow them to be sold based on studies that are smaller and less rigorous than those required for prescription drugs.

“Standards for devices exist, they just don’t make sense,” says Diana Zuckerman, Ph.D., a vocal critic of the current system and president of the National Research Center for Women & Families, a nonprofit advocacy organization.

In 2011, a panel from the prestigious Institute of Medicine said the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market. Instead, Congress is now debating a new law that would keep the present system virtually intact and ratify an agreement between the FDA and industry to get devices on the market even faster.

The FDA believes “the program has served American patients well,” says Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health. “As a responsible guardian of public health, the FDA believes it’s a challenge to eliminate a program without having a better alternative.”

But an investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:

•                 Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.

•                There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”

•                Without major changes in the system, there’s not much that patients can do to protect themselves.

Below are stories from three people, injured by three very different devices, that highlight the dangers consumers face in the current marketplace.

Surgical mesh: No testing

Janet Holt was “in such pain I couldn’t sit, I couldn’t stand, and I could hardly walk.”

Photo by: Alexander Aleman

In 2007, Janet Holt of Floresville, Texas, felt swelling in her pelvic area. She went to her gynecologist, who told her that her bladder and uterus had prolapsed—dropped out of their normal position within her pelvis. The doctor recommended a hysterectomy and bladder lift.

“He talked about building a little bird’s nest to hold my bladder up,” Holt recalls. “He said I’d be back at work in two weeks.” She has yet to return to work full-time on the cattle ranch and small chain of restaurants she runs with her husband.

The “bird’s nest” turned out to be a sheet of synthetic mesh that was implanted by instruments inserted through the walls of her vagina. In the weeks and months after surgery, she says, “I was in such pain I couldn’t sit, I couldn’t stand, and I could hardly walk.” Over time, the mesh shrank and shifted, eventually working its way back out of the vaginal wall, an experience Holt likens to “open cigarette burns with each step you take. It’s complete torture.”

Today, after eight surgeries to adjust and remove the mesh, Holt, who is suing the device manufacturer, says she has been left with painful nerve damage in one leg. “I’m 54 years old and it has totally ruined my life,” she says.

Holt is one of hundreds of thousands of women implanted with transvaginal mesh for prolapse repair and bladder support since the first such products came on the market in the early 2000s. Manufacturers marketed the mesh packaged in a “kit” with tools for insertion and marketed them to doctors as an easier way to do a surgery that had traditionally required special additional training.

“The companies were saying, ‘The salesman will show you how to do it,’ ” said Lewis Wall, M.D., professor of obstetrics and gynecology at Washington University in St. Louis. Despite thousands of reports of adverse events, repeated alarms by women’s-health and consumer-health advocates, and multiple lawsuits, these products are still being sold—and are still classified as “moderate risk” devices.

In an August 2011 petition asking the FDA to take transvaginal mesh off the market, the consumer advocacy group Public Citizen called it “a ‘poster-child’ example of the fundamental failure ... to protect the public’s health and welfare.”

How did it happen? The mesh manufacturers took advantage of a loophole in the law that allowed them to grandfather their products onto the market without any advance safety testing.

Related Topics

Here’s how it works: Before 1976, a manufacturer could sell virtually any medical device at will. That year, a new law for the first time classified medical devices into three risk categories, with clinical data required only for devices in the highest-risk category, Class III.

The FDA has yet to fully enforce even that minimal testing requirement. The agency routinely clears new devices in all three risk classes without clinical testing as long as manufacturers can show they are “substantially equivalent” to a device that has already been on the market.

And that’s exactly what the makers of transvaginal mesh did. The mesh kits were cleared based on their “substantial equivalence” to an earlier mesh used to repair abdominal hernias that was sold as long ago as the 1950s, even though the kits were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.

“You’re putting a foreign object into the pelvis through a contaminated space, so there’s a very high potential risk of infection,” Wall says. “But there weren’t any clinical trials done with these products before they hit the market.”

“The paradox is that companies go to the FDA and claim that a device is ‘substantially equivalent,’ but when they market it, they claim it’s ‘new and better,’ ” says Rita Redberg, M.D., a professor of medicine at the University of California, San Francisco, and editor of the Archives of Internal Medicine. The clearance process costs manufacturers next to nothing; they pay the FDA a user fee of $4,049.

It was only in January 2012, about 10 years after the first kits hit the market, that the FDA took action. It ordered 33 companies to conduct the first-ever post-market safety studies of the products. The agency is thinking of reclassifying those mesh kits to the highest-risk Class III.

But Shuren, at the FDA, notes that with the government’s rule-making process, “from the time the FDA decides to upclassify a device to the time it can actually do it can take years.”

Lap-Band: Minimal testing

Lisa Wilson's weight-loss device had to be removed after it cut into her stomach.

Photo by: Inti St. Clair

In 2009, after many unsuccessful diets, Lisa Wilson, then 46, a pharmacy technician from Seattle, received the Lap-Band adjustable gastric band.

The implanted band constricts the size of the stomach to make it difficult to eat large quantities of food. In fact, the opening left to Wilson’s stomach was so small that she had difficulty eating even small amounts of food. It also caused her to throw up almost every day.

But she stuck with it, losing 70 pounds, until a routine endoscopy in December 2010 revealed that the band had cut into her stomach lining and would have to be removed immediately. She developed a post-surgical infection that resulted in a partially collapsed lung and an eight-day hospital stay. Wilson says she has regained half of the weight she lost.

More than 650,000 Lap-Bands have been sold worldwide, according to the 2010 annual report from its manufacturer, Allergan. It’s among the minority of devices so novel that manufacturers can’t find an older product for grandfathering.

Those products usually have to undergo advance testing for safety and effectiveness to get the FDA’s approval for marketing. But the tests aren’t nearly as rigorous as those required for prescription drugs, even though, as Redberg notes, “if you have a problem with a drug, you can just stop taking it, but you can’t do that for a device implanted in your body.”

And the FDA charges device manufacturers only $220,050 to review a new device, compared with the $1.84 million it charges to review a new drug application.

If Lisa Wilson had seen the lone study on which the approval was based, she might not have been surprised by her problems. Of the 299 people in the study, 51 percent reported nausea, vomiting, or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure to lose enough weight.

“Imagine if a car had a recall rate that high,” says John Santa, M.D., director of the Consumer Reports Health Ratings Center. “Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden.”

The Lap-Band clinical trial was fairly typical of such pre-marketing studies. Redberg and colleagues looked at 123 studies done on high-risk cardiovascular devices that received FDA approval between 2000 and 2007. Only 27 percent met the gold standard of being randomized clinical trials, according to the report, published in December 2009 in the Journal of the American Medical Association.

Metal hips: Missed alarms

Stephen Tower, M.D., was injured by the same artificial hip he implanted in patients.

Photo by: Clark James Mishler

If any patient should have gone into a hip replacement fully informed, it was Stephen Tower, M.D., 55, an orthopedic surgeon from Anchorage, Alaska. Instead, he became the victim of another device that was grandfathered onto the market without clinical testing.

In this case, it was an artificial hip introduced in 2005 by DePuy, the orthopedic division of Johnson & Johnson. Called the ASR XL (shown at the top of this page), it was distinctive because both components—the ball at the top of the femur and the socket liner inside the pelvis—were made of chrome-cobalt metal.

The FDA cleared it without clinical testing based on “substantial equivalence” to earlier devices, though such metal-on-metal hips had long been on the agency’s high-priority list for requiring advance clinical trials.

The all-metal hips were supposedly a great advance over hips with the traditional plastic socket liner, Tower recalls. “The main reason hips traditionally failed was because of plastic wear,” he says. “The metal-on-metal hip was being promoted not only commercially but in the medical literature as being a solution for patients like me, who wanted to return to no-holds-barred physical activity.”

By 2006, Tower’s arthritic hip had forced him to give up practically all the outdoor pursuits he had moved to Alaska to enjoy. He had a DePuy ASR XL implanted in May of that year, and “within six weeks I did a double century bike race,” he says. He was so enthusiastic that within 10 months he had put various models of metal-on-metal hips in six of his patients.

But by the time a year had passed, it became clear that something was wrong. His hip was “pretty much constantly painful” and the chromium and cobalt levels in his blood “were notably high,” he says. Then he started noticing other problems, such as disturbed sleep, mood swings and anxiety, hearing loss, visual problems, and tinnitus.

Throughout that period, he says, he repeatedly questioned DePuy engineers, design surgeons, and sales representatives, “and they’d say, ‘Geez, Steve, we haven’t heard of this.’ ”

Tower’s symptoms became so severe at times that he was unable to work. Meanwhile, his research, some of which he has since published in medical journals, was uncovering evidence that metal debris from joint implants can cause what he describes as “profound poisoning.”

After having the hip removed in 2009 and replaced with a new one made of ceramic and plastic, his symptoms have markedly improved.

In August of 2010, DePuy recalled all 93,000 ASR XL hips worldwide after it became clear that the device was failing far more often than average and producing serious injuries. While it’s unclear how many people actually have had to have their artificial hip removed, an article in the British Medical Journal called it “one of the biggest disasters in orthopaedic history.”

Although the hip was invented and manufactured by an American company, the recall occurred because as early as three years previously—even as DePuy’s engineers were assuring Tower that the hip had no problems—regulators in Australia, England, and Wales were noticing serious problems.

They were able to do so because they have national joint registries—a list of every joint implanted—and the ability to track how patients fare with various models. There is no such national registry in the U.S., although Kaiser Permanente has a large private one.

The FDA has a voluntary system whereby doctors, manufacturers, and patients can report problems with medical devices. And though experts estimate that only a fraction of device problems ever get reported, from 2009 through 2011, the agency received 20,518 reports of injuries from metal-on-metal total hip replacements. Of those, 15,137 concerned the now recalled DePuy hip. Many of the remaining complaints concerned several other brands and models that are still on the market in the U.S.

The 2011 Institute of Medicine panel concluded that the FDA’s ability to spot problems is so inadequate that it’s “impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market.”

How to fix the system

Consumers Union, the advocacy arm of Consumer Reports, agrees with the Institute of Medicine that the current system of medical-device regulation doesn’t protect patients from harm. Consumers Union recommends that the FDA:

•                 Require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.

•                End the practice of “grandfathering” high-risk new implants and life-sustaining devices.

•                Create a “unique identifier system,” or IDs for implants, so that patients can be quickly notified about recalls and safety problems.

•                Create national registries so that problems can be spotted quickly and patients notified.

•                Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.

Have you had a problem? Tell us about it now. If you’ve had a problem with an implant or a medical device, please tell Consumer Reports about your experience. Your information is kept confidential (unless you indicate otherwise) and your story helps us monitor medical problems, research future articles, and push for reform.

To help, go to SafePatientProject.org and click on “Share Your Story” or click on “Act Now” to help us work for change.

Protect yourself against risks

Here are a few steps you can take to guard against the risks posed by dangerous medical devices.

Consider alternatives. Ask your doctor what will happen if you don’t get the implant. Many women who received transvaginal mesh for prolapse repair, for example, probably never even needed surgery.

“Pelvic organ prolapse is almost never a life-threatening condition. It’s a quality-of- life issue,” explains Daniel S. Elliott, M.D., assistant professor of urology at the Mayo Clinic College of Medicine. “The overwhelming majority of women do not need to have surgery. If you’re not bothered by it, then don’t do anything. I think many patients weren’t adequately informed about that.”

You may also have non-mesh alternatives. Elliott says he and other well-trained pelvic surgeons routinely repair prolapses with techniques that don’t require any mesh at all. On the other hand, people ill enough to need an implantable defibrillator for their heart may not have another choice.

Research the device. The Food and Drug Administration’s website, FDA.gov, has a wealth of information about device safety warnings, complaints, and recalls, easily accessible by typing the name of the device into the site’s search box. It’s also worth searching Google. If the results include a lot of law firms looking for clients injured by the device, that’s a sign to ask your doctor some hard questions.

For an optional device like a Lap-Band or breast implant, look around the Internet for patient forums. Though the information there isn’t validated, you’ll get a sense of whether patients are reporting trouble with the device.

Write down what you got. If your doctor doesn’t give you information about the brand name, model, and serial number (if it exists) of your device, ask for it. If you learn of a warning or safety recall, from the FDA or elsewhere, you’ll know whether yours is one of the problem models.

Stay alert—but don’t panic. If you learn that there are problems with your device, contact your doctor and ask what warning signs to watch for. Also go to the FDA website to read up on official warnings and find out whether it’s safe to keep the device in your body.

For example, if you have a metal-on-metal hip, call your doctor if you have pain or other unusual new symptoms, such as heart, vision, hearing, emotional, or neurological problems, because all of those might be signs of a reaction to the device. You might also want to get your blood tested for high cobalt levels, a sign that the hip is deteriorating.

But don’t assume that all problematic devices have to be removed. For example, pelvic surgeons say they often get calls from worried women who have had mesh repairs. “If the mesh is not causing any problem, don’t do anything because getting mesh out is very difficult and dangerous,” Elliott says.

Cardiac devices are risky, too

Automatic external defibrillators have been recalled 90 times in seven years.

Cardiac devices dominate the list of reports to the Food and Drug Administration of deaths and injuries. Here are three devices that have had significant problems in recent years:

Implantable cardioverter-defibrillators. Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to our analysis of the FDA’s database of adverse events. Implanted in more than a half-million Americans with serious heart disorders, the defibrillators detect abnormal rhythms and administer shocks to correct them.

The most troublesome aspect of the devices are the leads—wires that connect them to the heart. There have been two major recalls, in 2007 and 2011, of defective leads, the Medtronic Sprint Fidelis and the St. Jude Riata, after they had already been implanted in almost 350,000 patients. Patients with the device leads require close monitoring and face the prospect of having to have them surgically removed.

In congressional testimony in 2009, Boston cardiologist William Maisel, M.D., described what happened to a patient of his: “The simple act of removing his shirt over his head caused his … lead to fracture. [He] suffered a cardiac arrest in front of his wife.” The patient survived but never fully recovered.

Vena cava filters. These devices are placed in the vessel that returns blood from the lower body to the heart to prevent pulmonary embolism, a life-threatening condition caused by blood clots breaking loose from the leg and traveling to the lungs. Some 200,000 people get such filters each year.

Many should be removed once the danger of clots has passed, but often aren’t. In a November 2010 study in the Archives of Internal Medicine, Pennsylvania researchers found that pieces of the Bard Recovery filter had broken off and migrated elsewhere in the body in one of four study patients. One patient needed open-heart surgery.

“Remarkably,” wrote cardiologist Rita Redberg, M.D., of the University of California, San Francisco, in an editorial accompanying the report, these filters “were considered Class II by the FDA—the same risk category of mercury thermometers—and received approval without any clinical data of safety and effectiveness.”

“The devices were being used inconsistent with their FDA clearance,” says Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health. “We don’t have authority to do something about that.” If you’ve received the device, ask your doctor whether it has been removed.

Automated external defibrillators. Found in airports and other public buildings, these devices are designed so that bystanders can operate them. AEDs automatically diagnose abnormal heart rhythms and deliver shocks to people in cardiac arrest.

The problem is, they don’t always work. The industry has conducted about 90 recalls over the past several years, affecting hundreds of thousands of devices. Between 2009 and 2011, the FDA received reports of 72 injuries, 686 deaths, and 20,667 malfunctions connected with the devices. Arizona researchers found that in most cases the machines weren’t able to diagnose the abnormal rhythms properly or failed to deliver the recommended shock.

The FDA is considering whether to downgrade AEDs from the highest-risk category to moderate-risk. recalled Defibrillators have been recalled 90 times in seven years.

Editor's Note: A version of this article appeared in the May 2012 issue of Consumer Reports magazine with the headline "Dang

Patient Harm From Implanted Surgical Mesh

KGET news Couple Wins Landmark Trial Against Implanted Surgical Mesh Company.

Open letter to Surgeons who have implanted mesh

:

Each of you who blatantly disregarded your patients pain and suffering has broken the oath, “First, Do NO Harm.” You have harmed us many times over. And will continue to do so until you take the time to educate yourselves beyond what a pharmaceutical representative tells you.



What, exactly, did you KNOW about mesh before you advised your patient? Did you KNOW that is supposed to be permanent? Did you KNOW that mesh might not work well for everyone? Did you KNOW that mesh was inert, or that it wasn’t? Did you KNOW if mesh could shrink, curl and damage surrounding tissue as it moved? Did you KNOW if the patient would have a foreign body response to the mesh? Did you KNOW that a bad reaction might cause repeated infections and or bleeding? Did you KNOW what the possible complications were associated with blind insertion of mesh? Did you KNOW if the one-size-fits-all kits would work on every one the same, regardless of body type or size? Did you KNOW that nerve entrapment or injury was probable? Did you KNOW that if an adverse reaction to mesh occurred that the only way to alleviate the symptoms was to remove the mesh? Did you KNOW that the resulting pain of nerve injury and or reaction to the mesh would cause your patient to LOSE quality of life? Did you KNOW how many of your patients might die due to complications arising from mesh implantation? Did YOU know?

 If you didn’t you should have. If you did, you forgot to mention this to us. 

Failing to tell us any of that, how could you belittle us when we begged for help? Is there something written somewhere that this is due course when a patient comes to you for medical assistance? We came to you, as a person of trust, to help us find answers to why we were left in this horrible condition after an operation you claimed would lift our quality of life.

Instead of answers we had pieces of eroding mesh yanked and cut from our most private parts without any numbing agents. Then we were sent to pain clinics where we were given painful shots in our abdomens and sensitive pelvic areas, that gave little to no relief, and pelvic physical therapists who caused more pain. And when these actions didn’t alleviate our symptoms we asked if the mesh was the cause. Our question was not appreciated which resulted in our being disrespected, treated to eye rolls and told it was all in our head. In some cases you walked out on us, told us to leave or were physically and or verbally abusive. Yet many of us continued to believe in you even though, in our hearts, we knew different and have suffered needlessly because of it. 



Many, if not all of us, have been told we were the “only” patient who ever had problems. How can hundreds, thousands, tens of thousands (the total numbers are unknown) of people each be the ONLY one who has had adverse reactions to mesh? How many complications were you aware of but didn’t bother to mention because you were told they were rare and this was the GOLD STANDARD of treatment for POP, SUI and Hernia repair?

If you are finding many more patients than usual do not trust your advice it is because you have forced us to look beyond you, to look for answers you are either unwilling or unable to give. 

YOU are the doctor, the one who is supposed to know the medical answers and if you don’t then it is your job to find them.

It is not the patients responsibility to determine whether a product or drug is in their best interest, to know what is safe. That is YOUR responsibility, why you get paid the big bucks! Just because a representative of a pharmaceutical company says it’s so, doesn’t make it so. And just because the FDA has cleared a product through the 510(k) doesn’t mean that it’s safe for patient use. It’s time to go back to treating patients as human beings instead of quotas on the insurance gravy train .  

  .  and if you can’t or won’t then maybe it’s time for a new career.

 Jaye Lee       

Regina Holliday keynotes in Australia!

A 'patient harm' advocate keynotes in Australia!

Regina Holliday is a young mother of two sons who is tirelessly working to make sure that all patients have access to their medical record.  Her husband's death was fraught with medical missteps and gaffs that were hurtful and altogether preventable.  It is her mission that these health system errors are corrected.

She is now in Sydney, Australia to keynote the Health Informatics Conference.

While she is working for us, let us overwhelm her with donations to her favorite causes!


Provide travel/conference cost support for patients and their advocates.
Please purchase her new book  The Walking Wall: 73 Cents to The Walking Gallery
Partnership With Patients in Kansas City, MO September 21-23, 2012

FDA Webcast Videos: Harmed Patients Testify

http://fda.yorkcast.com/webcast/Viewer/?peid=12f84ea095b445d78e9b115f495392731d

Metal on metal hips have harmed thousands.  June 27and 28, 2012, FDA allowed each harmed patient just 4 minutes to testify.  Patients paid for their own flights/hotels/meals.  Testimony begins at 1:34 (one hour, 34 minutes).  The meeting was nearly 20 hours over two days.  On this second video, at the end, you will see two women who are the FDA Patient Representative (Barbara Berney) and the FDA Consumer Representative (Connie Whittington) who are paid and hand selected by FDA to represent our interests.
http://fda.yorkcast.com/webcast/Viewer/?peid=901726ab91944b158ac705e48664921c1d

It is instructive to confirm that the realization of harm came from foreign countries that had registries!  Medical device companies continued to market devices for years though there was evidence of their harm and ineffectiveness.  FDA was late in stepping in.

Generic Orthopedic Implants?

LINK

'Generic' medical devices could cut into name-brand profits

By David Sell  The PhiladelphiaInquirer        July 23, 2012 - 3:11 pm EDT  (FiDA bold)

PHILADELPHIA — Generic competition — a billion-dollar problem for brand-name drug companies since the 1980s — is making inroads in the orthopedic medical devices industry. Last week Cardinal Health Inc., one of the three biggest device wholesalers, said it was increasing its offering of lower-cost products for broken bones.

This nascent trend, borne of increasing pressure to control health care costs, represents a direct threat to brand-name device makers such as West Chester, Pa.-based Synthes, which was bought in June by Johnson & Johnson for $19.7 billion.

Cardinal Health, 21st on the Fortune 500 list, is based in Dublin, Ohio. In announcing its so-called “Orthopedic Solutions” option for hospitals and surgery centers, Cardinal said it could supply some products at 30 to 50 percent savings.

“Based upon our market and customer research, we believe that U.S. health care providers are ready to support a simpler, more transparent, fair priced orthopedic business model,” Cardinal Health executive Lisa Ashby said in a statement.

Cardinal Health entered a partnership with Emerge Medical, a Denver-based company that makes surgical screws, drill bits and guide wires. Emerge CEO John Marotta is a former Synthes sale representative. Synthes was sufficiently annoyed with his efforts that it sued him in 2011. He has countersued, and a trial is pending.

“Together we will provide a low-cost trauma solution that will drive simplicity and transparency to this pressured health care environment,” Marotta said of the Cardinal Health partnership.

The U.S. Food and Drug Administration does not use the term “generic” devices, as it does with drugs, but there is an approval process. Like drugs, medical devices have patents, and the disputes employ numerous lawyers.

Johnson & Johnson CEO Alex Gorsky said last week that medical devices are a $40 billion market worldwide. But Johnson & Johnson, like other device makers is being pressed to lower prices or at least slow the rate of growth.

Trade publication Orthopedic Network News reported that list prices for hip and knee implants increased 4.2 percent between 2011 and 2012 — the lowest increase in the 19 years it has surveyed device manufacturers and the fourth straight decline in the growth rate.

Laura Ruth, director of the health care practice for research and consulting firm Fuld & Co., said the generic device market is still “fragmented,” but pointed to a January report by the Government Accountability Office as an example of greater scrutiny of the cost and acquisition process of hospitals, whose bill are often transferred to taxpayers. Hospitals often buy through group purchasing organizations, which have been criticized for being too cozy with manufacturers and too secretive with hospitals.

The title of the GAO report was: “Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices.”

Because of those forces, Ruth said, “there should be a greater opportunity for lower-cost devices.”