Investigations into Johnson & Johnson's marketing practice - the ongoing saga of unregulated medical devices

One thing has led to another as the US Department of Justice launched an investigation into the marketing practices of the large medical device manufacturer Johnson & Johnson. At the heart of it is the number of recalled hip replacement products since 2010. Gigamole has blogged about this before.

Do not for one moment believe this will put a dent into J&J's marketing strategies. The company is no stranger to these financial penalties. It, like many other companies, have considerable sums of money set aside to cater for these penalties. After all these, Gigamole is sure the company will still be in the black. Two years ago, J&J was forced to pay off US$78 million for having paid bribes and kickbacks. Apparently bribing orthopaedic surgeons is a common practice among device manufacturers. In a report in the Archives of Medicine in 2011, the authors reported on 5 device manufacturers (Zimmer, DePuy Orthopaedics, Biomet, Smith & Nephew and Stryker) who had paid out, in 2007 alone, US$198 million to 939 orthopaedic surgeons.

Which is why medical devices need to be regulated. HSA is being very unwise in leaving medical devices unregulated, because in so doing, they are leaving the patient-consumer at the mercy of the device manufacturers. It is foolish and naive to believe that industry have anything else on their agenda than to generate profit for their shareholders.

To date however, the problems of the recalled De Puy hip replacement devices in Singapore remain unresolved. The HSA appears unwilling to take a strong public position about this. And patient-consumers remain unprotected.

Gigamole wonders when HSA is going to do the right thing?

Depuy hits the headlines in Singapore - finally!

Straits Times Health Correspondent Salma Khalik finally decided the Depuy hip implant problem was important enough to highlight. A half-page spread today.... whoohoo....! Gigamole had been beating this gong for the last 6 months and wondering if anyone was listening. So....thank you Ms Khalik!

Truth is HSA has floundering somewhat with respect to medical devices regulation. With all good intention, it started to do something about it but mismanaged the implementation. After an hysterical outcry from suppliers and practitioners, it pulled back from doing the right thing. Kinda like 3 steps forward and 2.9 steps back.

The Depuy hip implant failure is now subject of a national class action lawsuit in the USA. Just a few days ago, Johnson & Johnson agreed to settle in Australia for A$30,000 per patient. In Singapore however, the situation is far from clear.

There are many problems.
a] Lack of patient awareness. A dear doctor letter was sent out, but there has been no follow up by any responsible party.
b] No one has any idea who received the implant. There is no registry of such implant use.

c] HSA has no idea who is affected, and what to do about it. Gigamole thinks they have just been hoping the problem will fade away in time.
d] There is no service laboratory in Singapore that will measure chromium and cobalt for toxicity.

There is no equivalent of a lemon law for medical devices in Singapore, and no patient consumer movement to look into the interests of the patient-consumer. Like it or not, the only authority who can do this is the HSA, but they seem clueless and toothless.

How about a Lemon Law for medical devices?

Gigamole was delighted to read about the Lemon Law for Singapore. Kicks in today! Gigamole wonders why it had taken so long to want to protect consumers, but ne'er mind, better later than never.

Gigamole also wonders how the Lemon Law might protect the patient consumers from faulty medical devices such as heart stents, and other prostheses. It would seem that that the prostheses itself should be covered under the current Lemon Law, since the patient did "purchase" a device. The surgery to implant the device is not covered, as it would be a "service". On the other hand, the surgeon would actually be the retailer of the device, so should be responsible for the replacement of the device if it were faulty within 6 months.

The problem with medical devices is that defects often do not reveal themselves within 6 months. So the patient often has to shoulder the burden of proving that the defect did not live up to expectations of quality.

This raises a further question of who actually provides assurance of quality of the product and who protects the patient consumer from exploitation by manufacturers. One may expect that the HSA, as the government regulator to provide assurances that any device entering the market has an acceptable level of quality and safety. But this is not the case at the moment. The nascent attempts to regulate medical devices ran into bad publicity, and the HSA has since appeared to shrink from doing the right thing.

So now no one knows if the medical devices that are stuck into a patient's body is of acceptable quality and safety. No one knows who is actually protecting the patient consumer. Recently Gigamole has flagged up issues with metal on metal hip implants, transvaginal meshes, cardiac stimulators, heart valves, which have increasingly been cited in various regulatory withdrawals and law suits overseas. But locally, there has only been a deathly silence from the HSA. So no one apparently wants to inform the patient consumer the bad news. No one wants to point the finger at surgeons for retailing faulty devices. Seems to be that the patient's only recourse is through litigation. Even so,  there should be adequate awareness among patient-consumers that there is a problem. Sadly, there is so little local information available for the patient-consumer to use. HSA's silence is certainly not helpful.

Gigamole believes we need a Lemon Law for medical devices. But not just a law,  we need a healthy consumer protection movement for drugs and medical devices.

Smith & Nephew R3 recall - MHRA advisory

Here's a follow up of the Smith & Nephew R3 acetabular system that Gigamole had highlighted a while back. The UK regulators, MHRA (Medicines and Healthcare products Regulatory Agency) has now issued an advisory about the recall. Their advice is pretty similar to the FDA advisory for the DePuy ASR implant recall.

All patients, symptomatic or not, should undergo MRI or ultrasound scanning. They should be followed for the lifetime of the implant in the body. Blood levels should be checked for cobalt and chromium levels. If either scans are abnormal, or metal levels are rising, surgical revision should be considered.

HSA meanwhile is maintaining their wall of silence.

Latest medical device alert about the DePuy ASR hip replacement recall! Please tell your friends and relatives who have had any hip replacements done.

Gigamole had posted on the DePuy ASR hip implant before. Here is an alert issued from the UK Regulators (MHRA - Medicines and Healthcare products Regulatory Agency) just yesterday.

The United Kingdom with Australia are the two regulatory agencies who have tracked this problem, and had been responsible for flagging up the very high rates of surgical revisions for patients who have been implanted  with these prostheses. In 2010, the UK reported revision rates of about 12-13%, compared to usual revision rates of about 1-3%. This prompted DePuy to implement a global recall of the implants. In Singapore, the HSA reported that there were only 319 implants done, with only 1 revision. One must seriously doubt this figure because HSA does not regulate such medical devices and do not have any kind of tracking process in place, so the revision rates they report are only what surgeons and DePuy want to tell them about. One revision in 319 is an amazingly unbelievable success rate by any standards, so clearly the surgeons are not telling anyone about their surgical failures and the need for surgical revisions.

The HSA has generally left it to the company DePuy and the surgeons to muddle through by themselves, thereby leaving the patients entirely at the mercy of those responsible for this mess.

In any case, the MHRA has deemed it important enough to issue another alert, this one just coming off the press yesterday. You can look through the alert yourself, and if you don't understand the technical aspects, you can just email me and I will try and explain to you.

All patients who have had hip replacements done should get their surgeons to give them the details of surgery and the type of implant that was used.

To summarize, the MHRA recommends that all patients having these Depuy ASR implants, whether symptomatic or not, to undergo an MRI or ultrasound scan. If the images are abnormal, surgical revision should be considered.

All patients should have their blood analysed for chromium and cobalt levels. If the levels are high and rising, surgical revision should be considered. Patient follow-up should be for as long as the implant is in the body.

Obviously these costs should not be borne by the patient.

It is very unlikely that surgeons are either able or willing to recall all their patients who have had such implants done, so many patients will not be aware of the need for follow up or for implants to be removed.  And HSA isn't really doing very much about this. So please feel free to circulate this information to friends or family members who have had hip replacements done. At the very least, they should get the relevant details from their orthopaedic surgeons.

More tales from the crypt - Don't mess with the mesh!

Lest people think I am somehow targeting my orthopod colleagues in sharing about failed and faulty hips, here is a story from a different part of the body.

Johnson & Johnson's Ethicon subsidiary has very recently been involved in a voluntary recall (called by the company, a "discontinuation") of a series of their products -the Gynecare vaginal meshes. These include -the GYNECARE TVT SECUR™ system, GYNECARE PROSIMA™Pelvic Floor Repair System, GYNECARE PROLIFT™ Pelvic Floor Repair System, and GYNECARE PROLIFT+M™ Pelvic Floor Repair System. These are meshes which are being used in women for the repair of urinary incontinence and droopy pelvic floors. The problem was that these meshes were associated with frequent and severe problems such as - pain, infection, bleeding and painful intercourse.

The story leading up to these recalls is a fascinating study of why medical devices should be better regulated.

• Boston Scientific was the first to introduce the vaginal mesh (essentially a modification of a mesh used for repair of hernias) in 1996. 
• Two years later a few companies, including J&J, got approval under the "similarity" regulatory loophole to market similar meshes. 
• The very next year, Boston Scientific recalled their mesh due to safety reasons. Despite this, the other meshes continued selling into the market. 
• In 2005, J&J sneaked through a number of other meshes without even telling the FDA. The FDA only found out about this in 2007, when J&J tried to get approval for another mesh through the 510(k) loophole. 
• This was regularized in 2008 when the FDA approved all the meshes, but without any clinical data being provided.

Very soon after that, problems began to surface, and the FDA in 2008 issued a warning that adverse events were serious but rare. By 2011, a lot of stuff had already accumulated on the fan. The FDA upgraded meshes to high risk devices, and issued a warning that adverse events were not only serious, they were not rare! In addition they wanted more clinical studies if the meshes were intended to remain in the market.

Two weeks ago, J&J informed that instead of doing more clinical studies, they were 'discontinuing' the meshes from the market. The earlier mesh would remain in the market but with modified warning labels.

In the midst of all this, the situation in Singapore, is as usual, business as usual. These meshes, despite the warnings by FDA have continued to be offered as primary solutions in all our major hospitals - KKH, SGH, NUH. There is no evidence that the 'discontinuation' of the meshes by J&J/Ethicon have been implemented here. HSA has been deathly silent. I am not even sure they have been tracking the problem. A search on their website reveals nothing.

The FDA had made a number of recommendations about the use of these meshes (not just the J&J/Ethicon ones):

For health care providers:
• Recognize that in most cases, Pelvic Organ Prolapse (POP) can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

For patients:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

So, some more questions for our HSA, :
Why haven't we done anything about these meshes, since the earliest problems with respect to the Boston Scientific product got recalled; since the first FDA warning in 2008; and the second warning in 2011?

Are these meshes regulated in any way in Singapore?

Is our practice with respect to the use of these meshes consistent with the FDA recommendations above? How do we know?

What is the legal recourse for patients who have been 'misguided' by J&J/Ethicon?

Another medical device bites the dust - the Smith & Nephew R3 acetabular system

Here we go again. Now it's the Smith & Nephew Acetabular System, being voluntarily recalled by the manufacturer, Smith & Nephew Surgical Pty Ltd. Here is an announcement carried through the Australian Therapeutic Goods Administration (TGA). In 2010, the company had actually been issued a warning letter by the FDA about non-compliance with Good Manufacturing Practice. Doesn't this sound similar to the recent mess about the DePuy hip implant recall?

Well, now they finally have to issue a voluntary recall of the hip implant prosthesis, after unusually high failures recorded in Australia and UK. Launched in 2007, apparently about 7700 of these metal liners have been used globally. There is no record of how many of these metal upon metal implants have been used in Singapore itself. To date, it is uncertain how this recall is being implemented in Singapore. One of the recognized problems with metal on metal implants is the potential for erosion and resultant cobalt and chromium poisoning. The recommendation now is for patients who have had such implants to be subjected to life-long screening for toxicity.

So more questions for the HSA:

a] Do we know how many of these implants have been used in Singapore?
b] Do we have a record of patients who have received these implants, and are there processes in place to recall these patients for observation and toxicological screening?
c] How is this being tracked? How are patients expected to know?
d] Why is there no public dissemination of this information? Is this recall being implemented at all in Singapore?

More loopy unregulated medical devices horror stories - the Myxo annuloplasty ring

Gigamole had posted previously on the Edwards SAPIEN heart valve operation recently carried out at the National Heart Centre. It seems that the Edwards Lifesciences company has been getting into all kinds of problems recently also with respect to their Myxo annuloplasty ring. (Online references at the end of this post)

Essentially, the problem was triggered by the complaints from one patient at the Northwestern University research hospital, who claimed that the valve that was inserted into her heart in 2006 was not a FDA approved device, and she was not made aware that it was an experimental option. Furthermore, the surgeon who operated on her was an inventor of the valve and also received royalties from the marketing of the device. The fallout from her complaints have been significant and protracted. Although the university has denied any wrong doing, the patient's position has been supported by another of her doctors at Northwestern.

The background information, very simply outlined here, about this saga, are as follows:
a] In 2001, the FDA apparently rubber-stamped the industry's petition to reclassify heart valve annuloplasty rings to a lower risk category so that it can qualify for the 510(k) regulatory loophole. This meant that the industry can avoid doing clinical trials of an innovation if it can be shown to be insignificantly different from an earlier invention. Edwards Lifesciences used this loophole to launch their Myxo annuloplasty rings, even though they had filed for patents documenting significant differences from older versions.
b] Consequently, at the time the patient received the implant, the FDA did not even know of its existence. The FDA says it therefore never gave any approval. If it is an unapproved device, it should be regarded as an experimental device. The company and the university says it is not experimental, and that it did not require FDA approval under the 510(k) loophole. Meanwhile the surgeon has published the data as part of a clinical study.

The controversy continues to brew and has provoked cries for the FDA to review its approval procedures for medical devices.

Further readings here:
http://www.theheart.org/article/1230079.dohttp://www.theheart.org/article/960385.do http://articles.chicagotribune.com/2011-05-22/health/ct-met-medical-devices-20110521_1_annuloplasty-rings-faulty-heart-valve-diana-zuckerman
http://online.wsj.com/article/SB126151643854401921.html http://www.medicaldevicestoday.com/2009/07/medical-device-fda-510k-policy-modifications-faces-mounting-scrutiny-.html

What have all these got to do with us here in small, faraway Singapore?

For starters, we should not be too over-reliant on decisions made by FDA, and should develop our own opinions on the matter. This is not to say we have to duplicate all the evaluations, but merely we need to scrutinize all innovative medical devices to form our own opinion as to how much pre-marketing data is required. The FDA is wrong to say "... companies, not the agency, are best qualified to determine whether modifications affect a device's safety or effectiveness." Companies are motivated by self interest. Mostly of the commercial sort. Interestingly the HSA has a pdf file on this Myxo ring, but the file is mysteriously not accessible.

Secondly, doctors do not have the inalienable right to stick all kinds of experimental devices into patients with firstly getting ethics approval, and regulatory approval. It is unclear how many similar annuloplasty rings have been used on our patients without notification and approval of the HSA, or even ethics committees. It remains unclear whether the previously blogged about SAPIENS tricuspid valve prosthesis was approved by the ethics committee as an experimental procedure, since it was not an approved medical device.

Thirdly, proper informed consent by the patient is required. Gigamole notes the favorable developments recently to develop better informed consent procedures. This has been long overdue. Gigamole hopes that the consent process will make the distinction between routine accepted practice and experimental procedures using methods that have not been approved by the HSA. Patients are not all willing to be guinea pigs.

Just a parting trivia...... The company Edwards Lifesciences makes exciting new valves here in small faraway Singapore. Their factory in Changi North Crescent, opened in 2008.

Shooting from the hip: Another unregulated medical devices horror story

Gigamole had posted earlier about the possibility that a recent heart valve replacement surgery may not have been approved. Now for those who still insist on the "I-see-nothing" approach towards the issue of medical device regulation, here is a story to think about before you go to bed. Especially if you were one of those who had received a metal-on-metal hip replacement.

There is a kind of total hip prosthesis manuctured by a company called DePuy Orthopedics, a subsidiary of Johnson & Johnson. These hip replacements called the ASR Resurfacing System and the ASR XL Acetabular System, have metal cups as well as metal heads fitting into the cups. That's why they are referred to as metal-on-metal prostheses.

The prostheses first appeared at about 2003 and 2005 respectively, and were allowed into the US market without the need to do any clinical trials, through an FDA regulatory loop-hole called the 510(k) clearance. All seemed well and rosy until 2007 when Australia, one of the first to have a National Joint Replacement Registry detected that the prostheses had a relatively high rate of failure and surgical revision. Although the company knew about this, it continued to market the prostheses world-wide while phasing it out in the US. In 2010, the UK found similar failure rates and also issued 3 safety alerts. It wasn't just the hip prostheses failing. The metal surfaces grating on each other tended to flake of and expose patients to high levels of chromium and cobalt; some as much as 600 times higher than physiological levels.

In August 2010, the company finally issued a global recall.

In Singapore, these prostheses had been available since 2006. These entered the market and have been in use in patients for 4 years without any kind of regulatory approval. Because we do not have a joint replacement registry like Australia and do not track the post-surgical performance of these prostheses, we have been completely blinded when it came to device failures, and potential toxicities. Without a registry it has been almost impossible to enure that all patients implanted with these artificial joints can come forward to have their replacements replaced. We do not even check on whether these patients had or continue to have cobalt or chromium toxicity.

So patients in Singapore have a very serious problem. How many of our patients even know if they have had a DePuy hip replacement done? (Patients should ask their surgeon and call DePuy) Of these, how many have come forward and have been appropriately advised to get the corrective surgery done, at the cost of the company? Does the HSA know the extent of the problem? How are they looking after our patient's well being? Is anyone tracking cobalt and chromium levels in our patients?

The ASR problem hasn't quite gone away yet despite the global recall in 2010. The manufacturers have set aside billions of dollares to deal with potential lawsuits. Do our patients know they can sue the company?

Recently the BBC and the BMJ jointly reported on this regulatory failure. The manufacturer's apparently continued to market the device despite being aware of the problems.

The Lancet also carried a recent report, after analyzing the Joint Registry data from England and Wales, about how bad these metal-on-metal implants were.

Meanwhile, in Singapore, we don't even have a compulsory registry to know what is going on. The industry, media (and sadly the medical professionals as well) continue to whip up the hysteria suggesting that we should all leave well enough alone and not regulate medical devices at all. Gigamole is all for the HSA taking a stronger proactive position in protecting the interests of our patient-consumer. Methinks they have looked the other way long enough.

Where is Salma Khalik when you really need her?

Was the valve used in National Heart Centre operation approved as a medical device?

While the HSA was conducting their briefing about how they were going to tweak the regulatory processes for low risk devices, we have this bit of exciting news about the groundbreaking operation done at the National Heart Centre.

Exciting because it was the first such operation done in Asia. Essentially, the operation was a minimally invasive insertion of a bioprosthetic (cow tissue in steel) valve to correct for a mitral valve failure. The valve-in-valve design was developed in 2007 when it first underwent clinical studies. In November last year the Edwards SAPIEN valve received a much heralded approval from the FDA. But here is where there is a bit of problem. The FDA approval was only for the use of the valve for aortic valve stenosis, not for correction of the mitral valve. And only in patients who are too ill for open heart surgery. In fact the US FDA had made a note in its approval that the valvular operation, even for aortic stenosis was not without problem - patients had 3 times more chance of developing a stroke.  But there had been no similar FDA approval for a modified valve for mitral valvular disease. Gigamole is not sure if any major regulatory agencies have approved the mitral version of the valve, let alone the HSA.

So here are Gigamole's questions:

a] Did the FDA approve the mitral valve-in-valve as a medical device?
b] Did any regulatory agency world wide approve the mitral valve-in-valve medical device?
c] Did the HSA approve the mitral valve-in-valve medical device?  And if so, on what grounds? If not, what was the approval process for surgeons at the National Heart Centre to go ahead and operate using an FDA and HSA unapproved medical device?

Please do not mistake my questions as being anti-innovation and anti-progress. Devices such as this valve-in-valve device needs to be properly evaluated in terms of risk benefits before use. The aortic version was studied since 2007 before it was approved by the FDA. Although the valve had been modified for mitral valve use also in 2007, this never received the same warm response, and as far as Gigamole is aware, the FDA in its wisdom never gave approval for the mitral valve version. Treating the mitral valve is not as straightforward on terms of risk-benefit assessments as for aortic stenosis. To those who advocate that we blindly follow the FDA's approval must also accept that we should also take guidance from the FDA's tardiness in approving this procedure.

HSA and the regulation of medical devices - an exercise in agenda setting?

The theories of agenda setting are well known, I believe, to all mass comms graduates as well as journalists. Although the formal theories were only formulated about 40 years ago, ideas that the media can influence public opinion have been recognized since the early part of the 20th century.

The recent brouhaha about the regulation of medical devices by the HSA can perhaps be seen in the context of agenda setting. That the media plays an important role in agenda setting is beyond doubt. How the agenda is set however depends on who plays the media. To the media savvy, the media becomes a collaborator in the shaping of public opinion. A media-savvy politician therefore gets a pretty smooth road.

Where HSA failed has been in not recognizing how important the management of public expectations was in the implementation of complex and public-sentiment sensitive policies such as the regulation of medical devices. By defaulting on this, it has willy-nilly allowed the media to set the agenda in a direction contrary to public policy. So, not only has the media been allowed to tell us what issues are important, but it is being allowed to tell us what opinion we should form  about the issue. Note the teaser on the front page of the Straits Times today - "Patients should worry about vanishing medical devices". Really? Vanishing medical devices?

Poor HSA CEO John Lim is in the hot seat now. It seems like it is the fashion nowadays to run down the CEOs! I am waiting for the day when someone flashes an old D&D picture of him on a sedan chair carried by half maked women! But it should be recognized that the move towards regulating medical devices had not been developed overnight, but has been on the stove for about a decade. During this decade, the policy has been deliberated and refined under the guidance of 2 Ministers of Health and 2 Board Chairmen. I guess the second team has been quite unlucky to be on watch when this policy was finally ready to be implemented. But seeing how the SMRT issue developed, it seems highly unlikely even this team will get any credit for the mess. So, sadly, it looks like CEO John Lim will be the one catching the ball.

Regulation of medical devices - a follow up

Even as discussions continue in Singapore between the HSA and medical practitioners, this problem has been brewing in the US of A as well.

Recently, St Jude's Medical, Inc in St Paul, Minneapolis, USA has been involved in a spat with authors of a report entitled "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads" in the Heart Rhythm Journal. St Jude's Medical, Inc are the manufacturers of the Riata electrodes. Concurrently, they have stopped selling two of the electrodes. Electrodes which had been 'approved' by the FDA, ..... apparently.

Truth is the FDA's way of regulating of medical devices is not exactly exemplary. A report from the Institute of Medicine has pointed out major deficiencies in the way the FDA deals with medical devices and have recommended a major overhaul of the regulatory process for medical devices. This will come as no comfort to those in Singapore who advocate blind acceptance of what the FDA pronounces as acceptable.

Globally, the experience in regulating medical devices has lagged far behind the regulation of pharmaceuticals. Is it necessary? Absolutely. But the question of how needs a lot more discussions and harmonizing. This is a rapidly growing problem that badly requires some regulatory solutions. To do nothing will be irresponsible. We need the HSA to be vigilant, and to keep their eyes on  developments not only in the US but in other countries such as Britain, Australia, Canada, Japan as well as the European Community.

So to those who are  targeting the HSA as villains in this regulatory necessity, think again. They would do better to redirect their angst towards those who are making money out of peddling inferior and/or unsafe devices.

Regulation of medical devices? What shocking news?

Woke up this morning to the shocking news of HSA's intention to regulate medical devices. More correctly,  the shocking news of the doctors' responses to the impending regulations. What crap!

Regulation of medical devices have lagged far behind that for pharmaceuticals, and regulations have been long overdue. While pharmaceuticals require extensive testing for safety and efficacy, medical devices have escaped such scrutiny. As a result many poor quality products have been inflicted on unsuspecting patients. These range from breast implants, stents, artificial joints and various other prostheses. (Consumer Reports reviews this problem with reference to a report from the Institute of Medicine. 4 types of devices were singled out - surgical meshes, lap-bands, hip implants and cardiac devices.)

Recently, the French Company making the Poly Implant Prosthese (PIP) gel breast implants were hit by a major scandal when it was discovered that they had been using industrial grade silicone instead of medical grade ones, leading to the company going into liquidation. Of greater concern than the financial woes of the company was the exposure of unsuspecting women to the increased risk of ruptures of the poor quality implants.

Will the new regulations slow down the utilization of medical devices? Without doubt. But this slow down is necessary until manufacturers and doctors get used to dealing with public expectations of quality. Currently device failure rates are not even being monitored so no one has any idea of of how many faulty devices breakdown or fail.

HSA's regulations are both timely and essential for the protection of consumer safety, and we should welcome them. On the other hand, our doctors' hysterical lamentations that these regulations will only increase their practice inefficiencies and reduce the quality of medical care are misplaced, and sound totally self-serving.

Off-label stent use - risky venture

The risk of definitive stent thrombosis is increased after “off-label” stent implantation irrespective of drug-eluting stent or bare-metal stent use

Rainer Hoffmann, Helene Klinker, Malte Kelm and Rüdiger Blindt
Department of Cardiology, University Hospital, Aachen, Germany
Medical Clinic I, University, Aachen, Germany
University Clinic Aachen, Aachen, Germany

Published online: 11 August 2009 Clinical Research in Cardiology

Abstract

Introduction
A limitation of drug-eluting stent (DES) use to FDA-approved indications has been suggested to reduce the risk of stent thrombosis. This study evaluated predictors of stent thrombosis in clinical practice after the use of drug-eluting as well as bare-metal stents (BMS), including adherence to the FDA indications for DES.

Methods
Between July 2002 and October 2006 percutaneous coronary intervention (PCI) was performed on 5,945 patients using BMS (68%) or DES (32%). Patients had 1-year follow-up for definitive stent thrombosis (ARC criteria). 76 patients (1.27%) developed definitive stent thrombosis. Clinical, procedural, and angiographic parameters were related to those of 786 patients without stent thrombosis to define predictors of stent thrombosis. Off-label or on-label implantation of stents according to the FDA-approved indications for DES was included as parameter in the analysis.

Results
In 434 patients, stent implantation was performed within FDA-approved indications and in 428 patients outside of FDA-approved indications for DES. Predictors of stent thrombosis were PCI in acute myocardial infarction (OR = 4.51, P < or =" 4.43,">P < or =" 1.07,">P < or =" 3.67,">P < or =" 6.13,">P < or =" 2.56,">P = 0.014), LV-EF < or =""> P < or =" 3.65,">P = 0.004), stent length in mm (OR = 1.04, P = 0.015), and implantation of multiple stents (OR = 2.64, P = 0.002) remained predictors of stent thrombosis. Off-label stent implantation was no independent additional predictor as it is a combined parameter of the above-mentioned predictors.

Conclusions
Implantation of coronary stents outside of the FDA-approved indications for DES is associated with an increased risk of stent thrombosis using DES and BMS.

Stents and prostheses - are they regulated?

One of the quirky consequences of the way our medical environment has developed is the fact that while pharmaceuticals are regulated to the nth degree, surgical procedures and the stuff surgeons stick into our bodies (e.g. stents and prostheses etc) are hardly regulated at all.

In 2007 the Health Products Act was passed, which to some extent rationalized the regulation of stents and prostheses (collectively called 'medical devices'), but regulation of these things remain, by comparison to pharmaceuticals, barely regulated. The regulations for these medical devices are to a large extent limited to registration, manufacture, supply and advertising. There is minimal expectation of any proof of safety and efficacy.

In otherwords, cardiologists and surgeons are pretty free to stick in any device into our bodies so long as these devices are registered at the HSA. The patient consumer really has no way to determine if any of the very many brands of devices being used have been proven for the disease, or have any reliability with respect to their longevity in the body, or their safety over long periods of time.

One would expect that hospital and clinics performing these procedures (and perhaps the MOH as well) should be collecting data on the outcomes of these procedures where devices are implanted into the body, but this is almost never done. So the patient consumer is really in a very vulnerable position.

To compound the problem, these medical devices are very often used in off-label indications.