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What's A Patient To Do?
Getting answers to questions about product recalls and device safety
(updated September 14, 2006)

Technology Keeps Changing
Interventional cardiology is a relatively young and rapidly evolving field of medicine. Minimally invasive treatment of heart disease with catheter-based devices (balloons, stents, etc.) began thirty years ago. Since that time the field has grown exponentially, driven by technological innovation—by the time one procedure reaches widespread usage, a new technology comes along to replace it.


Physicians and device manufacturers are eager to make new innovations available to patients. Each new technology is an effort to make the treatment of heart disease safer, less invasive or more effective. But often it is not until a procedure goes into widespread use that rare adverse events begin to show up, or long-term complications with new technologies emerge.


Scary Headlines
When problems with medical devices do surface, they quickly make headlines. In 2004, 90,000 Boston Scientific Taxus drug-eluting stents were recalled (for detailed information on the recall, read our feature article, “Taxus Stent Recall). In 2006, after drug-eluting stents had been in use for over 3 years, studies came out that indicated a possible risk of dangerous blood clots, a year or more after stent implantation.

When patients who have received or are scheduled to receive a stent open their morning newspaper and read reports of a recall, or possible fatal blood clots, it is understandably disconcerting. Their first thought: how does this affect me? As Dr. Stephen J. Green, an interventional cardiologist at North Shore University Hospital in Manhasset, New York, told Reuters after the 2004 recall, “Patients read the newspapers and watch TV...we [got] calls from patients on a daily basis wanting to make sure they didn't get the Boston Scientific stent.”

Stephen J. Green, MD
"Patients read the newspapers
and watch TV..."

-- Stephen J. Green, MD
North Shore University Hospital, Manhasset NY

The problem with the Taxus stent was quickly identified and resolved —a handful of balloons had failed to deflate due to structural defects. The number of patients affected was extremely small, but for patients, the question of what to do when this kind of event occurs is an important one. In 2003, the Cypher™ coated stent, made by Johnson & Johnson, was the subject of two warning letters from the FDA, also causing much concern among patients, some of whom, fearing that the device was defective, asked their doctors if it could be removed. (The problem with the Cypher stent was not structural, but related to emphasizing correct sizing by the physician and adequate post procedure antiplatelet drug regimens for patients.)

Felix Millhouse, MD
"This is a breakthrough technology."
-- Felix Millhouse, MD
San Francisco Heart & Vascular Institute

Physician Response
After the Taxus recall, Dr. Felix Millhouse of the San Francisco Heart & Vascular Institute at Seton Medical Center in San Francisco concluded: "The company has done a good job identifying the problem and fixing it.” Generally, although many had questions, physicians were reassured by announcements from Boston Scientific regarding its actions in the wake of discovering the deflation problem.

Dr. Gregg Stone of Columbia Presbyterian Hospital in New York told Angioplasty.Org, “They found a cause for it, a very rare cause for it…they were able to fix it…they took the responsible move to recall all the lots that even had a chance of having one-in-100,000 catheters affected…I am very comfortable continuing to use the product as my primary stent.”

Brigham and Women's Hospital in Boston was reportedly one of the first to pull the Taxus stents off its shelves (they restarted its use two weeks later) but Dr. Donald S. Baim told Angioplasty.Org that "the media sensationalized was not an issue if you had already gotten a stent...and they only gave the numerator (95 non-deflations) never the denominator (over a million cases)." He noted, at that rate, his lab might have seen one problem in 50 years.

For patients, the situation is a bit more complicated. They are less familiar with the science, so it is difficult to understand the technical issues involved in the design and manufacture of sophisticated medical devices. Though extremely rare, non-deflation was potentially very serious, potentially fatal. When it's your body, any implication that a procedure may not be 100% safe is frightening.

Donald S. Baim, MD
"It was not an issue if you had already gotten a stent."
-- Donald S. Baim, MD
Brigham and Women's Hospital, Boston MA


Gregg W. Stone, MD
"you’re talking about very rare events that might occur in one-out-of-a hundred thousand patients"
-- Gregg W. Stone, MD
Columbia University Medical Center NY


Put rare problems in perspective
The Taxus stent, like all medical devices, was subject to extensive trials and testing before being approved by the FDA. The Taxus IV clinical trial involved 1,326 patients at 73 sites. Dr. Gregg Stone, who was the chief investigator for that trial, told, “I actually think it should almost be anticipated that there are going to be problems that will arise along the way, especially when you’re talking about very rare events that might occur in one-out-of-a hundred thousand patients or so, that you can’t possibly detect in a clinical trial.”

It was only after one million Taxus stents had been implanted that reports surfaced of 95 confirmed incidents of non-deflation with three resulting deaths. By contrast, the odds of death resulting from routine general anesthesia are one-in-200,000. Routine balloon angioplasty/stenting has a complication rate of around one percent. All medical procedures carry a degree of risk and it's very important to put risk in perspective. But of course, it is essential to eliminate all preventable risks.


related stories:

• Report States FDA Drug Safety System is Broken

• Patient Advisory on Late Stent Thrombosis

• Problems Resurface with Drug-Eluting Stents

• "You and Your Physician": Improving Communication between Doctor and Patient

• Cardiology Patients' Discussion Forum

As of September 2006, researchers and regulators are reviewing reports of possible late-stent thrombosis after drug-eluting stenting. Current estimates are that there is a 1 or 2 in 100 chance of late stent thrombosis (a blood clot), a problem that can usually be prevented by continuing anti-clotting medications.

Maintain Healthy Skepticism
The FDA is currently reviewing its procedures for gathering and analyzing data about adverse events after devices are approved and enter widespread use. The truth is, companies and regulators sometimes fail to adequately follow-up over the long term with patients and physicians in order to monitor the results and side effects of procedures, drugs and medical devices. (Regulators are investigating problems with the painkiller Vioxx and recalls of implantable heart rhythm devices, for example.)

Physicians and the government are hesitant to create unnecessary panic by announcing suspected problems before they have been proven. Of course, companies don't want to lose revenue by drawing attention to adverse events and risks associated with devices.

Patients are understandably wary: for example, after the medical profession dramatically reversed its decades-long practices regarding hormone replacement therapy for menopausal women, patients learned that studies are not always foolproof, that medicine doesn’t always have all the answers.

Weigh Risk and Benefits
Most patients want to avail themselves of the best medical science has to offer. Patients, with the help of their physicians, should look at the risks/benefits of recommended treatments and assess what is acceptable to them. It makes sense to stay informed of medical news. Educated patients are in the best position to discuss with their physicians whether a cardiology procedure or device is appropriate for them.

By all means, look at all the alternatives and at the medical thinking behind the treatments that are recommended. If you are more comfortable with an older, more established procedure, discuss this with your physician. But no medical intervention is entirely risk-free. It's a matter of deciding which risks are more acceptable to you.

Dr. Gregg Stone states, “I think that the better educated patients who can participate in their care will be more compliant with treatment plans and will ultimately do better.” This opinion is echoed by many, among them Dr. Rajesh M. Dave of Harrisburg Hospital in Pennsylvania who told us, "It's actually a much better thing for [patients] to know about the procedure and what we are going to do and what they might expect, than if they don't know anything and if there is ever a complication, it comes as a surprise to them."

Work with Your Physician
Patients today have access to complex medical information. Medical issues are usually not black and white, and there are differences in opinion among medical professionals regarding the efficacy and advisability of numerous drugs and procedures.

Yet it is still the physician-patient relationship that is key to obtaining quality healthcare. Folloqing are our recommendations to patients who have questions regarding medical devices and procedures:

  1. Learn a bit about the science; it can be reassuring to understand the specific nature of a recall or safety problem and how it is being resolved. You can visit independent web pages like this one. You can also review company web sites. And you can look at the FDA site for information on its policies, procedures and any current warnings or recalls.
  2. Think about yourself, consider your priorities and preferences. Try to find a doctor who is willing to make decisions with you. If you’re having trouble, try this interactive online tool to help with healthcare decisions:
  3. Ask your doctor questions. Tell your doctor any specific technical concerns you may have about a device. .Assure yourself that your doctor is up to date on the latest recommendations and practices regarding use of a device or medicine. Discuss any concerns you have about news reports.

Ask your doctor:

  • Why have you chosen this procedure/device for me?
  • Why have you recommended this procedure right now?
  • What is your experience with this procedure?
  • What are the relative risks and benefits of this procedure?
  • What are my alternatives?
Rajesh Dave, MD
"We have seen a trend over the last six months...the majority of the information is coming from the Internet."
-- Rajesh Dave, MD
  The physicians we interviewed for this article agreed that when doctors clearly explain their recommendations and answer patient questions, it results in physician-patient trust and increased comfort with treatment choices. These physicians are urging patients to go to the web, to become informed and to ask questions so that they can get the best healthcare possible.

Dr. Rajesh M. Dave told us, "We've seen a trend ...that patients have been asking us to put in the newer coated stents because they have heard a lot about it preventing restenosis...the majority of the information is coming from the internet. They are probably doing an ‘angioplasty’ search, and there you go!" Dr. Dave believes this is a positive trend, as does Dr. Stephen J. Green of North Shore, who told Angioplasty.Org, “When I first started here, almost 25 years ago, it was, you know, respect the doctor. Don't ask him questions. He knows what's right. And that whole process has changed. And that's the right thing. It's an informational age. It's appropriate for patients to know what's going on, and I don't expect patients to be able to be their own physician, but they can ask serious and reasonable questions -- and they demand and should get reasonable answers.”

For the latest news about developments in the field, go to our Drug-Eluting Stent NewsCenter. We welcome your comments on this article.

Source: Angioplasty.Org, September 8, 2004 -- revised October 6, 2004, September 14, 2006

CONTACT: Burt Cohen, Producer of Angioplasty.Org


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