bad medical devices blog

More and more research indicates hip resurfacing surgery, used an alternative to total hip replacement for middle-aged women, often leads to more failures and the need for a follow-up surgery.

Hip resurfacing surgery aims to preserve more of the femoral bone than the traditional total hip replacement.

Resurfacing has been used in Europe and Australia longer than it has been used in the U.S., and much of the research is based on findings there.

Physicians find that the need for a corrective or follow-up surgery increases when resurfacing is performed.

Part of the reason the procedure is done is to provide patients who are bound to outlive the lifespan of a traditional hip replacement, and provide an easier surgery when that is necessary later in life.

Women are most likely to develop the complications associated with hip resurfacing, according to The New York Times.

In a recent U.S. study, women of all ages receiving this surgery are more at risk for complications, certainly more so than men.

Physicians have not determined a way to screen female patients, mostly in their 50s and 40s, to see who’s most at risk from developing complications from hip resurfacing surgery. All patients, male and female, are considered bad candidates for the procedure.

The bone-weakening that occurs during menopause seems to be a major factor in determining who is best for the procedure.

But despite the mounting evidence against the resurfacing procedure, more and more patients are getting it. In fact, hip replacement surgeries are increasingly popular in patients much younger than typically thought.

The device that was the subject of the intense American study was Smith & Nephew’s Birmingham hip resurfacing system, approved by the Food and Drug Administration in 2006.

A cardiologist at Beth Israel Deaconess Medical Center told the American Heart Association conference on Sunday that headphones and earbuds (popular with MP3 players and iPods) can alter the performance of implanted heart devices.

These devices include implanted defibrillators as well as pacemakers and can fail to operate if headphones are kept too close to the device, even if the phones are not in use, or even connected to their device.

The cardiologist said that headphones contain magnets and can affect the devices. Some of the magnets, he said, can be powerful.

According to Associated Press, more than 2 million people have some form of implanted cardiac device which could be affected by foreign magnets.

Patients are urged not to overreact to the discovery, but should be mindful of where they keep their headphones. Putting them in a shirt pocket or resting around the neck is not suggested.

Food and Drug Administration investigations into the effects of iPods and MP3 devices on heart devices resulted in no significant findings.

For this study, however, the headphones were examined, not the player itself.

In 60 patients who kept the headphones about one from the device, interference occurred about 25 percent of the time.

Four in 27 pacemakers reacted to the headphone magnet exposure. Ten of 33 defibrillators reacted unfavorably as well.

Interference could cause these devices to not send a life-saving shock to the heart or cause heart palpitations unexpectedly.

The Food and Drug Administration recently announced it is notifying health care professionals and patients that Tyco Healthcare Group is recalling one lot of ReliOn insulin syringes due to a possible mislabeling.

The syringes are the sterile, single-use, disposable, hypodermic syringes with permanently affixed needles. The label error could lead to patients to administer a dose more than two times their normal level.

Patients who get as much as 2.5-times the amount normally needed could develop dangerous side effects like hypoglycemia or even death.

The Lot No. affected by the recall is 813900 and specifically is the ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin syringes.

The syringes are distributed by Can-AAm Care Corp and sold only by Wal-Mart at its stores and at Sam’s Club stores under the name, ReliOn. Any customers with these syringes is requested to return them to the store for a replacement.

The FDA and Tyco Healthcare Group want patients and professionals to carefully check the labels on the syringes.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

The one lot in the recall may sound small but includes 471,000 individual syringes. They were sold at Wal-Mart from Aug. 1 until Oct. 8. Tyco announced the recall on Oct. 9.

When the syringes were packaged, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

There has been one report of an adverse reaction, according to the FDA, but did not specify what that was.

Medtronic has released updated figures on its defective Sprint Fidelis defibrillator leads, recalled in October of last year for fracturing/malfunctioning and killing several people, injuring hundreds of others.

WebMD reports Medtronic yesterday released updated data showing that the leads, have had 42-month failure rates of 6.3% based on SLS figures and 3.8% according to the CareLink data.

According to a report published online by Circulation the same day, WebMD reports, software that can be downloaded into Medtronic ICDs provided a warning at least three days before an inappropriate shock, one of the consequences of lead failures, in 76% of a cohort of almost 16 000 patients, compared with a three-day-warning rate of only 55% provided by optimal impedance monitoring (p=0.007) [2]. The study, from Dr Charles D Swerdlow (Cedars-Sinai Medical Center, Los Angeles, CA) and associates, some of whom were Medtronic employees, was a retrospective simulation of the two monitoring features’ warning capabilities.

“Although we believe some physicians will be concerned by a failure rate above 5%,” Wachovia Capital Markets analyst Larry Biegelsen has written in a report to investors, “key opinion leaders with whom we have spoken have indicated that a failure rate above 5% would not justify lead removal or replacement, in part because the new software mentioned above provides ample warning for the majority of patients.”

Medtronic also sent a letter to patients with the leads that says their physicians have received “updated information” regarding the leads [3]. It doesn’t further elaborate, except to note, “The chance that there will be a problem with your Sprint Fidelis lead remains small.”

The FDA has announced yet another Class 1 recall of a medical device claiming to cure cancer and other diseases and conditions. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices.

The recalled medical device is called Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator, made by VIBE Technologies. The company’s labeling reported that the device could be used to treat or cure medical conditions and diseases such as: cancer, depression, infection, pain. The firm has failed to provide FDA with any evidence to support these claims.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Kickback payments from medical device makers to orthopedic physicians in exchange for the promotion and use of a specific hip or knee replacement have begun again.

In Sept. 2007, the medical device industry was forced to stop these payments and several thousand doctors across the U.S. actually stopped receiving these bonus payments they received in exchange for their support, both spoken and applied, of a specific medical device.

But in a settlement agreement, in which medical device makers agreed to pay out $311 million and agree to federal scrutiny on the money it gives to physicians, the payments can begin again … and have.

Patients about to undergo a joint replacement surgery should be alert and aware of these payments and that their physician could really be on the take.

If the government finally holds its end of the settlement, physicians should be forced to report money they receive in consultation fees. These figures should parallel information the government also receives from device makers on the money it has paid for these services.

The settlement is also criticized for allowing medical device makers to walk away without admitting any payment they made was wrong.

Hip and knee replacement makers Zimmer Holdings and three other major device makers reportedly paid out $800 million between 2002 and 2006 to more than 6,500 doctors.

Last year, nearly 50 physicians reportedly received at least $1 million apiece from device makers.

These payments went unchecked and physicians were on the take for at least the early part of this decade. Patients were left clueless to these payments and would have no idea if they were being forced into a surgery and artificial joint that could not be their best choice.

We’ve recently reported on this blog about the growing number of hip and knee replacements being performed in an increasingly younger generation.

An executive at Biomet, a smaller competitor for the likes of Zimmer, told its Wall Street investors recently that the company would continue its consultation payments as it did prior to September of last year.

After five deaths, the Thoratec Corporation has issued a worldwide recall of its Heartmate II Pumps. The implant, which is used as a temporary solution for patients waiting for heart transplants, has the potential to malfunction and kill those implanted with it.

The FDA’s recall notice states that wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The FDA advises partients who are currently being supported by a HeartMate II LVAS tocontact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. Five patients who had to undergo the operation to replace the pump initially survived the surgery but then died 30 days or more following the pump replacement.

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage.

The FDA on October 20 sent a letter to healthcare practitioners warning about complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences.

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI, the warning letter stated. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.

Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

The FDA’s letter to physicians said doctors should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

The FDA urges patients, before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene. Questions patients should ask the surgeon before agreeing to surgery in which mesh will be used:

• What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
• If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
• What’s been your experience in dealing with the complications that might occur?
• What can I expect to feel after surgery and for how long?
• Are there any specific side effects I should let you know about after the surgery?
• What if the mesh doesn’t correct my problem?
• If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
• If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

University of Minnesota Medical School is considering a new conflict-of-interest policy so strict that doctors wouldn’t even be able to accept Post-it Notes bearing a drug company’s logo, the Star Tribune reports. The far-reaching policy, which if enacted would be among the toughest in the nation, comes as congressional investigators and the U.S. Justice Department are probing ties between doctors and drug companies and medical device manufacturers — probes that have raised some difficult questions for the university.

This decision comes at a time when ties between the medical device industry and doctors are being scrutinized for putting the lives of patients at risk.

The Wall Street Journal reported last month on complications associated with off-label use of Medtronic’s Infuse Bone Graft, including cases where it has caused dangerous swelling in the neck. Infuse is a manufactured version of a naturally-occurring protein that promotes bone growth. It is approved by the U.S. Food and Drug Administration for use in the lower back, but surgeons say it is used widely off-label in other parts of the spine.

Doctors with financial ties to Medtronic have been among those promoting the off-label use of Infuse. Former employees have alleged the company induced doctors to use Infuse and other spine products by sending them on lavish trips to resorts, paying them undeserved royalties, and handing out lucrative consulting contracts that required little work. Patients have become life-threateningly ill, and doctors are being sued.

The Star Tribune reports the Medical School’s proposed policy digs deep and reaches far into the entrenched relationship between the drug and medical device industries and the university’s doctors, researchers and students, as well as the institution itself. If adopted, the policy would profoundly alter the relationship between industry and the state’s largest medical school. All personal gifts from industry would be banned. Free drug samples would be limited. Industry support for doctors’ continuing medical education would be phased out. Doctors’ consulting relationships would be disclosed to both patients and the public. Those financial ties would be monitored far more closely.

“It’s really putting policies in place that would, as best as possible, ensure the patient’s best interest,” said Dr. Leo Furcht, co-chairman of the task force recommending the rules and chairman of the U’s Department of Laboratory Medicine and Pathology.

A year after the big Medtronic defibrillator recall, only a few defective wires that connect defibrillators to hearts have been replaced, the Toledo Blade reports some Toledo cardiologists say.

Last October, Medtronic recalled its Sprint Fidelis lead, the wire connecting the implanted defibrillators to the heart, after four reports of death due to fracturing lead wires. In some cases, multiple heavy voltage shocks killed patients and in other cases the wires fractured and failed to deliver the lifesaving shocks the defibrillators were implant to deliver. Many who didn’t die were severely injured, but still were advised not to have their defibrillator lead wires replaced due to the fatal risks of having such a surgery.

The Toledo Blade now reports that at the University of Toledo Medical Center, the recalled Sprint Fidelis leads made by Medtronic were removed from three of 80 patients with them.

“If we electively started taking all the leads out, there would be significant morbidity and mortality,” said Dr. Kanjwal, who uses an ultraviolet laser procedure to help remove leads encased in heavy scar tissue. He added: “It is not an innocuous procedure.”

The Toledo Blade reports that St. Vincent Mercy Medical Center has had about four cases where questionable defibrillator leads were replaced out of nearly 500 patients with them, per Dr. Ameer Kabour, section chief of cardiology. Other patients with the Fidelis leads are monitored more frequently than usual, Dr. Kabour said. Some patients were concerned at first, but they have been reassured by explanations, he said. Two additional patients were referred to the former Medical College of Ohio for the operation for a total of five removals, UT cardiologist Dr. Yousuf Kanjwal said.