Zimmer Holdings suspends sales of Durom Cup hip implant amid doctor complaints

Surgeons say device failure necessitates additional patient surgery

On July 22, 2008, Zimmer Holdings, Inc. announced it will suspend marketing and sales of its Durom® Acetabular Component (Durom Cup) in the United States. The suspension is due to complaints from doctors that the artificial hip component is failing at a high rate.

The Durom cup is used in total hip replacement procedures, which are performed in more than 442,000 patients in the United States each year. The cup was developed to relieve pain and improve joint function in patients with severe hip degeneration due to arthritis or trauma.

In the months leading up to the suspension, some doctors complained the device was failing in their patients, who then underwent replacement surgery. Zimmer received complaints about loosenings of the Durom cup, prompting the company to launch an investigation to determine whether the product was defective.

The investigation found that experienced surgeons reported difficulty implanting the Durom cup. Zimmer asserts the product is not defective. Zimmer also cited evidence that the product was doing well in Europe, but the version of the Durom cup used in Europe differs from the version used in the United States. Surgeons in other countries also perform a different, relatively new kind of hip surgery.

Zimmer said sales and implantations of the Durom cup are to be halted until it can update the products label to provide more detailed surgical technique instructions and implement a surgical training program.

The Durom cup was first sold in the United States in 2006, and has been implanted in more than 12,000 patients. Zimmer expects the number of early replacement surgeries needed to be minimal, but hundreds of patients may need replacement surgeries in the next several years.

Sources: Barry Meier, “Complaints undermine hip device,” The New York Times, July 24, 2008; “Background on Durom® Cup Status,” Zimmer Holdings, Inc. announcement, July 22, 2008.

Oklahoma women file lawsuit against Vaginal Sling

Incontinence device causes pain, infections, women say

Some women from Oklahoma have sued California-based medical supply company Mentor Corp., claiming the company’s device to treat urinary stress incontinence is defective and caused them serious injuries.

The women filed three lawsuits on Feb. 29 in Payne County District Court, alleging the ObTape Vaginal Sling caused chronic pain, infections, and erosion of vaginal tissues, among other problems. The Mentor Corp., based in Santa Barbara, has not commented on the suits.

“It felt like someone had pulled my legs apart and just stretched them,” one claimant said at a news conference. “I was finally relieved to know what caused it; you keep wondering what was wrong with you.”

And for some women, simply realizing they had the device was a surprise.

“We have found many women do not know they have this product inside their bodies,” one lawyer said.

Source: The Associated Press, “Oklahoma women file lawsuits against medical device maker Mentor,” March 18, 2008. (http://www.cnbc.com/id/23695109/for/cnbc/print/1/displaymode/1098/)

Medtronic death rates snag FDA’s attention

There may be a higher death rate after five years among patients treated for abdominal aortic aneurysms with a Medtronic Inc. device than among those treated through conventional surgical means, according the U.S. Food and Drug Administration.

A public-health notification posted on the FDA’s Web site said the agency was looking at Medtronic’s AneuRx stent-graft system because it is the only currently marketed device that has a significant number of patients who have been examined for at least five years after receiving a device.

The device is generally inserted through an artery in the leg in order to prevent bulging blood vessels in the abdomen from rupturing, which can be fatal.

Source: Jennifer Corbett-Dooren, The Wall Street Journal, “FDA Notes Medtronic Device Deaths,” March 19, 2008.

Medtronic, Inc. disputes details of “Sunshine Act”

The “Sunshine Act,” introduced in Congress earlier this year, states that medical device manufacturers must publicly disclose particular monetary transactions involving physicians who assisted with product training, development, and research.

The purpose of the bill is to help prevent inappropriate relationships that may form between physicians and medical device makers.

Medtronic, Inc., a manufacturer of medical devices such as defibrillators and insulin pumps, disputes the bill for not including all companies that make devices. In its current form, the bill does not include companies with annual revenues of less than $100 million. The bill also does not include physician-owned companies. Medtronic alleges that 75 percent of medical device manufacturers fall into one of those two categories and should be included in the bill.

Source: Toni Clarke, “Medtronic says ‘Sunshine Act’ should go further.” Reuters.com, http://www.reuters.com/article/rbssHealthcareNews/idUSN2634844420080226 February 27, 2008.

Patient sues Medtronic over painful lead shocks

Donald Jackson received a defibrillator implantation in 2006 that included a lead wire manufactured by Medtronic, Inc. The lead, known as the Sprint Fidelis, was voluntarily recalled by Medtronic in late 2007 amid reports of unnecessary and repeated shocks to patients as a result of fractures to these leads.

Jackson has sued Medtronic, claiming he suffered excruciating pain when he was subjected to unnecessary shocks, and now requires psychiatric treatment to deal with the ongoing stress of his predicament.

Defibrillators are intended to administer electric shocks to a patient’s heart in order to regulate an abnormal heartbeat. Lead wires implanted directly in the heart muscle connect to the defibrillator unit, sending information to the unit about the patient’s heart rhythm. A break or “fracture” in the wire results in mixed electrical signals being sent to the defibrillator that may cause unnecessary painful shocks to the patient. Sprint Fidelis leads were recalled after Medtronic acknowledged that the leads have a higher failure rate than that of their predecessor product, the Sprint Quattro lead.

In the current lawsuit – one of many such suits filed across the country – Jackson claims his Sprint Fidelis lead is defective and has caused much “physical, emotional, and psychological suffering and extreme anxiety.” Jackson has been prescribed medications to deal with his anxiety, but claims he still has an “imminent apprehension of death.” The suit also alleges that “as a result of problems with the lead, [Jackson] has an increased risk of death or major heart problems.”

Jackson seeks punitive damages from Medtronic on the basis that the company acted in an “intentional, reckless, and grossly negligent” manner in the manufacture and marketing of the Sprint Fidelis lead. Suit was filed on January 18, 2008, in U.S. District Court.

Source: “Lead Shocks Send Patient to Psychiatrist, Courtroom.” Fdanews.com, February 4, 2008.

Medtronic settles 2,682 lawsuits for $114.1 million

Medtronic Inc. announced today a $114.1 million agreement to settle 2,682 lawsuits related to its implantable Marquis cardiac defibrillators. Still, the Minneapolis-based company said it does not admit liability or the validity of the plaintiffs’ allegations in litigation against the defibrillators.

“We are pleased to settle these cases and put the matter behind us,” said Pat Mackin, who is the senior vice president and president of Medtronic Cardiac Rhythm Disease Management. “We know the Marquis line of defibrillators continues to provide life-saving therapy for thousands of people around the world, and they remain among the most reliable ICDs ever manufactured by Medtronic.”

The announcement comes nearly three years after Medtronic announced a potential battery shorting problem in the Marquis-brand defibrillators in February of 2005. Some 13,000 devices were surgically removed and replaced worldwide.

According to the suits against Medtronic, the company knew for years that there was a potential for defects but sold the devices nonetheless, failing to advise patients that there were safer devices available.

Source: CNNMoney.com, “UPDATE: Medtronic Settles ICD Lawsuits for $114.1 Million,” December 21, 2007.

Bayer forced to recall Contour TS diabetes strips in seven countries

Bayer AG announced a seven-country recall of Contour TS diabetes test strips due to a manufacturing problem that could lead to blood sugar readings higher than actual levels of glucose. According to a release from the U.S. Food and Drug Administration, glucose test results returned by the recalled strips generally show up five to 17 percent higher than the user’s actual glucose levels.

The recalled Contour TS test strips have lot numbers beginning with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). The recalled lots have the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence.

Consumers may contact Bayer at 1-800-348-8100 to return recalled test strips for a replacement.

Source: U.S. Food and Drug Administration, MedWatch, “Test Strip Recall for CONTOUR TS,” December 21, 2007.

Cardinal Health updates consumers on Alaris Pump recall

Two deaths could be associated with Alaris pump, FDA says

Cardinal Health and the U.S. Food and Drug Administration updated the public on a worldwide recall of Alaris Pump modules today, informing consumers that the medicine-infusion systems may overinfuse, which could prompt serious, life-threatening side effects. The Alaris Pump recall involves model number 8100, which was formerly known as the Medley Pump.

According to the FDA’s statement on December 20, 2007, the recalled Cardinal Health Alaris Pumps may contain occluder springs that are bent, broken, nested, or missing. This could cause the pump to malfunction, and perhaps lead to overinfusion of medicine. But according to the FDA, overinfusion can be difficult to detect because there is no warning or notification from the pump itself that it is injecting too much medicine.

Cardinal Health has received one injury report and two reports of patient deaths associated with use of the recalled Alaris Pumps, however the company maintains that neither they nor the respective hospitals could confirm that use of the device definitively caused the deaths.

The FDA urges consumers to contact Cardinal Health with any inquiries related to the recall. The company’s phone number is 1-800-625-6627, and its Web site is www.cardinalhealth.com. According to Cardinal Health, it will have representatives answering phones around the clock, seven days a week.

Source: U.S. Food and Drug Administration, “Cardinal Health Statement on Alaris Pump Module Worldwide Voluntary Recall,” December 20, 2007.

Consumer Union wants FDA to strengthen medical device warnings in ads

A consumer advocacy group wants the United States Food and Drug Administration (FDA) to warn consumers about infection risks and the limited lifetime of implanted medical devices in product ads.

Consumers Union is targeting advertisements for implantable devices, such as knee implants, and cosmetic implants in its petition to the FDA.

“We are only asking that consumers be given clear warnings about the dangers of infection during and following surgery,” the petition reads. “And information about how the devices are likely to last, and that consumers be advised to seek out facilities with the strongest anti-infection programs and devices with long term data about failure rates.”

The petition cites a June 2006 publication of Consumer Reports, in which a study found five percent of respondents reported having an infection after implant surgeries. Some of those infections were of Methicillin-resistant staphylococcus aureus (MRSA), which can be lethal. Other postoperative infections cited were deep vein thrombosis (DVT), pulmonary embolism, and decubitus ulcer.

Consumers Union is an independent and non-profit organization that publishes Consumer Reports.

Source: Consumers Union, Citizen Petition to the U.S. Food and Drug Administration, December 11, 2007; “Drug-resistant bug raises new concerns,” Consumer Reports, June 2007.

Medtronic patients worry about faulty Sprint Fidelis defibrillator lead

Cost, health risk to replace wire is high

On December 11, 2007, a 48-year-old man underwent surgery to have his Medtronic defibrillator and lead wires replaced after the Sprint Fidelis lead was linked to five deaths.

A defibrillator is meant to deliver electric shocks to the heart to restore normal rhythms if a patient’s heart starts beating erratically. During implantation of the device, lead wires are also implanted that connect the defibrillator to the patient’s heart. One of the most widely-used leads, the Sprint Fidelis lead, was recently pulled from the market when its’ manufacturer, Medtronic, announced that the Sprint Fidelis lead carries a higher risk of failure (fracture) within the first 30 months of use than its predecessor product, the Sprint Quattro lead.

If a lead fractures it could prevent the defibrillator from firing when needed. Fractured leads may also suffer from disruptions in their sensing mechanism, causing them to deliver unnecessary and perhaps repeated shocks.

In some instances a defibrillator is implanted to serve a dual purpose, also acting as a pacemaker for the patient’s heart. In these situations the failure of a lead like the Sprint Fidelis lead could have devastating consequences for the patient.

The December 11 surgery came two months after Medtronic warned doctors and patients that the lead might break. The warning has left many patients wondering if they should have the faulty lead removed, or leave it in place and hope it does not fracture.

The risks involved during removal surgery, besides infection, include perforation of the heart and veins in the chest. Some patients also face a risk of damage to the heart valve through which the Sprint Fidelis lead lead was threaded.

Each lead replacement procedure can cost $12,500 or more. Medtronic has offered only to contribute a replacement lead and $800 towards the procedure, and insurers are debating whether to cover the surgery on a case-by-case basis.

While most Sprint Fidelis lead users will not need the operation, all have been advised to check with their doctors. The number of patients potentially affected by the faulty leads – nearly a quarter of a million – makes this the most widespread heart device problem in the country’s history. It is the latest example of errors in a medical device industry that has been plagued by design defects, lax quality control, and product recalls such as the Guidant defibrillators in 2005 that were linked to seven deaths.

“It seems like a good time to figure out where we are in regulating leads and what we can do better,” said Daniel G. Schultz, director of the FDA’s center for devices and radiological health.

A Detroit woman said her husband had his Sprint Fidelis lead reprogrammed to safer settings by a Medtronic representative, but still planned to seek a second opinion at the Cleveland Clinic.

“Maybe nothing will happen,” she said, “but if it does I want him to be a patient of someone known to be a high-volume expert.”

In October 2007, Medtronic said the Sprint Fidelis lead fractures at a higher rate than the Sprint Quattro, which Fidelis has been displacing since 2004. Data from Medtronic suggests 2.3 percent of Fidelis implants fracture within 30 months. While experts believe data from the lead’s manufacturer is likely conservative, even at these estimates some 4000-5000 patients in the United States are at risk of fracture.

Dr. Raymond H.M. Schaerf, a surgeon at Providence St. Joseph Medical Hospital in California, has removed six Fidelis leads from patients since the October 2007 warning. Dr. Schaerf also said he has turned 10 patients away, though, indicating replacement procedures are too risky in those particular patients’ situations.

Robert G. Hauser, a Minneapolis cardiologist, said he is organizing a registry to track performance of the Sprint Fidelis lead and other leads, in order to get a better grasp on the specific risks involved.

Source: Barnaby J. Feder, “Patients wonder whether to replace a wire that might fail,” New York Times, December 13, 2007.