bad medical devices blog

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.

The New York Times reports that heart doctors and makers of medical devices meeting for their annual Transcatheter Cardiovascular Therapeutics convention were made aware that two senators are asking tough questions about financial ties between the doctors and the companies.

The Times says lawmarkers Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin, sent a letter asking the nonprofit group that sponsors the conference, the Cardiovascular Research Foundation, for information about its financial relationships with device manufacturers and drug producers. The senators also sent a letter to Columbia University, which has an affiliation with the Cardiovascular Research Foundation. Two well-known researchers at Columbia, Dr. Martin B. Leon and Dr. Gregg W. Stone, are involved with the foundation; Dr. Leon is its former chairman and Dr. Stone its current one.

In their letter to the foundation, the lawmakers also took note of a comment in an article published last November in The New York Times. In the article, a researcher, Dr. Jeffrey W. Moses, who serves on the board of the Cardiovascular Research Foundation, said that the safety of heart stents “is not the big issue any more.”

The senators wrote: “As you are no doubt aware, there are divergent scientific opinions concerning such products, the safety and efficacy of which are a matter of dispute among cardiologists.”

The letter to the Cardiovascular Research Foundation asked the group to disclose all financing it had received since 2003 from the five device manufacturers named in the letter and also to provide documentation of any payments and benefits the foundation had provided to 22 researchers including Dr. Stone, Dr. Leon and Dr. Moses. The lawmakers asked Columbia to provide information about the disclosures those researchers had made to the institution about their income from industry sources.

At the same conference on Thursday, researchers released results of a new study indicating that a drug-coated stent called Endeavor, made by Medtronic, was linked to more heart attacks and deadly blood clots than the Cypher stent made by Johnson & Johnson.

Medtronic’s new drug-coated artery stent does not compare to that made by Johnson & Johnson, and based on a report, shares of the company dropped in trading this week.

The Medtronic stent has been linked to heart attacks in its patients, an adverse reaction not linked to a similar stent manufactured by J&J.

In a study of more than 2,000 patients, according to The New York Times, the Medtronic Endeavor stent led to more heart attacks and corrective surgeries in its patients than did the Cypher stent, manufactured by J&J.

Neither stent showed a higher frequency of death in its patients, according to a study entitled Sort Out III. It should be noted that Johnson & Johnson sponsored this study and presented it at the Cardiovascular Therapeutics meeting in Washington, D.C., recently.

The news on drug-coated stents struggles to stay positive. With any announcement of an advancement comes the reminders of the dangers of these fairly new medical devices, which have risen in popularity with surgeons since their release.

Some studies show that bare-metal stents act just as effectively, if not better or safer, than the drug-eluting stents.

Aside from heart attacks and the need for corrective surgeries, drug-coated stents have also been linked to blood clots at the site of implantation, despite its successful efforts to unclog an artery.

A Medtronic spokesperson told The Times that the J&J report is in direct contrast to all other studies of its Endeavor stent.

The risk of blood clots on any type of drug-coated stent, including the Cypher stent, is at least four times more likely than if a patient opts for a bare metal stent to prop open a clogged artery.

For Johnson & Johnson to claim its stent is more effective is absurd. In 2003, when the Cypher stent was introduced to the U.S. market, the wire mesh device was linked to nearly 300 cases of severe blood clots in patients who had the device installed not more than six months prior.

A Chicago woman has filed a lawsuit against a surgeon for implanting a heart device without her consent.

In the court filing, according to Forbes, the surgeon was receiving royalties from the company whose device he installed.

Dr. Patrick McCarthy is being accused of implanting the Myxo ETlogix rings in Toni Vlahoulis without receiving her consent. The lawsuit also contends the device was experimental, though it was commercially available.

McCarthy receives royalty payments from Myxo. Medical device and big pharmaceutical manufacturers have been criticized for accepting inflated royalty payments in exchange for promotion of their products.

Criticism falls on physicians who allow these allegiances to the manufacturers, who are often guilty of deception in a rush to get a new device or drug on the market, to override their better medical judgment.

In this Chicago case, McCarthy is being accused of implanting the Myxo rings in a patient without her consent, though the hospital where the surgery was performed, contends Vlahoulis did consent.

Vlahoulis required a corrective surgery to erase the first operation. She is seeking $50,000 in the case.

McCarthy told Forbes he donates the royalties he receives for promoting Myxo to a local charity, the Greater Chicago Food Depository. His royalties, about $30-50 per device, according to what he told Forbes, are donated to the charity, which collects no more than $7,000 annually.

The Wall Street Journal reports that eight medical companies are joining forces to launch a $100 million study to determine how best to protect heart patients from rare but dangerous clots after they are treated with artery-opening devices called stents. The four-year, 20,000-patient study is intended to determine whether stent patients can safely go off aggressive blood-thinning treatment after one year, or if they’d be better to remain on the medication for at least 2½ years after getting a stent.

Current guidelines call for patients who get a drug-coated stent to remain on the medicine for at least a year. But concern over blood clots forming in the devices well after a year has left doctors and patients in a quandary over how long treatment should be prescribed.

Drug-coated stents are designed to prevent scar tissue from reclogging the artery later and thus reduce the need for patients to return for a repeat operation. But such stents hadn’t been studied in those having heart attacks, who make up about 10% of stent patients.

Two new studies suggest that heart patients may be better off receiving fewer artery-opening stents. The devices too often are used indiscriminately, research shows.

The Wall Street Journal reports that these results from a study known as FAME were presented here at the annual Transcatheter Cardiovascular Therapeutics meeting of cardiologists and medical-device manufacturers. And those findings came the same day that an article in the Journal of the American Medical Association reported that, outside of emergencies, most stents are implanted too hastily in the U.S., without a medical test to verify the procedure was needed.

The FAME study suggests that doctors should go beyond the X-ray and measure the blood flow in each artery before implanting a stent. By only stenting arteries that are really choked off, the study suggests doctors could reduce subsequent deaths and heart attacks. In the study, doctors assigned half of the patients to conventional treatment using stents — guided by an X-ray alone. Those patients received 2.7 stents each on average. The other half had their blood flow in each major artery measured with Radi’s equipment. Only truly choked-off arteries were stented, and the patients received only 1.9 stents on average.

Several other cardiologists called the results instructive and predicted they may influence doctors to use stents more carefully. “The message is not, “Don’t stent things,’” said Ajay Kirtane, a cardiologist at Columbia University. “It’s, “Stent the right thing,’” he said.

The Food and Drug Administration has approved the latest version of Boston Scientific’s latest version of its popular, yet controversial, Taxus stent.

In 2006, the FDA cracked down on Boston Scientific about the growing reports of the drug-eluting stent, designed to replace the traditional bare metal stent in preventing artery clogging and closure.

The Taxus stent was reported in numerous complications. It is designed to keep clogged arteries open by emitting a drug built into the stent. Not only have drug-eluting stents been accused of deconstructing, they’ve also been known to cause clots at the site of the stent.

The Liberte stent allegedly makes advancements on design over the Taxus, according to Reuters. The company said Liberte is more flexible than its predecessor.

Last month, the FDA also approved the Taxus-Atom stent.

The Food and Drug Administration has approved the latest version of Boston Scientific’s latest version of its popular, yet controversial, Taxus stent.

In 2006, the FDA cracked down on Boston Scientific about the growing reports of the drug-eluting stent, designed to replace the traditional bare metal stent in preventing artery clogging and closure.

The Taxus stent was reported in numerous complications. It is designed to keep clogged arteries open by emitting a drug built into the stent. Not only have drug-eluting stents been accused of deconstructing, they’ve also been known to cause clots at the site of the stent.

The Liberte stent allegedly makes advancements on design over the Taxus, according to Reuters. The company said Liberte is more flexible than its predecessor.

Last month, the FDA also approved the Taxus-Atom stent.