The U.S. Food and Drug Administration (FDA) has requested additional data be collected about the safety and efficacy of IVC filters currently marketed in the United States. Those are the small metal filters placed in the inferior vena cava (IVC) vein, the largest in the body, to block a blood clot from traveling to the lung or heart.
The investigative studies will address the questions that remain about permanently implanted and retrievable filters. In the meantime, the study will allow the controversial IVC filters to remain on the market, despite what the agency knows about its link to the increasing number of deaths of Americans implanted with the medical devices.
The IVC filters are made by 11 companies. The filter is a one-and-a-half inch piece of metal alloy resembling a spider with long legs. Once placed in the inferior vena cava, it acts like a basket essentially catching blood clots and preventing them from traveling to the heart or lungs where they can cause a fatal stroke or heart attack.
IVC filters can be placed both long-term or until the danger of a pulmonary embolism (PE) has passed, at which time it’s removed.
Unfortunately, the Food and Drug Administration (FDA) issued a warning in 2010 that discouraged leaving an IVC filter in the body for an extended period of time. The FDA recommends IVC filters be removed within 54 days after being implanted, if they are retrievable variety, and if the risk is resolved. The longer an IVC filter remains in place the risk of dangerous adverse events or complications increases.
NBC News recently reported the IVC filters made by C.R. Bard are linked to 27 deaths. Bard reportedly has the worst record for fatalities resulting from patient use of both the Recovery filter and the G2, which was intended to be its replacement.
While about 250,000 of IVC filters are placed each year, many without incident, more than 20,000 patients are still walking around with the Recovery IVC filter in their body.
NBC News did a series of reports talking to victims of the Recovery and G2 filters, made by New Jersey-based C.R. Bard. Profiled was patient, Dodi Froehlich who was involved in a traffic accident. At a high risk for blood clots, she had the Recovery IVC filter placed in her body. After four months she had debilitating headaches and passed out and essentially flat lined at the hospital. A piece of the filter had broken off and pierced her heart. It was predicted she would die and the hospital brought in a priest to deliver final rites, but Froehlich somehow recovered.
After initial reports of adverse events such as this were reported to the Food and Drug Administration, Bard hired a public relations firm. It contracted with an expert to have a study done to outline the real problems with its IVC filters. Dr. John Lehman collected adverse event reports submitted to the FDA’s MAUDE database (Manufacturer User and Facility Device Experience Database) between January 2000 and September 2004.
Bard’s Recovery IVC filter was compared to other manufacturers in terms of relative risks.
The confidential study, produced by Dr. Lehman in 2004, found 27 fatalities resulting from the Recovery. Deaths were blamed on the IVC filter migrating, filter embolization, fracturing and perforating nearby organs and tilting. Filter embolization is a detachment of device components.
Recovery, “is 4.3 times more likely to have a MAUDE report associated with patient death than all other VCFs (vena cava filter) combined, 4.6 times more likely than for permanent VCFs and 2.6 times more likely than retrievable VCFs,” says the report.
The Lehman report showed there were 19,537 Recovery filters sold that resulted in seven death reports. That means there were 36 deaths for every 10,000 units sold. By comparison that is the highest death rate among all 11 filters reviewed in this final report.
The next closes was a death rate of 24 for the OptEASE, a retrievable filter made by Cordis. Vena Tech had 7 deaths as did Greenfield, Bird’s Nest had 15 deaths, TrapEASE had 12 and Tulip had 11.
The Lehman report found 14 deaths per 10,000 sales for a retrievable filter and 8 per 10,000 for a permanent filter.
Filter embolization is the detachment of device components. This essentially leaves a shard of metal free floating dangerously near the heart. The Lehman report looked at filter embolization deaths and found 26 for the Recovery. The next closes was six deaths for the Tulip per 10,000 units sold.
Dr. Lehman concluded “Recovery had an 11.5 times higher reporting rate for filter embolization deaths compared with all other VCFs.”
The conclusion is Recovery has a statistically significant rate of death reports related to filter movement and filter embolization. Only OptEASE (made by Cordis) had an equally high number of overall deaths with a 20 percent death rate.
Even with this information, Bard continued to sell Recovery, which had been on the market since 2003. By the time the newest version of the IVC filter was marketed, Bard had sold 34,000 Recovery IVC filters. The replacement, the G2, was kept on the market for five years during which time Bard sold 160,000 of the medical devices. Unfortunately, at least 12 deaths are associated with the G2.
Both devices are now off the market. They were never recalled by the FDA. The removal was voluntary by the company.
Those thousands of patients walking around with these filters permanently in their body are essentially waiting for the shoe to drop adding to their diminished quality of life.
How did these filters make it to market? You might think the FDA surveyed their safety before approving the IVC filter, but that is not true.
Even though they are permanently implanted, they are considered a class II or moderate risk device. That allowed them to enter the market under the FDA’s 510(k) approval, essentially an exchange of paperwork that fast-tracks a device to market bypassing any clinical trials.
The post approval monitoring will take place after the fact, with the devices already in patients, sort of a like a real-life clinical trial with the unsuspecting patients as the participants, an arrangement they never agreed to.