As promised, this second installment of the Bard Recovery and G2 series filter story takes a look at one man’s experiences. I’ll also take a look at Bard’s and the FDA’s responses to this issue and compare them to those made by Bayer and the agency in the Essure issue. It’s interesting to see the similarities between these two dangerous devices: Bard IVC filters and Bayer Essure.
Bard’s “profits over patients” decision kept the G2 series IVC filter until 2010. That’s also the year that Chris Svedise was implanted with his G2 filter. Last October, he made an appointment to have his doctor check his filter. Svedise, 69, manages a wholesale fish company in San Francisco and the catch of the day that day was not good. His G2 filter had migrated.
Svedise said the doctor told him, “It is dangerously close to your heart.” Obviously, this news called for corrective action, but two surgeons refused Svedise’s case because of the filter’s new and dangerous location. Enter Dr. William Kuo, an interventional radiologist and the head of the IVC Filter Clinic at Stanford Health Care. Kuo and his team have created a method of extraction for failed IVC filters and filter pieces.
Kuo took Svedise’s case and made another alarming discovery during Svedise’s emergency surgery. Three of the filters legs had previously broken from the filter and traveled to his lungs. Two partially remaining legs broke away during the surgery, one of which could have ended Chris Svedise’s life.
According to Dr. Kuo, “It floated off right in front of our eyes, first into the right atrium and then into the right ventricle. He’s very lucky.”
It does seem that Svedise was in the right place at the right time with the right team. He estimates that he’s removed 1,000 failed filters in the last 10 years, more of them from C.R. Bard than any other company. Several of Kuo’s cases are referrals, like Svedise’s, from surgeons who feel the procedure is too risky for them to perform.
A new clinical trial, dubbed PRESERVE, just started. It’s designed to examine the safety and efficacy of IVC filters currently on the market and involves the Society for Vascular Surgery, the Society of Interventional Radiologists and filter makers, including Bard. The FDA assisted in the organization of the study, which hopes to enroll 2,100 patients over the next 5 years and is the most ambitious U.S. filters study ever conducted.
While it may help correct the problem, it’s also too little too late for those who have already been injured. Kuo is of the opinion that medical device manufacturers and the FDA need to be more proactive and keep patient safety as a focus.
“Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled,” Kuo said. “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices. It’s upsetting to see the patients who have actually suffered from a system that appears to be broken.”
According to NBC News, Bard declined repeated requests for an interview, sent a letter. The company said, “All medical devices carry some level of risk” and, in a separate statement added that its IVC filters are “an important clinical option for physicians.”
The statement also said, “We steadfastly believe in the safety and efficacy of these devices when used as instructed.”
There are similarities between Bard’s filters and Bayer’s Essure, the least of which is that they are medical implants. A Bard VP wrote that of his concerns over the filters migrating, tilting and causing perforations; Bayer’s Essure has been proven to migrate and has caused organ perforations, as well as situations in which corrective surgery was necessary. Essure has been found embedded in uterine tissue and muscles of the back.
There are other, more effective and certainly safer methods available to do the job of both Bard’s IVC filters and Essure. One of Bard’s own vice presidents said that the company made a product that was proven to be safer than the G2 series filter. Traditional tubal ligation has a better success rate of pregnancy prevention than Essure with far fewer dangers.
Both companies like to pour the weak tea of denial when it comes to the damages caused by their products. In fact, Bard’s statement above could very well have been made by a Bayer representative regarding the Essure device. I was going to link a YouTube video in which such a statement was made only to find that, since my last viewing, it had been made private. Interesting for a video issued by a public company…
The FDA response to both the IVC filter and Essure issues has been equally weak. The Recovery and G2 series filters are no longer available, but it took years for that change to occur. Not only is Essure still being widely promoted but despite thousands of adverse reaction reports, the FDA is still dragging its feet on taking any action.
There is one striking difference between the two products though and that is the type of FDA approval each was given. Next week, I’ll explain the 510(k) approval granted to Bard for the Recover and G2 series filters and the PMA granted to Conceptus/Bayer for Essure. Spoiler: injured patients can sue Bard, but not Bayer.