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A number of deaths and other reports of serious complications associated with the Recovery blood clot filter have raised questions about its safety, according to an investigation by NBC reporters.
The C.R. Bard blood clot filter, the Recovery, has been identified in about 300 reports submitted to the government noting problems with the medical device, in addition to 27 deaths.
According to government data, pieces of the filter have been known to break off and migrate into other parts of the body. This can cause serious problems and even death if the fractured piece migrates to the heart or lungs.
Despite awareness of these growing concerns about the blood clot filter, it appears, according to an NBC News report, that C.R. Bard hired a public-relations firm to avoid “unfavorable press” that could tank the company’s stock and reputation.
The public-relations firm circulated a confidential communications plan in 2004 that was obtained by NBC reporters. The plan detailed the deaths of two patients attributed to the migration of the Recovery blood clot filter.
“The proliferation of unfavorable press in top-tier media outlets can cause an onslaught of negative activity,” the PR firm stated in its communications plan, noting the potential for an onslaught of negative activity, that employee morale may suffer, stock prices might plummet, and reputations could be ruined. “Extensive preparation is critical to help prevent the spread of damaging coverage.”
Additionally, the NBC article states that C.R. Bard hired an independent doctor to study the Recovery blood clot filter. The study results showed that the Recovery filter exposed patients to a higher risk of death, fracture and migration than any other blood clot filters.
The investigator indicated in his report that “further investigation…is urgently warranted.”
However, instead of recalling the Recovery filter, C.R. Bard continued to sell more than 30,000 over the next three years.
C.R. Bard also faced hurdles to obtaining Food and Drug Administration approval for the Recovery blood clot filter, reports NBC. The FDA initially rejected the company’s application for the filter in 2002.
A regulatory consultant hired by Bard to help obtain approval raised red flags when she discovered that only a small clinical trial was used to vet the safety of the blood clot filter, but she says she was shut down when she told the company about her concerns, says the NBC report.
Blood Clot Filter Migration Symptoms
If you have been implanted with the Recovery filter and begin to experience any of the following symptoms, you should contact medical help immediately:
- Chest pain
- Shortness of breath
- Severe pain
- Cardiac/pericardial tamponade
As noted by the NBC reporters, your blood clot filter may have fractured and/or migrated. Pieces of the filter may be nearing your heart or lungs and could lead to severe complications and even death. Removal or a surgical intervention may be necessary to stop any problems.
If you have been implanted with a Recovery blood clot filter, consider contacting the experienced attorneys at McDonald Worley. The team of IVC filter lawyers will help protect your legal rights. Call today for a free case review.