Many medical patients have various heart problems that often require surgical intervention. Many medical devices are used to help patients with these issues. It is crucial that those devices are safe and do not present unreasonable risk of harm to patients. Yet, time and again stories are shared about devices which pose unnecessarily high risks.
St. Jude Heart Valve
For example, people implanted with St. Jude mechanical heart valves with Silzone-coated sewing cuffs (“Silzone valves”) may be at higher risk for paravalvular leak resulting in heart valve damage. For this reason on January 21, 2000, St. Jude Medical, Inc. instituted a recall of all Silzone valves that had not yet been implanted into patients.
There is also a concern that persons implanted with Silzone valves face higher risks of thrombus formation, thrombosis, and stroke. A thrombus is a blood clot that can form upon the valve, affecting its operation or even rendering it inoperable. Thrombosis is a condition in which blood clots form and then move through the blood stream. These clots can ultimately cause a transient ischemic attack (TIA) or a stroke due to thromboembolism.
Please visit the St. Jude Medical website for more information.
In November 1999, The Medical Device Agency in London issued a report entitled “Thromboembolic Complications involving Silzone Mechanical Heart Valves.” This bulletin reported a study in the United Kingdom of 51 patients implanted with Silzone valves. Seven of these patients, or 14%, suffered a stroke. Upon reviewing the data, the Society of Cardiothoracic Surgeons of Great Britain and Ireland confirmed that there is a greater thromboembolic event rate associated with Silzone valves compared to standard St. Jude mechanical heart valves. These results were presented at a recent meeting of the American Heart Association in Atlanta.
That study compared two groups of patients, 118 persons implanted with standard St. Jude valves and 75 patients implanted with Silzone valves. The data showed that persons implanted with the Silzone valves had much higher incidences of stroke and major embolism. The increase in incidence was greatest among patients implanted with either a mitral Silzone valve or both a mitral and aortic Silzone valve.
Securing Legal Aid for St. Jude Heart Valve Damage
If you or a loved one has suffered injury because of heart valve damage due to St. Jude’s silzone valves, call The Rothenberg Law Firm LLP at 1-800-624-8888 or submit an InjuryLawyer.com online case evaluation. The initial consultation is FREE of charge. If we agree to handle your case, we work on a contingency fee basis. Meaning we get paid for our services only if there is a monetary recovery of funds.
In many cases a lawsuit must be filed before an applicable expiration date, known as the Statute of Limitations. It is important, therefore, to call right away to ensure that you are not waiving your right to possible compensation.