Cardiology

Medical manufacturers reap great financial profits from successful medical products and have a responsibility to ensure that medical devices are safe and effective. Unfortunately, too many medical devices have injured unsuspecting and innocent consumers.

An unsafe medical device can be anything from an ineffective heart valve to a curette that is not adequately sterilized.

• CYPHER stents designed to slowly release a drug which helps to reduce the rate of re-blockage(blood clots, pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes );
• Various heart valve implants (leakage and strut fractures caused repeated surgeries or heart failure);
• Pacemakers (stopped or failed to keep proper heart rhythm, posing a threat to life);

The Lawrence E. Feldman & Associates have been representing people who suffer injuries caused by dangerous or mislabeled products. Our firm often finds experts who recommend doctor administered prevention programs to the court to help monitor users who are at greater risk because of exposure to the product.

Cosmetic surgery

Cosmetic surgery defective medical devices are penile, breast and chin implants. If defective or improperly implanted, these devices can lead to complications, infection, pain and medical problems.

Because medical devices are usually introduced to patients through their doctors, there is often no direct contact between the patient and the medical device manufacturer. In such cases, the obligation to warn the patient about the potential risks and complications associated with the use of a medical becomes the responsibility of the physician, who must pass on to the patient the information that he receives from the manufacturer.

The Lawrence E. Feldman & Associates have been representing people who suffer injuries caused by dangerous or mislabeled products. Our firm often finds experts who recommend doctor administered prevention programs to the court to help monitor users who are at greater risk because of exposure to the product.

Cypher Coronary Stent

The FDA warned that Johnson & Johnson's newest heart device, the drug coated Cypher Stent, has been linked to hundreds of cases of blood clots and said the the device has been linked to more than 60 deaths.

The FDA approved the Cypher Stent earlier this year for angioplasty procedures to open clogged coronary arteries. In most cases, a stent is left permanently in the artery to keep the vessel open after angioplasty. The Cypher stent stent is designed to slowly release a drug which helps to reduce the rate of re-blockage that occurs with existing stents.

Each year 800,000 angioplasty procedures are performed in the United States to open clogged coronary arteries. In approximately 15%-30% of patients, the artery becomes clogged again (a condition called restenosis) within a year, and it must be treated again with a procedure such as angioplasty or bypass surgery.

This warning was the second warning sent to doctors since the launch of the Cypher stent in April 2003. The FDA said Johnson & Johnson's drug-coated stent, a tiny wire mesh device used to prop open surgically cleared arteries and deliver medicine to keep them open, resulted in more than 290 cases of blood clots among patients 30 days after receiving the device.

The FDA also said that the defective Cypher stent was associated with other serious injuries that required medical or surgical intervention including more than 50 reports, including some deaths, that J&J considers to be possible hypersensitivity allergic reactions. The symptoms include pain, rash, respiratory alterations, hives, itching, fever and blood pressure changes.

FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents
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11/03/03 - The Food and Drug Administration (FDA) today informed physicians about adverse events associated with Cordis Corporation's Cypher Coronary Stent. FDA posted the information on its web site as a public health notification to physicians.

FDA has received more than 290 reports of thrombosis (clotting) occurring one to 30 days after the procedure to implant the device. In more than 60 of these reports, use of the device was associated with the death of the patient; in the remainder, the device was associated with injury requiring medical or surgical intervention.

FDA has also received more than 50 reports, including some deaths, that Cordis considers to be possible hypersensitivity reactions. The symptoms include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.

Hundreds of thousands of patients have been successfully treated with the Cypher stent. FDA does not have enough information to determine whether the incidents of thrombosis and hypersensitivity reaction with the Cypher stent differs from those experienced with bare metal stents.

FDA approved the Cypher stent in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. The stent, a cylindrical metal mesh, is designed to keep the arteries from re-clogging after the procedure. It is coated with a thin polymer containing the drug sirolimus that is slowly released into the patient and is intended to reduce the rate of re-blockage that occurs with other stents.

The cause of these adverse events has not yet been determined. FDA and Cordis are working quickly to gather as much information as possible about the circumstances surrounding these events. FDA is also working with the regulatory bodies of other countries to get more information about foreign experience with the Cypher stent.

Until FDA gets to the root of the problems, the agency is encouraging doctors to follow the instructions for use of the stent, and urging them to be vigilant for any patient symptom that may be attributed to hypersensitivity.

Patients who have received this stent should continue to follow their regularly scheduled plan for follow-up appointments with their doctor.

As a condition of approval, FDA is requiring Cordis to conduct a 2000-patient post-approval study and continue evaluating patients from ongoing clinical trials to assess the long-term safety and effectiveness of the stent and to look for rare adverse events that may result from use of the product.

Doctors and patients who have experienced an adverse event related to the stent are encouraged to report the incident to the FDA

St. Gobain Ceramic Hip Implants

The component, a zirconia ceramic femoral head, was recalled by its French manufacturer St. Gobain Desmarquest on August 14, 2001 because it fractured at a higher rate than expected in some patients 13 to 27 months after being implanted. The component is the ball portion of the hip prosthesis that connects the femoral stem to the pelvis. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopedic industry.

U.S. companies estimate that hip implants with zirconia ceramic femoral heads are used in less than six percent of hip implant procedures in the United States. An estimated 150,000 to 200,0000 hip implants are performed annually in the United States.

Patients who already have these hip implants should contact their surgeons with any questions or concerns. Not all zirconia ceramic femoral heads are expected to fail, and not all patients will experience a problem; therefore, the Food and Drug Administration (FDA) is not recommending surgery to replace hip implants that have not fractured or are not causing problems. Physicians will likely choose to monitor the performance of the implant more closely as a result of the potential problem.

The Lawrence E. Feldman & Associates have been representing people who suffer injuries caused by dangerous or mislabeled products. Our firm often finds experts who recommend doctor administered prevention programs to the court to help monitor users who are at greater risk because of exposure to the product.