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An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing. In particular, the group referenced a medical tool used in performing hysterectomies which, despite being widely available, has been found to contribute to the spread of cancer in patients.

This week, America's Health Insurance Plans, an organization representing nearly 1300 health insurers who provide coverage for over 200 million Americans, sent a letter to United States Senator Bob Casey, D-Pennsylvania, citing the dangers discovered regarding laparoscopic power morcellators. Since the 1990s, morcellators have been used to remove fibroids, or benign uterine growths, frequently during hysterectomies. Last year, the U.S. Food and Drug Administration (FDA) announced that women undergoing such procedures may be at higher risk for a certain type of malignant cancer, and use of the devices can potentially spread the cancerous tissue and worsen the condition.

While medical officials are reporting a significant drop in the use of power morcellators, they remain on the market. Johnson & Johnson, once the largest manufacturer of such devices, however, has withdrawn from the market.


It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted. The main issue with the device is that it was found to be subject to a high rate of corrosion at the neck junction.

In November of last year, an agreement was reached in New Jersey that determined that the manufacturer would pay an average of $300,000 per implant in individual lawsuits brought against it. In some cases, depending if the patient is deceased, the payout may be less. In other cases, in which the pain and suffering is determined to be extreme, the payout may be more. The company, in total, would payout $1.4 billion in settlement claims, though the claim must be filed by an individual patient, even in this mass tort case.

If you have experienced pain or suffering because of a Stryker hip implant, the first step is to seek legal counsel. The next is to enroll in the Settlement Program. Enrollment opened on January 16 of this year, and is open until March 2. If you do not enroll in the Settlement Program before March 2, you will not be eligible to receive compensation. The fact that you enrolled in the claims process, however, does not guarantee that you will receive payment either. If you did not register for the settlement by December of last year, it is possible that you are not eligible to enroll. If this is the case for you, it is imperative that you speak with an attorney right away.


A recent report shows the number of recalled medical devices continuing to increase. In response, many watchdog and consumer protection groups are aiming to make stricter requirements for medical devices.

A “cadre of insurers and other healthcare stakeholders” is urging the U.S. Food and Drug Administration (FDA) to “establish more registries to monitor and report performance” of medical devices being used in the U.S. market, according to MassDevice.com.

This cadre is requesting that the medtech registries be updated to enable more detailed information-gathering on devices that have been cleared or approved. Hence, this would help to ensure that complications resulting from the use or implementation of a faulty device would be recorded as soon as possible. This could help alleviate scenarios in which faulty medical devices are used, even after the first reports of failure.


Heart surgery and the implementation of a heart device are very serious procedures. According to the New York University Langone Medical Center coronary revascularization is one of the most risky heart procedures for patients; however, it is recommended for heart failure patients who have a varying degree of severity of heart problems.

Other types of risky heart procedures include septal myotomy and ventricular restoration. Septal myotomy is conducted to remedy a disease of “unknown origin that causes the heart muscle to thicken,” limiting the heart's ability to pump blood. Ventricular restoration is one of the most common as it is conducted to help restore the functions of a patient's heart after he or she suffers a heart attack.

In addition to these risky surgeries—all which carry a high risk in patient complications—there are a number of heart implant devices that also carry high risk. According to Medscape.com, a recent review of “cardiovascular device approvals in the U.S. suggests only a minority are ever tested against standard treatment” before they are approved for sale in the U.S.


Drug companies have attempted to capitalize on a market of men interested in improving their libido and life satisfaction with a treatment known as Low-T testosterone therapy. But that treatment is raising eyebrows from the FDA. With increased scrutiny surrounding defective medical devices and treatments amidst reports of heart problems from patients who have undergone the therapy, the FDA stands poised to evaluate the manufacturing companies.

Two studies about such therapies have already found that the treatment increases the risk of heart attack, stroke, and death. A patient contemplating receiving the therapy should fully investigate the claims from other patients and really consider whether it is worth taking on such a major risk.

Also, a healthcare professional should always be consulted before making the decision to undergo this kind of therapy, but even what seems like an informed decision can leave a patient seriously hurt.

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