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Los Angeles Defective Drugs Law Blog

Medical devices part of food and drug's latest recent safety act

Two years ago, Congress turned the Food and Drug Administration Safety and Innovation Act into law. Now, regulators with the administration want to know if there is more the Food and Drug Administration can do. For the uninitiated, the FDASIA was developed to contain patient-centered provisions that would hopefully impact the FDA in a positive way by facilitating big changes to regulation attempts.

Two programs under the FDASIA have the potential to create the most powerful changes. They are the Patient-Focused Drug Development program and the Patient Preference Initiative regarding medical devices. The first arose out of concern that the FDA regulated products for conditions or diseases with few treatment options too stringently. The second program's purpose centers on adopting patient-focused techniques to medical device regulation much in the same way the FDA regulates drugs.

Mirena defects and other issues with birth control

Women in California turn to birth control devices and expect them to work. They also have a right to avoid injury while using these products. However, this is unfortunately not always the case. Many different types of products have been known to cause injuries or health issues, and it is very important for women to know all about these -- especially if they have already used the products.

For example, some Mirena defects have led to issues like pelvic inflammatory disease and infertility. Some people have also reported infections with this IUD, and these infections can lead to a whole string of health problems on their own.

How recalls are linked to spending and the economy in California

Some reports have stated that recalls on consumer products are incredibly prevalent now, to the point that some consumers are worried about it. One report in Forbes even called it the "Decade of the Recall."

While this does show the overall trend, one important thing to look at is the way that recalls can be linked to the economy and to spending. For example, when the recession hit the United States, recalls on consumer goods actually dropped. However, recalls on food and similar items did not see the same slump. Why was this?

2 studies claim Food and Drug Administraion putting lives at risk

The latest issue of JAMA Internal Medicine contains two studies that provide additional information and evidence that the U.S. Food and Drug Administration isn't ensuring the safety of medical devices for Californians and others before they are approved.

The first study, completed by the National Center for Health Research, examined 50 implantable medical devices including bladder slings and hip replacements. These devices were approved under the FDA's 510(k) program. That program allows device manufacturers to simply present evidence that other similar medical devices have already gained approval. That would be enough for the new device to get approval as well.

How are defective medical devices recalled?

If you have been injured or had a loved one die because of a medical device you believe is defective, what is your next step? Did you know that the U.S. Food and Drug Administration is responsible for recalling defective medical devices when the company refuses to do so? Here is how such a product is recalled and some of the reasons that a recall is needed.

How a defective medical device is recalled:

FDA Approves Expanded Use Of Blood-Clot-Busting Drug

A recent Reuters report tells us that the FDA has approved the use of a pharmaceutical drug called Eliquis for the treatment of blood clots ("FDA approves use of Eliquis to treat leg, lung clots").

Specifically, the FDA has approved an "expanded use" for Eliquis.

Previously, Eliquis was approved only for treating atrial fibrillation, or irregular heartbeat, which can cause strokes. The expanded approval includes treatment for blood clots in the legs and lungs, known as deep vein thrombosis and pulmonary embolism, respectively.

Johnson & Johnson Recalls Hysterectomy Power Morcellators

Not long after Jennifer Levitz for the Wall Street Journal reported that gynecologist Andrew Brill stepped down from his position as adviser to the U.S. government regarding the safety of the hysterectomy power morcellator, a medical study published in the Journal of the American Medical Association seems to have pushed Johnson & Johnson to recalling the device.

Report: 1 In 5 Prescriptions Written For Unapproved Use

The Washington Post reports that "off-label" use of prescription drugs in patients is significant ("Consumers should be wary when a doctor prescribes a drug for 'off-label' treatment"). That's not to say that doctors are necessarily wrong by default if they prescribe a drug to a patient for off-label use, but the point is that prescription drugs aren't completely safe-no drug is completely safe-which can put some patients at risk.

A Medical Device That Spreads Cancer In Women

It's not unusual for money to get in the way of science.

Jennifer Levitz for the Wall Street Journal reports that San Francisco gynecologist Andrew Brill stepped down from his position as adviser to the U.S. government regarding the safety of a medical device known as a laparoscopic power morcellator.

Fecal Transplants: The 'Miraculous' Treatment For Infectious Diarrhea

The superbug Clostridium difficile, or C. diff, is an infectious diarrhea that causes roughly 15,000 deaths in the U.S. every year, and sickens roughly 500,000. As Matthew Perrone with the Associated Press reports, patients on the verge of death, who remain uncured by antibiotics, may turn to what Perrone characterizes as "a low-cost treatment for a life-threatening infection that could cure up to 90 percent of patients with minimal side effects."

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