FDA Warns Vaginal Mesh Risks Outweigh Benefits

Vaginal Mesh is a medical device that is surgically implanted used to treat pelvic organ prolapse, a condition that occurs when pelvic organs, such as the bladder, uterus or rectum, slip out of place. The FDA has issued a warning stating that the benefits do not outweigh the risks associated. Vaginal Mesh Side effects include vaginal pain, infections, pelvic organ prolapse re-occurrence, or vaginal mesh erosion, where the mesh erodes into neighboring organs. Vaginal Mesh is difficult to remove once inserted.

Vaginal Mesh Approved by Controversial Process

The FDA's controversial 501(k) process has been responsible for approving close to 90 percent of vaginal mesh products on the market. Rather than undergoing a tough approval process, vaginal mesh manufacturers only need to show that their product is similar to an item currently on the market, which is known as a predicate device.

However, if the predicate device is recalled or voluntarily removed from the market, the additional devices are not removed. In fact, they may be used as predicate devices to approve additional products. Several vaginal mesh predicates have been removed from market because they have been linked to harmful side effects, including pain, mesh erosion or mesh shrinkage.

House Democrats Seek Vaginal Mesh Hearings

House Democrats have urged the House and Energy Commerce Committee to investigate claims of injury and harm caused by vaginal mesh surgical products. The investigation will require vaginal mesh manufacturers to provide documents about the medical devices.

This is in addition to a letter the FDA sent to 33 vaginal mesh manufacturers requiring them to conduct additional safety studies over the course of the next three years to determine the safety and effectiveness of the device.

Mesothelioma Symptoms Increasingly Important to Recognize

Between 1940 and 1979, it is estimated that 27.5 million people were occupationally exposed to asbestos in the United States. As a result, it is increasingly important that doctors and patients be able to recognize the symptoms of mesothelioma, a form of lung cancer that is nearly always associated with exposure to asbestos. What can make mesothelioma so dangerous is the fact that it is one of the most deadly forms of lung cancer, combined with the fact that it can be so often misdiagnosed as a less serious lung malady.

Yasmin Linked Alleged Gallbladder Disease

Yasmin, Yaz and the generic Ocella birth control pills have been linked to potentially fatal health issues including heart attacks, strokes, pulmonary embolism and gallbladder disease. One of the main ingredients, drospirenone, may be responsible for the increased cardiovascular risk, as it has been linked to an increase in potassium levels in the blood. Although Bayer has upheld the safety of the drugs, several Yasmin lawsuits have been filed nationwide.

Fixodent Blamed for Zinc Poisoning

Fixodent, a leading denture cream, has been linked to several reports claiming the adhesive is responsible for zinc poisoning, which can result in liver problems, kidney failure, neurological problems and other serious side effects. Some reports have indicated that the side effects can be premanent. Fixodent lawsuits have been filed alleging that Proctor and Gamble, the company that makes Fixodent, was aware that the product could be dangerous, but did not properly warn consumers. P&G has maintained that the product is safe to use as directed.

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