Articles Posted in Health & Wellness

Zimmer Biomet Reverse Shoulder Product Recall

Shoulder replacement surgeries are common and provide relief to thousands. But some conventional shoulder replacement surgeries don’t work, requiring a different type of shoulder replacement surgery.

In a typical shoulder replacement, artificial components replace natural ones, such that an artificial cup is placed into the shoulder while an artificial ball is placed at the top of the humerus, or arm bone. For individuals with rotator cuff tears and arthropathy, which is a complex type of shoulder arthritis, this type of shoulder replacement surgery doesn’t work.

Instead, patients must obtain a reverse shoulder replacement, which places the ball in the shoulder and the cup at the top of the humerus. One such reverse shoulder replacement medical device is Zimmer Biomet’s Comprehensive Reverse Shoulder System. However, this product has recently been recalled by Zimmer Biomet.

The Reverse Shoulder Recall

Zimmer Biomet Reverse Shoulder RecallOn December 15, 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder System, noting that it was fracturing far more often than expected and could lead to serious problems, such as infection, inability to use the shoulder and even death. Fracturing is an unusual problem, since most shoulder replacement complications do not involve fracturing, but instead deal with excessive wear, dislocating and loosening of joint components.

Due to the severity of the problem with the Comprehensive Reverse Shoulder System, the U.S. Food Drug and Administration (FDA) classified this recall as a Class I recall, which is the most serious type of recall available.

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Female contraception is common these days, with many medications, medical devices and methods available. One popular birth control method is the intrauterine device, or IUD.

There are many companies making different types of IUDs that work in different ways. Some use copper as the primary means of contraception while others use hormones. One of the most popular hormonal IUDs available goes by the brand name Mirena.

How Does the Mirena IUD Work?

Mirena is a hormonal IUD that is inserted into a woman’s uterus. Once inserted, the IUD continuously releases a small amount of the hormone levonorgesterel. The Mirena IUD is extremely effective and works primarily by preventing fertilization from occurring, rather than preventing implantation of the fertilized egg into the uterus.

Another advantage of the Mirena IUD is that it works for a long period of time (three to five years) without any intervention by the woman. And when the effective time period of Mirena passes or the woman decides she wants to try to get pregnant, the Mirena IUD can be removed and fertility restored. Because of these advantages, many women have chosen Mirena as their preferred form of birth control.

What’s Wrong with the Mirena IUD?

Woman with Mirena IUD Suffering from Intracranial HypertensionDespite its effectiveness as a contraceptive and its popularity, the Mirena IUD has caused some women to suffer from a variety of serious conditions, including the dangerous buildup of cerebrospinal fluid in the brain. This fluid buildup then causes an increase in intracranial pressure and can lead to severe headaches, ringing in the ears, nausea, blurred vision, neck pain, and blindness due to the swelling of the optic nerve.

Many women experience progressively worsening vision as the optic nerve swelling increases. Most of these symptoms are similar to those people suffering from a brain tumor. There are several names to describe this condition, including Pseudotumor Cerebri (PTC) and Intracranial Hypertension (IH).

Depending on the woman, the effects of PTC or IH can sometimes be reversed, but it often results in permanent damage to a woman’s vision. Even if the effects can be reversed, it usually takes years of maintaining normal intracranial pressure in the brain. As a result of these problems, many lawsuits against Bayer, the maker of Mirena, have recently emerged.

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Smoking Can Harm Product Liability CaseFirst, let me make the case for smoking:

You enjoy it. It tastes good (I guess). It makes you alert (I hear); but also, oddly, it can calm you as well (from what I’ve read). You also look cool doing it (I confess; this last part is often true). And it’s legal. But perhaps the strongest argument I hear from smokers is this: no one is going to tell me I can’t smoke. This is a free country after all.

That’s about it, really. That’s all I’ve got. And I’m not here to nag you. By all means, smoke if you must. But let me present a different perspective: setting aside the many health problems smoking causes, it can also destroy or damage your product liability or personal injury case.

I will publish a new book this week: Product Liability Law: Litigation, Settlement, and Wellness.

Product Liability Law CoverThe book offers concise chapters on issues you need to be aware of when you first discover that a medical device may have failed in your body, or when a prescription medication is beginning to cause dreadful side effects. Beyond that, I discuss issues that arise when you are involved in product liability litigation, as well as concerns about money: before a product liability lawsuit is filed, during product litigation, and after a product lawsuit is resolved.

If you would like a free copy of Product Liability Law, I ask that you subscribe to the website. It takes twenty seconds to sign up. You will receive a copy of Product Liability Law, and you will receive emails only when I post new articles to the site. Two emails a week, tops.

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Viagra May Cause CancerAs if erectile dysfunction were not harrowing enough. In March 2016 a published study concluded that the use of the drug sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) “could promote melanoma in humans.”

As you probably know, melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells (usually caused by ultraviolet radiation from sunshine or tanning beds) triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Most people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma is often caused by intense, sustained exposure to ultraviolet light, the kind which causes suntans and sunburns. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The Latest Study

Exercise and Medical Device Failures

I was reading an article about the latest study touting the benefits of exercise. It was stunning. The study involved analyzing the brains of two groups of mice: one group in a cage with an exercise wheel; the other in a cage without the wheel. Researchers watched the mice for four weeks. Predictably, the mice with the exercise wheel exercised; the mice without the wheel did not. After a month the scientists measured brain activity in both groups.

Turns out, running and other forms of exercise produce a protein in the brain called “brain-derived neurotropic factor” or BDNF (I feel smarter just writing that name). This stuff is very good for your brain. BDNF promotes the growth and vigor of neurons. BDNF has also been shown to strengthen the synapses that connect neurons, which allows the brain to function better. Low levels of BDNF has caused cognitive decline in people and animals. Exercise increases levels of BDNF in the brain.

Exercise Promotes BDNF and Ketones

In the study scientists discovered that in the brains of mice who exercised regularly, a molecule which blocked the growth of BDNF was less effective. As a result, much more BDNF was produced in the mice who exercised. Sadly but predictably, less BDNF was produced in the sedentary mice. Researchers also found that the exercising mice produced ketones which make their way to the brain and fight off the bad molecules and further promote the growth of BDNF. The guy who directed the study, NYU professor Moses Chao, said: “It’s incredible just how pervasive and complex the effects of exercise are on the brain.”

You can check out the new study here. It’s the latest in a long line of studies which prove time and again that exercise is vital to your health. Seriously, people have to exercise. Not exercising causes all kinds of physical and mental problems.

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We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.
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