Pharmaceutical company Johnson & Johnson (J&J) was ordered to pay $5.7 million to the plaintiff in its first trial related to injuries from TVT Abbrevo, a transvaginal mesh device. A California jury found the company liable for problems connected to the design of TVT Abbrevo. Additionally, the jury found that J&J failed to warn consumers of its risks.
According to Reuters, this verdict is the fourth win for plaintiffs suing J&J and its Ethicon Inc. unit for transvaginal mesh products. In total, more than 36,000 lawsuits have been filed against the company and its transvaginal mesh devices.
Abbrevo is one of Ethicon’s newer transvaginal mesh products and was approved by the U.S. Food and Drug Administration (FDA) in 2010. The device was approved to treat stress urinary incontinence.
Along with many other transvaginal mesh devices, however, Abbrevo has caused serious injuries among women, including erosion of the device through the vaginal epithelium and other parts of the body. This can cause intense pain and lasting negative effects.
Other transvaginal mesh complications include:
- Erosion through vaginal epithelium (the tissue inside the vagina)
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bowel, bladder and blood vessel perforation during insertion
- Vaginal scarring
- Mesh erosion causing discomfort, pain and/or dyspareunia (painful intercourse)
A total of seven companies are facing transvaginal mesh lawsuits filed by women and their loved ones who have been seriously injured.… Read the rest
Interested in the latest pharmaceutical news? Simmons Hanly Conroy’s pharmaceutical attorneys understand the importance of staying up to date, which is why we’re providing the list of recent news stories below. Read about U.S. Food and Drug Administration (FDA) recalls, approvals and warning label changes, medical studies and other pharmaceutical news that took place in the month of March.
- Drugs using testosterone will label heart risks
As mentioned by Simmons Hanly Conroy attorneys earlier this month, the FDA has ordered testosterone manufacturers to update the labels to include warnings of increased risk of heart attacks and strokes. The update also describes how testosterone should not be prescribed to treat symptoms in men brought about by natural aging.
- Statins increase risk of type 2 diabetes, study suggests
A new study discovered that statins (drugs used to lower blood cholesterol) increase risk of type 2 diabetes by 46 percent. Researchers found that this is a result of decreases in insulin sensitivity and secretion.
- FDA adds alcohol and seizure warnings to Pfizer’s quit-smoking pill
The popular smoking cessation drug Chantix now flaunts a new safety alert warning from the FDA. The label warns consumers about its risk of seizures and dangers of taking the drug with alcohol.
… Read the rest
Pelvic organ prolapse (POP), caused by the weakening of the tissues that hold pelvic organs, may be experienced by 30-50 percent of women. Despite its controversial results, transvaginal surgical mesh is the primary treatment for pelvic organ prolapse. Unfortunately, pelvic organ prolapse repair with surgical mesh can sometimes lead to complications and additional surgeries without much added benefit. Some of the transvaginal mesh (TVM) side effects include:
- Mesh erosion
- Organ perforation
- Urinary problems
Before pursuing transvaginal mesh lawsuits, patients should read about the precautions they can take to avoid dangerous complications, as recommended by the U.S. Food and Drug Administration (FDA).
- Ask About All of Your POP Options
Transvaginal mesh is not always the best option. In fact, a review of scientific research has shown that treatment of POP with surgical mesh repair does not decrease symptoms or improve the patient’s quality of life more than options without mesh. If your surgeon does insist on using mesh, make sure to understand his or her reasons for doing so.
- Practice Consistent Post-Surgery Care
Routine checkups and follow up care are vital to a healthy recovery from pelvic organ prolapse treatment. By staying aware of your body and keeping your doctors informed, you can catch surgical mesh side effects before they advance.
… Read the rest
Ovarian cancer is one of the most common cancers among women. According to the American Cancer Society, an average woman’s risk of developing ovarian cancer is 1 in 75. Approximately 21,290 women receive an ovarian cancer diagnosis every year.
However, there are certain risk factors that can increase a woman’s chances of developing ovarian cancer. Some of the risk factors are uncontrollable, while others can be avoided. Below is a short list of some of the most common ovarian cancer risk factors:
- Increased age
- Pregnancy after age 35
- Reproductive difficulties (never carrying a pregnancy to term)
- Fertility drugsAndrogens (male hormones)
- Estrogen therapy and hormone therapy
- Family and/or personal history of ovarian, breast or colorectal cancer
- High-fat diets
There is one ovarian cancer risk factor that many women may not know. Talcum powder, which can be found in baby powder, body and facial powders, deodorant powders and other cosmetic products, has been linked to an increased ovarian cancer risk. When applied directly to the genital area or on sanitary napkins, studies have shown that cancer-causing components from the powder may reach the ovaries.
Specifically, one study found a possible 30 percent increased risk of ovarian cancer with the perineal or genital use of talcum powder.… Read the rest
Testosterone therapy manufacturers must update the labels of all testosterone products to inform men about the increased risk of stroke, heart attack and death in patients taking testosterone, according to a testosterone safety announcement issued by the U.S. Food & Drug Administration (FDA) earlier this week.
“The benefit and safety of testosterone have not been established in men who have low testosterone levels for no reason other than age,” according to the FDA warning.
Between 2001 and 2011, The Journal of the American Medical Association reported that the use of hormones in men over 40 increased by almost 360 percent. This may have been due to an overwhelming amount of advertising about the inappropriate use of testosterone drugs, including consumer ads that promised aging men renewed vitality and strength.
A variety of factors can influence testosterone levels. However, testosterone therapy is only approved by the FDA for men who have low testosterone levels due to a disorder of the testicles, pituitary gland or brain that cause a condition called hypogonadism.
A recent FDA analysis showed that only about half of men taking testosterone therapy have been officially diagnosed with hypogonadism. This means many men are being prescribed hormones without a clear indication for its use, and are being unnecessarily put at risk for serious cardiovascular side effects.… Read the rest