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In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It's the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes. The system consists of a rechargeable electrical pulse generator, leads, and electrodes that are implanted surgically into the abdomen. Safety trials consisted of 233 patients, in which 157 received the device and 76 in a control group who did not. Though there were some adverse effects observed, the FDA sponsored a survey that found that patients with severe obesity would be willing to accept the dangers for the weight loss it promised.

There are several devices to help fight obesity that have been on the market for years, including those that tie off the passageways to the stomach. Some of these devices require that the patient eat very slowly, or that he takes very small bites. Many of these devices came under fire by the FDA for safety concerns. One well-publicized event was the discontinuation of the manufacture of one of these devices for teenagers after two percent of patients who were using them experienced severe side effects. According to the National Institutes of Health, a significant number of patients surveyed in a trial of obesity-reducing devices experienced negative side effects.

Only time will tell if the recently approved device will have a similarly bad track record. If you or someone you know has experienced negative side effects or long-term health problems because of an obesity device, you may be eligible for compensation. Do not go through it alone. Contact an experienced Chicago defective medical device attorney today.

In what will likely be the first of many settlements to come, Johnson & Johnson has agreed to resolve claims from four Missouri women that its Ethicon Prolift vaginal mesh implant caused serious injuries.

The settlements came almost literally at the courthouse door, as jury selection was scheduled to begin in late January 2015. Since the controversy over these devices began in 2012, J&J consistently denied that these devices are dangerous. Nevertheless, it currently faces about 23,000 liability lawsuits. One observer noted that “it's only four cases, but it's a start. There's still a long way to go to get the whole thing resolved.” A J&J spokesperson emphasized that the company did not admit or deny liability as part of the settlement terms and that “the company may consider whether settlement is appropriate” in individual cases.

Johnson and Johnson voluntarily recalled the Ethicon Prolift in June 2012, along with three other vaginal mesh implants. Other manufacturers include Boston Scientific, American Medical Systems and Coloplast.

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Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant designed to strengthen a weakened vaginal wall in the instance of POP or to reinforce the urethra to treat SUI. In 2011, the FDA issued a follow-up of its health notification from three years previous, which alerted people to the complications linked to transvaginal mesh when treating either of these medical conditions.

The updated safety alert identified additional concerns and growing numbers of reported difficulties involving surgical mesh devices. From the time between the initial communication in 2008 through to the end of 2010, the FDA recognized that complications were continuing at a high rate and were not considered a rare occurrence. More than 1,500 additional cases involving transvaginal mesh for POP repairs were documented and nearly 1,400 reports were linked to repairs for urinary continence.

According to The Harvard Medical School, over 1 in every 10 women will undergo prolapse surgery by the time they turn 80 years of age. Prolapse may be discovered during regular pelvic exams or carry symptoms including:

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With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition. There are several types of biopsies, according to WebMD. A surgical biopsy is one of the most common, and one of the most dangerous. In a surgical biopsy, a surgeon will either remove a part of tissue or a whole lump of tissue.

Because of the sensitive nature of biopsies, especially in cases in which a patient may already be ill or injured, equipment used in the procedure must be painstakingly considered. When biopsy medical devices are recalled, it can be a very serious issue for any patient involved. One such recall issued in 2011 just recently expired, but not before implicating thousands of patients. In 2011, DeRoyal Industries, based in Tennessee, issued a recall of their Geomed Biopsy Tray, an all-inclusive tool kit used by surgeons to perform the invasive procedure. According to the U.S. Food and Drug Administration, there were several products included in the tray that were potentially contaminated, including triad lubricating jelly, alcohol prep pads, and alcohol swabs.

According to the Committee to Reduce Infection Deaths (RID), Center for Disease Control data suggests that 1.7 million people contract infections in U.S. hospitals every year. The RID posits that number is actually seven times higher than that. Contamination from faulty medical equipment, such as the recalled biopsy tray, is one major culprit of such infection. Medical equipment that is not sterilized properly can not only transmit infection borne at the manufacturing site, but also obtained at the hospital itself.

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An international group of scientists recently condemned Metal-on-Metal hip replacement implants. A report issued by the European Commission's Scientific Committee on Emerging Newly Identified Health Risks concluded that metal-on-metal (MoM) devices should be “avoided” due to their “high failure rate.” Researchers stated that MoMs should be used only on a case-by-case basis, in light of other, more effective available alternatives. For those patients who had already received these devices, the report recommended ongoing followup visits with the surgeon, especially in the first five years when the devices are most prone to failure.

The 14-member SCENIHR is based in Luxembourg. Ten noted experts from Western and Central Europe contributed to the report.

Metal-on-Metal Hip Implant Lawsuits

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