FDA panel recommends limited use of Bayer’s Essure until more is known about safety

An FDA advisory panel yesterday recommended that the agency limit the use of Bayer‘s (ETR:BAYN) Essure female sterilization device until more is known about its safety, after thousands of women reported serious health issues they attribute to the nickel-titanium implant. Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002. In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking. Those adverse event reports include 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons such as infection and uterine perforation, the FDA said. In a report issued before yesterday’s meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel, the agency said it logged a nearly 1,400% spike in complaints filed over Essure in the last 3 years. Yesterday a Bayer’s director of global pharmacovigilance risk management, Dr. Andrea Machlitt, told the panel that it’s received 17,000 adverse event reports, 15,000 of which involved U.S. patients. Yesterday the 16-member panel agreed that the device shouldn’t be used in women with metal allergies, autoimmune disease,...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer HealthCare Obstetrics and Gynecology Devices Advisory Panel Source Type: news

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2019 has become the year when antiabortion politicians make clear that their ultimate agenda is banning abortion outright, at any stage in pregnancy and for any reason.
Source: The Guttmacher Institute - Category: International Medicine & Public Health Authors: Source Type: news
Ulnar-sided carpometacarpal (CMC) joint fracture dislocations are relatively uncommon, frequently associated with fractures of the metacarpal base and/or hamate, and often sustained by young male individuals secondary to striking a hard object. The complexity of ulnar-sided CMC fracture dislocations necessitates careful restitution of anatomic alignment and joint congruency for mobility and stability. Miniaturization of the external fixation device has allowed application to the hand. Spanning external fixation utilizes the principles of “ligamentotaxis”—indirect reduction through distraction forces of ca...
Source: Techniques in Hand and Upper Extremity Surgery - Category: Surgery Tags: Techniques Source Type: research
So my MCAT was logged in for May 31st, but my genius self decided to play basketball yesterday and rolled my ankle yesterday. I have a fracture in the tarsal dome and my ankle is bruised up and swollen like a ball so I'm guessing ligament damage as well. I am in a lot of pain and can't even concentrate on studying because of my foot, I was thinking of moving my test to June 15th just to give me time to readjust. Would this be to late for the cycle? Any help appreciated!!
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pre-Medical - MD Source Type: forums
Lisfranc ligament injuries are not so common and often overlooked. If missed, they can cause long-term disability and pain. The treatment of these injuries are still controversial and very little is known about which types of injury can be treated without surgery. Successful surgical management of these injuries is predicated on anatomic reduction and stable fixation. Open reduction and internal fixation remains the standard treatment, although ligament reconstruction has emerged as a viable option for certain types of tarsometatarsal joint injuries. This paper describes the authors’ approach to treat Lisfranc’...
Source: Techniques in Foot and Ankle Surgery - Category: Orthopaedics Tags: Special Focus: Innovations in Foot and Ankle Sports Injury Treatment Source Type: research
Ankle sprains are one of the most common injuries in foot and ankle, and the superior fascicle of the anterior talofibular ligament (ATFL) frequently is injured as a consequence. Patients with isolated rupture of ATFL’s superior fascicle can sustain a subtle ankle instability or ankle microinstability. Patients with symptomatic ankle microinstability may describe a subjective feeling of ankle instability, recurrent symptomatic ankle sprains, chronic anterolateral pain or a combination of any of them. When conservative management fails, anatomic all-inside ATFL’s superior fascicle repair under direct arthroscopi...
Source: Techniques in Foot and Ankle Surgery - Category: Orthopaedics Tags: Special Focus: Innovations in Foot and Ankle Sports Injury Treatment Source Type: research
Allograft reconstruction of chronic peroneal tendon tears is a safe and effective option to help restore patient function and limit pain. Both the author’s experience, along with cadaveric and clinical studies, have shown that this technique can restore function and stability. The authors provide step-by-step instruction of their preferred allograft reconstruction technique for chronic peroneal attritional injuries, while limiting the comorbidities that may be seen with autograft reconstruction. Level of Evidence: Level IV—review article, expert opinion, operative technique.
Source: Techniques in Foot and Ankle Surgery - Category: Orthopaedics Tags: Special Focus: Innovations in Foot and Ankle Sports Injury Treatment Source Type: research
More than a dozen surgical techniques have been described for management of avascular necrosis or traumatic loss of large portions of the talus. The smaller the area of necrosis, the better the outcomes. Procedures to induce revascularization (core decompression/drilling, vascularized bone grafts) have been reported with variable success. Patients with avascular necrosis of large portions of the talus present unique treatment difficulties. These techniques largely focus on pantalar or tibiotalar-calcaneal arthrodesis with large bone blocks. These surgeries eliminate motion, lead to high levels of patient dissatisfaction, a...
Source: Techniques in Foot and Ankle Surgery - Category: Orthopaedics Tags: Technique Source Type: research
LUNG cancer symptoms include having a cough that won ’t go away, chest pain, and difficulty breathing. But you could also be at risk of a tumour if you have any of these “unusual” signs. Should you speak to a doctor?
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
POLLEN COUNT UK forecast: Hay fever patients could be at risk of unwanted allergy symptoms today , the Met Office has revealed. These are the signs and symptoms of hay fever to watch out for.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Authors: Robak E, Gerlicz-Kowalczuk Z, Dziankowska-Bartkowiak B, Wozniacka A, Bogaczewicz J Abstract Introduction: Immune system activation, microvascular abnormalities and extracellular matrix deposition in tissues play roles in systemic sclerosis (SSc). Th17 cells producing interleukin (IL)-17 are involved in the pathogenesis of many autoimmune-mediated inflammatory diseases; however, the role of IL-17 in SSc remains unclear. Material and methods: The concentrations of IL-17A, IL-17B, IL-17E, and IL-17F in the serum of patients with SSc and in the healthy control group were assessed with regard to type of the...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
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