UPDATE: FDA mandates new study, ‘black box’ label for Bayer’s Essure

Updated with comment from Bayer The FDA today said it would put a pair of measures in place for the controversial Essure permanent contraception device made by Bayer (ETR:BAYN), mandating a new clinical study and new guidance on using the device. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said. Earlier this month an analyst who examined the FDA’s adverse events website for cases involving the Essure device said the federal safety watchdog likely underestimated the number of fetal deaths linked to the implant. Today the FDA said it would require Bayer to run a new trial designed to “determine heightened risks for particular women” and draft guidance including a boxed warning label explaining the potential for adverse events connected with Essure. Bayer must design and conduct the post-market surveillance study comparing Essure with laparoscopic tubal ligation, the FDA said, using measures such as rates of complications including unplanned pregnancy, pelvic pain and other symptoms, explantation surgery and a...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer HealthCare Source Type: news

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Hormonal changes have been implicated in the phenomenon of pain modulation during pregnancy. The role of psychosocial constructs such as fear and anxiety related to pain during pregnancy, however, has largely been overlooked. The current study investigated the cross-sectional associations between the report of pain-related fear among pregnant and non-pregnant female participants. The study consisted of three different convenience samples: pregnant females (N=1171; age: M=28.61, SD=5.3), non-pregnant female undergraduate students (N=274; age M=19.81, SD=3.9), and non-pregnant female patients (N=212) diagnosed with chronic p...
Source: The Journal of Pain - Category: Materials Science Authors: Source Type: research
We present the case of a 35-year-old female at 25-week gestational age with new onset severe low back and right leg pain. The patient had a history of prior lumbar laminectomy and discectomy for similar symptoms. She presented after failed conservative management with gabapentin and acetaminophen and the pain began to interfere with her daily activities.
Source: The Journal of Pain - Category: Materials Science Authors: Source Type: research
This article provides an overview of the latest techniques and devices used for uterine-sparing surgical treatment of fibroids. While laparoscopic myomectomy is still the gold standard, novel laparoscopic and transcervical radiofrequency ablation techniques use low-voltage and alternating current to induce heat in the uterine tissue, which triggers necrosis in fibroids. This enables the removal of multiple fibroids without the need for large incisions in the uterine wall. In addition, we address the benefits and potential risks, as well as the impact on fertility and pregnancy, of the different surgical approaches used for...
Source: Surgical Technology International - Category: Surgery Tags: Surg Technol Int Source Type: research
A shocking watchdog report alleges that the U.S. Department of Agriculture (USDA) spent $22.5 million conducting “unnecessary and unjustifiable” research that involved killing cats and forcing “kitten cannibalism,” among other unsavory practices. The report — from the non-profit White Coat Waste Project, which opposes animal testing by the government, and former USDA scientist Jim Keen — says a large chunk of this research relates to toxoplasmosis, an illness spread by exposure to the Toxoplasma gondii parasite. As recently as 2015, the report says, the USDA purchased and killed cats and...
Source: TIME: Science - Category: Science Authors: Tags: Uncategorized onetime Research Source Type: news
Sibling comparison analysis suggested association confounded by specific maternal factors
Source: Pulmonary Medicine News - Doctors Lounge - Category: Respiratory Medicine Tags: Family Medicine, Gynecology, Neurology, Nursing, Pediatrics, Pulmonology, Anesthesiology & amp; Pain, Allergy, Journal, Source Type: news
Stomach pain is one of the most common pregnancy complaints. Most often, pain in the upper stomach or abdomen is harmless, though people should know when to see a doctor. Learn more about the causes and treatment for upper abdominal pain during pregnancy here.
Source: Health News from Medical News Today - Category: Consumer Health News Tags: Pregnancy / Obstetrics Source Type: news
CONCLUSIONS: Our study suggests that there is an increased incidence of antenatal complications in women with pelvic pain and/or vaginal bleeding in the first trimester. This should be considered when advising women attending early pregnancy units. This article is protected by copyright. All rights reserved. PMID: 30887596 [PubMed - as supplied by publisher]
Source: The Ultrasound Review of Obstetrics and Gynecology - Category: Radiology Authors: Tags: Ultrasound Obstet Gynecol Source Type: research
AbstractPregnancy can be seen as a positive time for women migraineurs because the elevated estrogen and endogenous opioid levels raise the pain threshold and the stable hormone levels, which no longer fluctuate, eliminate a major trigger factor for the attacks. In a great majority of cases, indeed, migraine symptoms spontaneously improve throughout pregnancy. Generally, migraine without aura (MO) improves better than migraine with aura (MA), which can occur ex novo in pregnancy more frequently than MO. After childbirth, the recurrence rate of migraine attacks increases, especially during the first month; breastfeeding exe...
Source: Neurological Sciences - Category: Neurology Source Type: research
ConclusionsUrethral diverticula should be excluded whenever a patient exhibits unresolved, nonspecific urinary problems. This is an underdiagnosed problem. Pregnancy presents additional challenges, but does not preclude medical or surgical treatment in the patient with significant symptoms.
Source: International Urogynecology Journal - Category: OBGYN Source Type: research
Acute fatty liver of pregnancy is one of the most common causes of fulminant hepatic failure. A 28-year-old G3P1L1A1 presented at 37 weeks with diagnosis of acute fatty liver of pregnancy with grade 3 hepatic encephalopathy. Laboratory findings were suggestive of coagulopathy, metabolic acidosis, and liver and renal dysfunction. Ultrasound-guided transversus abdominis plane block with ilioinguinal–iliohypogastric nerve block is widely used for postoperative analgesia. We applied these blocks, supplemented with intravenous ketamine for breakthrough visceral pain, to conduct cesarean delivery with a favorable outcome. ...
Source: A&A Case Reports - Category: Anesthesiology Tags: Case Reports Source Type: research
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