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infections 92 articles

Researchers credit increase in IUD use for a decrease in abortions

An increase in the number of women using intrauterine devices, or IUDs, for birth control may be credited for a drop in the number of abortions, a new study reports. The rate of abortions has dropped steadily in the past 20 years from about 19.4 per 1,000 women ages 15 to 44 in 1991 to a rate of 16.9 percent per 1,000 women, and there was a 13 percent drop since 2008. Lawmakers may boast state laws restrict abortion but researchers with Guttmacher Institute, a reproductive-health research organization, say there is “no evidence” to support that assumption. After all, most ... Read More

3 medical devices that can harm you

Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good: 1. Transvaginal mesh – Also known as vaginal ... Read More

Transvaginal mesh manufacturer should be punished for mishandling documents related to lawsuits

Johnson & Johnson and its subsidiary Ethicon mishandled documents related to its transvaginal mesh devices and should be barred from seeking to throw out lawsuits or using some defense tactics, say attorneys for women who filed lawsuits against the companies. Johnson & Johnson’s unit Ethicon makes the Gynecare Prolift implant, a transvaginal mesh device used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The devices are inserted through the vagina to hold up organs that have dropped for various reasons, usually from childbirth, obesity or age. The devices have been associated with serious complications including ... Read More

PPI treatment Prevpac linked to serious hypersensitivity reactions

A new hypersensitivity reaction warning has been added to the safety label of the prescription proton pump inhibitor (PPI) Prevpac, a package of medications used to treat stomach ulcers, gastroesophageal reflux disease (GERD), damaged esophaguses, and conditions that cause the stomach to produce too much acid. Prevpac consists of a daily administration card containing two PREVACID (lansoprazole) 30 mg capsules, four amoxicillin 500 mg capsules, and two clarithromycin 500 mg tablets. The drugs treat or prevent infections that are proven or strongly suspected to be caused by bacteria. The new warnings inform health care providers to immediately discontinue use and ... Read More

Serious skin reactions linked to anti-seizure drug Onfi (clobazam)

The anti-seizure drug Onfi (clobazam) has been linked to rare but serious skin reactions that have caused permanent injuries and death, the Food and Drug Administration (FDA) warned. New warnings on the drug’s label and patient guide have been updated to describe these serious skin reactions. The skin reactions are Stephens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), and can occur at any time during treatment with Onfi. However, the likelihood of these reactions occurring is greater during the first eight weeks of treatment or when the drug is stopped and then restarted. All cases of SJS and TEN ... Read More

FDA requires new label instructions for OTC topical antiseptic products to reduce risk of infection

New label changes will be made regarding the use of certain over-the-counter topical antiseptic products labeled for preoperative or pre-injection skin preparation in order to cut down on the number of infections associated with the products, the Food and Drug Administration (FDA) announced. “When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections,” the agency said in a safety alert. “However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users.” Outbreaks with the use of contaminated topical antiseptics have ... Read More

Several transvaginal mesh manufacturers involved in lawsuit settlement talks

Settlement talks are currently underway between manufacturers of transvaginal mesh and women who say they suffered serious complications from the defectively designed products. Attorneys for Boston Scientific, Coloplast, Cook Medical, and C.R. Bard entered into discussions to resolve the tens of thousands of lawsuits waged against them. The only manufacturer that did not join the discussion was Ethicon, a subsidiary of Johnson & Johnson. There are more than 30,000 lawsuits against the five companies that are engaged in settlement talks. However, that number is expected to grow to upwards of 50,000 as more plaintiffs join in the settlement proceedings. Transvaginal ... Read More

Transvaginal mesh victim lives in constant and extreme pain

“The pain is so bad that I sometimes go to sleep crying,” Rose Lucero told CBS4 News. “The pain is so bad that I stay up until 5 a.m. trying to let the pain just go away.” In 2008, Rose was implanted with a transvaginal mesh device to treat urinary incontinence. Three years later the pain came. It started in her back and grew progressively worse. Then it spread down her legs and into her feet, making simple chores practically impossible. “I have no life. I can’t do anything without being in pain,” she said. Rose is one of thousands ... Read More

Birmingham, Ala., compounding pharmacy recalls products due to sterility questions

Birmingham, Ala.-based Medaus Pharmacy is recalling certain sterile compounded consumer products because an independent, third-party laboratory’s quality control testing on specific lots could not confirm the sterility of the products. The use of non-sterile injectable products exposes patients to the risk of contracting serious, life-threatening infections. Medaus has not received any reports of adverse effects from products affected by this recall. The recall affects specific lots of testosterone, lipo injection with lidocaine, Taurine, L-Glutathione, Pyridoxine HCL, magnesium CHI, and sodium ascorbate. The products were distributed between March 12 and July 22, 2013 nationwide. Patients and doctors offices that received the ... Read More

Transvaginal mesh manufacturer’s stock drops in light of personal injury lawsuits

Humlebaek, Denmark-based transvaginal mesh manufacturer Coloplast A/S said last week that it didn’t expect lawsuits waged against the company in the United States would have “significant financial impact,” but investors are skeptical. The company’s stock fell as much as 1.8 percent – the lowest since May 2 – making it the worst performing in the benchmark OMX Copenhagen index. The blow comes just a week after a jury in the first federal transvaginal mesh trial – against competitor C.R. Bard Inc. – ordered the manufacturer to pay $2 million in damages to a woman who claimed Bard’s transvaginal mesh device ... Read More