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high risk 22 articles

Female incontinence treatment linked to serious complications

More than 20 million women in the United States suffer from urinary incontinence, but devices intended to remedy the problem are at the center of thousands of lawsuits by women who claim the treatments ruined their lives. Jennifer Ramirez says her incontinence wasn’t a serious problem for her. She opted to have transvaginal mesh implanted to keep the problem from getting worse following a hysterectomy. Now, she lives in constant pain. Just talking about it brings her to tears. “Now my life has to revolve around having a restroom right there because when you have to go, you have to ... Read More

FDA wants to reclassify transvaginal mesh as high-risk medical device

The Food and Drug Administration (FDA) proposed reclassifying transvaginal mesh devices from moderate-risk to high-risk, requiring manufacturers to submit a premarket approval application for the agency to evaluate a device’s safety and efficacy before the device can be approved for marketing. Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat common pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh holds up organs that have dropped due to the stress of childbirth, obesity or age, causing symptoms such as incontinence, pain during sexual intercourse, and general discomfort. ... Read More

FDA calls for stricter safety guidelines, pre-market approval for transvaginal mesh for incontinence

Stricter safety requirements may be required for the manufacturing of transvaginal mesh under a Food and Drug Administration (FDA) proposal. The surgical mesh used to treat common pelvic floor disorders in women should be reclassified as “high risk,” the agency said in response to mounting reports of complications from the device. Transvaginal mesh, also known as vaginal mesh or a bladder sling, is used to treat pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have dropped causing symptoms such as discomfort and incontinence. The mesh was widely used in women ... Read More

Gene scanning gives more accurate, detailed results than conventional prenatal testing

Prenatal testing can give expectant parents insight into the health of their unborn child, but the tests are not foolproof. A new wider use of gene testing in early pregnancy that involves scanning the genes of a fetus can give more accurate results about potential health risks than current prenatal testing. A study published this week in the New England Journal of Medicine compared current prenatal testing to gene scanning and found that a surprisingly high number – 6 percent – of fetuses that were found to be normal by conventional testing were found through gene scans to have genetic ... Read More

Pelvic Floor Disorder Alliance aims to educate, empower women

One in three women have a pelvic floor disorder, yet many women refuse to seek treatment, leaving them to suffer in silence, according to new research issued by the Pelvic Floor Disorder (PFD) Alliance. The lack of awareness and stigma around these issues prompted the PFD Alliance to launch a public awareness campaign to help women impacted by pelvic floor disorders and minimize any discomfort around seeking education and treatment for the condition. The campaign, “Break Free from PFDs,” aims to help women understand the facts about PFDs and empower them with information on how to pursue individualized solutions for ... Read More

J&J sold transvaginal mesh product against FDA’s orders

Johnson & Johnson continued to sell its transvaginal mesh product for nine months after the Food and Drug Administration (FDA) told the company to stop marketing the controversial device, court records show. This discovery could lead to higher awards in the more than 1,400 lawsuits filed against Johnson & Johnson’s Ethicon unit by women who say the mesh caused organ perforation, pain, scarring and nerve damage. In a letter dated August 24, 2007, the FDA told Johnson & Johnson to stop sales of Gynecare Prolift until the agency could determine whether the device was “substantially equivalent” to other transvaginal mesh ... Read More

Study shows daily insulin injections do not raise risk for heart attack, stroke, cancer

The safety of diabetes medications has been a concern since the Food and Drug Administration (FDA) issued warnings about cancer and heart attacks associated with the type 2 diabetes drugs Actos and Avandia. For decades, people have wondered if the use of another diabetes medication – insulin – made diabetics more susceptible to cardiovascular disease and cancer. But, a new study offers some peace of mind, indicating long-term, daily injections of insulin do not appear to increase the risk for heart attacks, strokes, or cancer in people with type 2 diabetes or pre-diabetes. The new international study, led by Canadian researchers, ... Read More

Drug overdose antidote may become available over the counter

For the first time, the Food and Drug Administration (FDA) says it will consider allowing the over-the-counter sale of an overdose antidote as a way of curbing the rising death toll from drug overdoses each year. The FDA along with the Centers of Disease Control and Prevention (CDC) and the Drug Enforcement Agency (DEA) gathered last month to discuss strategies to fight prescription drug abuse and misuse. A key topic was widening the availability of naloxone (Narcan), a nontoxic, non-addictive drug that can reverse the potentially fatal opioid overdose. Some of the most misused prescription opioid painkillers include Oxycontin and Vicodin. ... Read More

Transvaginal mesh maker profiting despite mounting lawsuits

C.R. Bard Inc. is rolling in higher profits after postings its third quarter results, but the celebration may be short lived. The medical device company is facing dozens of lawsuits from patients who have asked to join a multi-district federal case against the company for allegedly selling defective and dangerous products, namely its Avaulta transvaginal mesh. The multi-district litigation, consolidated from 21 individual lawsuits earlier this fall, includes complaints from women who received three different types of Avaulta mesh – Avaulta Biosynthetic, Avaulta Plus, and Avaulta Solo mesh. Earlier this year, 29 other women who had previously filed lawsuits against ... Read More

FDA reviews safety of transvaginal mesh

The Food and Drug Administration (FDA) this week is reviewing the safety of surgical mesh used to repair pelvic floor disorders based on a recent report that found transvaginally implanted mesh fail to lead to better outcomes than non-mesh repairs and should be reclassified as posing a high risk to patients. Patient groups are also demanding a recall of the so-called moderate risk devices, saying they were permanently injured by the products. Surgical mesh products are made of non-absorbable synthetic material and are used during transvaginal surgery to repair pelvic organ prolapse (POP), a common condition in women caused by ... Read More