Tagged Articles

pelvic organ prolapse 179 articles

Woman says transvaginal mesh impaired her quality of life

Barbara Campbell, 37, was in tears when she met with a new doctor to explain the problems she was experiencing. Severe pelvic pain was keeping her from playing with her kids, doing housework, even being intimate with her husband. The problem started shortly after she had surgery to repair a pelvic floor disorder known as pelvic organ prolapse, or POP, a condition that occurs when the pelvic organs, such as the bladder, rectum or uterus bulge or descend into and sometimes past the opening of the vagina. This common problem is generally caused by childbirth, age or obesity. POP is ... Read More

Safety of medical devices is questioned

What do artificial hips and surgical mesh have in common? They are both considered moderate-risk medical devices and can be approved by the Food and Drug Administration (FDA) without rigorous testing through an expedited approval process known as 510(k). Many of these devices also have allegedly caused patients serious and sometimes permanent disability. This has led critics to question the safety of approving devices for use before they have been fully tested. For example, Johnson & Johnson subsidiary DePuy Orthopaedic received FDA approval through the 510(k) process in 2006 for its ASR metal-on-metal hip replacement system. The device manufacturer was ... Read More

FDA panel supports closer review of vaginal mesh products

A Food and Drug Administration (FDA) advisory panel expressed support for the FDA’s plans to conduct post-marketing studies on risks associated with transvaginal mesh products, but refused to recommend the devices be banned despite pleas from advocacy groups. The FDA’s Obstetrics & Gynecology Devices Advisory Committee met last week to discuss new controversy surrounding surgical mesh used to treat pelvic floor disorders including pelvic organ prolapse (POP) and urinary incontinence. Vaginal mesh for such uses has been associated with problems including organ perforation and bleeding. Long-term risks may include mesh exposure into the vagina, bladder or rectum. Other reported problems ... Read More

Watchdog group urges FDA to ban transvaginal mesh products

The watchdog group Public Citizen is taking aim at a type of surgical mesh used to repair pelvic floor conditions, arguing that the Food and Drug Administration (FDA) should ban the devices because they offer no significant benefits and that they expose patients to serious risks and the potential for permanent life-altering harm. Public Citizen is a national nonprofit consumer advocacy organization that is most recently known for petitioning the FDA to remove the painkillers Darvon and Darvocet based on data that showed the drugs were dangerous to consumers. The drugs were subsequently banned from the U.S. market earlier this ... Read More

Blogger urges others injured by surgical mesh to file report

In December 2010, nine months after surgery where a surgical mesh “bladder sling” was implanted in her body to help with incontinence, Linda started a blog. It was the only way the 63-year-old widow could vent about the complications she experienced after surgery. Since then, she has received more surgeries, is in constant pain, and requires a walker for mobility. “When I started this blog it was out of my own anger and frustration because I researched mesh before I had the surgery,” she writes in an August 17, 2011 entry. “My doctor never once told me about a warning ... Read More

Transvaginal mesh problems lead to questions about device approval

The number of adverse reactions associated with surgical mesh used to repair pelvic floor disorders and other conditions, has skyrocketed in recent years, according to the Food and Drug Administration (FDA). This new data brings into question how the FDA determined the mesh was safe for transvaginal use in the first place. Surgical mesh is used for a variety of procedures, but the device has been shown to cause problems when used trans-vaginally to repair pelvic organ prolapse, a condition in which age, childbirth or obesity cause pelvic muscles and tissues such as the bladder, the top of the vagina, ... Read More

Transvaginal mesh failures become quality of life issues

More tragic stories are surfacing since 2008, when the Food and Drug Administration (FDA) first warned doctors and consumers about serious problems associated with a surgical mesh used to treat common pelvic floor disorders, including pelvic organ prolapse. Since then thousands of women from the United States and the United Kingdom, have filed lawsuits against the manufacturers. The surgical mesh, sometimes called transvaginal mesh, is implanted through the vagina to help support pelvic organs which have dropped due to age, obesity, or childbirth. The condition can cause pain and incontinence. The remedy, however, has put many women in worse shape ... Read More

Women file lawsuits against manufacturers of transvaginal mesh

Lisa Smith of Melbourne, Fla., says the mesh device implanted in her vagina to help with a common condition known as pelvic organ prolapse felt like barbed wire. Even now that it has been removed, the pain lingers. Smith is one of about 300 women in 34 states who have filed a lawsuit against the manufacturers of transvaginal mesh devices. The surgical mesh is designed to repair pelvic floor disorders, conditions that affect an estimated 30 to 50 percent of women older than 50. In pelvic organ prolapse, pelvic muscles and tissues such as the bladder, the top of the ... Read More

Safety of vaginal mesh used to repair pelvic organ prolapse under review

Surgical placement of mesh used to repair pelvic organ prolapse (POP) poses more risks than benefits to women, according to an updated safety communication issued this week by the Food and Drug Administration (FDA). The agency says it will convene an expert panel in the fall to determine whether the vaginal mesh should be banned from the market. Pelvic organ prolapse occurs when the internal structures that support the pelvic organs, such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not ... Read More