An Indiana couple has filed a product liability lawsuit over problems with a Caldera Medical Desara vaginal sling , which caused the wife to experience severe complications similar to those that have been linked to several transvaginal mesh products. Durham indicates that she received a Caldera Desara sling on October 15, , and alleges that the she suffered serious bodily injuries, mental and physical pain and suffering, including vaginal pain and painful sexual intercourse, as a result of complications with the sling. According to the lawsuit, the Caldera Medical Desera vaginal sling was defectively designed and the manufacturer failed to adequately warn about the risk of problems following use of the sling during transvaginal surgery. The Desara sling contains material that is not inert, reacting to human tissues and bodily functions in ways that adversely affect a patients health, according to allegations raised in the complaint. Durham also alleges that the mesh harbors infections and can migrate from its original location, becoming embedded in human tissue. Durham is suing the manufacturers for negligence, breach of warranty, manufacturing and design defects, as well as failure to warn. Her husband has brought a claim for loss of consortium, and the couple seeks compensatory damages, as well as punitive damages in the lawsuit. The case joins a growing number of vaginal sling lawsuits that have been filed throughout the United States over problems with similar products made by a number of different companies, including American Medical Systems AMS , C. Bard , Boston Scientific and Ethicon.
Caldera Medical, Inc.
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Search FDA. The Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed postmarket surveillance PS studies are conducted effectively and efficiently and in the least burdensome manner. CDRH efficiently identifies the reporting status of active PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PS study.
Pelvic Mesh 101: Mesh Basics – Still on the Market
In June, , C. See Mesh News Desk story here. AMS sold its gynecological device division to Endo and it was closed. Pelvic mesh, sling, transvaginal mesh, TVT, hammock- some of the names for transvaginal mesh. This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today! Transvaginal mesh means it is placed through the vagina. Enterocele — upper posterior vaginal wall and small bowel. POP is measured in four stages from zero to 4. Page four and five of this FDA page shows the female anatomy and what can go wrong.
The man I started dating 8 years ago, long before med school was in the picture, is disappearing before my very eyes. There may be underlying personality similarities, but if the answer to "what shall I do next" is always trumped by a Morman frame of reference for one partner, but not the other, conflict is inevitable. This blog accommodates some frank admissions about that which is less than wonderful about LDS. I will have time to build a life with friends and activities and travel of which he will be a minor part. I would show her this recent post for example: Her family will also be thinking about this and will talk to you about it when you spend time with them. I have believed in for better for worse but I cant do it any longer.