Although transvaginal mesh is billed as a minimally invasive procedure for treating pelvic organ prolapse, it has been linked to very serious side effects that have permanently reduced the quality of life for many people. Ethicon’s Gynecare Prosima Pelvic Floor Repair System is one product on a list of transvaginal mesh devices that have been linked with elevated risks by the United States Food and Drug Administration. Between 2008-2010, the FDA received nearly 3000 reports of complications through their adverse event reporting program MedWatch, and they are concerned that this amount of reports is high. Many people who suffer from Gynecare Prosima complications choose to file a lawsuit in order to help them cope with their elevated medical expenses.
Ethicon, a Johnson & Johnson subsidiary, created the Gynecare Prosima Pelvic Floor Repair System as a surgical mesh treatment option for pelvic organ prolapse (POP), a condition that will affect between 30-50% of women in their lifetime. POP occurs when tissues that support the various pelvic organs weaken over time, and the Gynecare Prosima system works as a mesh hammock that provides additional support for any affected pelvic organs, including the bowels, bladder, uterus, vaginal apex, and the rectum. In some cases of pelvic organ prolapse, more than one organ has prolapsed. The FDA has recently informed the public that the serious complications associated with this type of transvaginal mesh are not rare.
Patients treated for POP with Gynecare Prosima and other mesh products are at an increased risk for mesh erosion and other serious complications. Mesh erosion occurs when the sling pushes through the vagina, and is also referred to by the following names:
Mesh erosion is the most common adverse event reported in association with transvaginal mesh slings according to the FDA. In the event of Gynecare Prosima erosion, a patient will likely require a revision surgery in order to remove the mesh device. Unfortunately, sometimes all of the mesh can never be removed from the body, even with multiple surgeries. Other mesh complications include: pain, Dyspareunia, mesh shrinkage, vaginal scarring, emotional problems, organ perforation (bladder/bowels), urinary problems, and infection. Some patients even reported reoccurrence of the initial condition (pelvic organ prolapse).
Many patients who are injured as a result of treatment with Ethicon’s Gynecare Prosima or other transvaginal mesh decide to file a lawsuit against the manufacturer. Filing a lawsuit can help a patient with the medical treatment expenses they encounter while trying to treat their complications. If you were treated with transvaginal mesh and experienced mesh erosion or other complications, call the Willis Law Firm. Our aggressive and talented legal team will provide you with a Gynecare Prosima Lawsuit Evaluation free of charge or further commitment; call us today. We are now accepting vaginal mesh clients nationwide.