Women who have surgical mesh implanted to repair their pelvic organ prolapse (POP) should pay close attention to the U.S. Food and Drug Administration’s (FDA) latest alert. Since 2008, they have warned that the mesh could cause serious complications after surgery. But with the latest safety communication in July, the FDA says that “…serious complications associated with surgical mesh for transvaginal repair of POP are not rare. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Surgical mesh is made by many different manufacturers and in 2010, these implant procedures were done on 100,000 women for POP, with 75,000 of them via transvaginal methods. The mesh helps to repair weakened or damaged tissues that help keep the pelvic organs in place for patients with POP and stress urinary incontinence (SUI). The FDA estimates that 30 to 50 percent of women can develop POP during their lifetime.
The most frequent complication of the surgical mesh is erosion of the mesh through the vagina. FDA’s review found that this problem can trigger the need for numerous surgeries and can cause pain, bleeding, infection, organ perforation, and urinary issues. Additionally, some patients have reported neuro-muscular issues, vaginal scarring and shrinkage, recurrent prolapse, and emotional distress.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said FDA’s Center for Devices and Radiological Health deputy director Dr. William Maisel. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”
In early August, The American Journal of Obstetrics & Gynecology published a study involving more than 500 patients who underwent Prolift mesh repair between 2005 and 2009. Globally, more than 11 percent of the patients had to get surgeries after the initial implant of the mesh. Consequent surgeries were needed to correct urinary incontinence, mesh complications, and the recurrence of prolapse.
The FDA says that all manufacturers must review the safety and effectiveness of their mesh products. In early September, the FDA will review mesh and other OB/GYN devices during their Medical Device Advisory Committee meeting.
Women who were not given proper warnings by their doctor or have suffered injuries due to a manufacturer’s surgical mesh should seek legal action for their pain and suffering, lost wages, and medical bills. Patients can utilize other surgical procedures to remedy POP and SUI that do not involve mesh.
The Connecticut personal injury attorneys at Stratton Faxon are one of the top three plaintiff law firms in the state. They have helped many individuals recover millions of dollars for their losses, including medical bills, loss of income, and pain and suffering. They are revered for tenaciously working to prove that the guilty party has a legal responsibility for your injury and that the damages claimed reflect the total extent of your injury or loss.
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Alexandra Reed writes for Connecticut personal injury law firm, Stratton Faxon. Contact Stratton Faxon to speak with a Connecticut accident lawyer about your personal injury, wrongful death, or Connecticut malpractice case. To learn more, visit Strattonfaxon.com.
