Millions of women have been implanted with transvaginal surgical mesh implants or slings, in surgical procedures to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is a form of plastic that has been linked to a high rate of serious complications.
We believe this is a serious women’s health issue. Women throughout the country have filed transvaginal or pelvic mesh lawsuits seeking compensation for serious injuries, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection, continued and worsening incontinence, pain and emotional distress.
The lawsuits have been filed in New Jersey state court, as well as in federal courts throughout the United States.
In the video below, I summarize the risks and injuries women have suffered from transvaginal and pelvic mesh.
2014: FDA Proposes Stricter Guidelines for Surgical Mesh
In April 2014, the FDA proposed stricter safety requirements for plastic mesh used to repair pelvic collapse. The new rule reclassifies surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. The FDA has also proposed to reclassify urogynecologic surgical mesh instrumentation from class I to class II. If the proposal were to successfully pass, both POP and urogynecologic surgical mesh instrumentation would be regulated under a stricter guideline under their new designation and class.
The FDA has tentatively concluded that current controls and regulations are not enough to provide safety and effectiveness using this device, especially in comparison to traditional surgery with stitches that have fewer complications.
Complications from surgical mesh were first brought to the FDA’s attention nearly three years ago. Since then, the agency has received over 1,500 reports of complications, and over 650 patients have filed lawsuits as a result of their injuries. There have been approximately seven reported deaths associated with POP repairs, three of which were related to the mesh placement procedure.
Contact Lieff Cabraser
If you or a family member have suffered an injury as a result of the operating room use of surgical mesh, please feel free to contact one of the female injury attorneys at Lieff Cabraser for a free, no-obligation review of your case. Or, if you prefer, you can telephone us toll-free at 1 800-541-7358.
By Wendy Fleishman.