Transvaginal Mesh Death
If someone you love died after receiving transvaginal mesh, you might be eligible to file a wrongful death claim. To find out more information contact our transvaginal mesh lawyers to schedule a free review of your case.
Fatal Surgical Mesh Complications
Fatalities may occur during placement of transvaginal surgical mesh, if for example, the surgeon nicks adjacent organs causing perforation. Hemorrhage is also a potential fatality. The mesh itself can erode into vaginal or other tissue.
Fatalities also can occur when attempting to remove the mesh after complications become evident. Removal of the mesh can be very difficult. At times, the patient's tissue can grow into the mesh, making it almost impossible to remove it all. In addition, the mesh can contract, causing complications with the woman's tissue.
In just two years, between 2008 and 2010, seven deaths were reported to be associated with transvaginal pelvic organ prolapse (POP). Three of the deaths, the U.S. Food and Drug Administration (FDA) said, were due to placement of the mesh during surgery. These surgical complications were two perforations of the bowel and one instance of hemorrhage. Four of the deaths were due to post-operative medical complications.
Use of transvaginal surgical mesh to treat POP is becoming increasingly controversial. The FDA has been investigating complications of using transvaginal surgical mesh and has released two reports, one issued in October 2008 and an update published in July 2011. In September 2011, the agency will convene an advisory panel of outside experts to consider conducting clinical studies to "improve our understanding of the safety and effectiveness of urogynecologic mesh."
FDA Might Tighten Restrictions
The FDA is considering changing some of the regulations regarding transvaginal POP mesh repair. The FDA states that serious complications associated with this procedure and use of mesh are not rare. This is contrary to the agency's opinion stated previously in its 2008 report.
In the July 2011 update, the agency identifies a newly recognized complication of transvaginal mesh POP surgical repair. Mesh contraction can result in vaginal shortening, tightening and pain.
Other complications include mesh erosion through the vaginal wall, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems.
Among the regulatory changes the FDA is considering are:
- Changing the risk classification of using mesh for transvaginal POP from Class II to Class III. This would require manufacturers to submit applications for premarket approval.
- Requiring manufacturers to submit data regarding use of the mesh in human subjects; that is, they would have to do clinical studies.
- Expanding the monitoring of how well the devices perform once they are on the market
Do You Qualify for a Transvaginal Mesh Lawsuit?
If someone you love died as a result of a complication of vaginal mesh, you might qualify for compensation. To learn more, please contact us today. Our transvaginal mesh death lawyers will review your case during a free initial consultation and will let you know if you qualify to file a legal claim.