Transvaginal Mesh Lawsuits: History and Current Status
Legally Reviewed and Edited by: Terry Cochran
Many women have filed transvaginal mesh lawsuits in recent years due to significant health complications directly related to manufacturer or surgical deficiencies.
What is Transvaginal Mesh?
Doctors use transvaginal mesh to treat women with pelvic floor problems. The mesh, comprised of synthetic materials, supports weakened or damaged tissues after surgical repair.
Up to half of all females eventually develop weakness in the muscles or tissues that hold the uterus, bladder, or rectum in place. The weak muscles cause these organs to droop and press on the vagina.
Doctors treat this condition, called pelvic organ prolapse (POP), by performing surgery and implanting transvaginal mesh. Once mesh has been implanted, it is usually impossible, to remove.
Surgical mesh has been used for over 50 years. Initially used by surgeons to support the abdominal wall after a hernia operation, since the late 1990s many surgeons began using it in women to repair pelvic organ prolapse and urinary incontinence.
The Food and Drug Administration (FDA) did not formally approve the use of transvaginal mesh until 2002.
Within a few years, the FDA began receiving numerous complaints about complications as a result of transvaginal mesh procedures. Complications reported include pain during sexual intercourse, hemorrhaging, infections, reoccurrence of POP, and urinary incontinence. Some reports also indicated that the mesh had eroded some of the inner linings of the vaginal wall.
Although until recently three-quarters of all women who suffered from pelvic organ prolapse had a surgical mesh procedure, the remaining women underwent a colporrhaphy operation.
A colporrhaphy is a minimally invasive surgical reconstruction of the walls of the vagina that have been injured by POP.
FDA investigators issued a statement recently noting that there was no evidence that vaginal mesh was more effective than a colporrhaphy.
FDA Shut Down
The FDA first issued an FDA Safety Communication regarding surgical mesh in 2011. Later that same year, the FDA issued 522 orders to 34 manufacturers. A 522 order requires the manufacturers to conduct a post-market surveillance study on the use of the product. Most manufacturers stopped marketing mesh after the 522 order.
In January 2106, based on further FDA investigation, the FDA reclassified transvaginal mesh as Class III, the highest risk classification. Any Class III product brought to market must pass exceptionally stringent FDA reviews before approval.
In April 2019, after many years of complaints, the FDA ordered a halt to the use of transvaginal mesh.
From about 2009 until the FDA shutdown, pelvic mesh tort claims had already ranked among the most lawsuits ever filed in the United States for any product or procedure.
Up until the beginning of 2019, over 100,000 claims due to transvaginal mesh problems have been filed.
Makers of Transvaginal Mesh
Five companies in the United States manufactured transvaginal mesh: C.R. Bard, Ethicon, American Medical Systems, Boston Scientific, and Proxy Biomedical.
These companies have agreed to set aside hundreds of millions of dollars to settle outstanding lawsuits.
Johnson & Johnson
Johnson & Johnson own Ethicon, which produced one of the most popular types of vaginal mesh for over a decade. Plaintiffs have targeted Johnson & Johnson more than any other manufacturer.
Jurors have awarded multi-millions of dollars to women injured permanently by the mesh. In 2016, Johnson & Johnson set aside $120 million to settle the then 4,000 lawsuits filed against the company regarding vaginal mesh.
Since then, more vaginal mesh lawsuits against the company have resulted in more significant monetary settlements.
For example, in 2018, two women received jury verdicts of $35 million: $10 million in damages and $25 million in punitive damages.
Eileen Kroll, a registered nurse and trial attorney at Cochran, Kroll & Associates, P.C. has a great deal of knowledge and experience working with patients who have had complications with mesh, and she is available to answer your questions. Contact her, or any other member of our law firm at 866-MICH-LAW for a free consultation. Our law firm never charges a fee unless we win your case.
Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.