Vaginal Mesh Lawsuits
The Washington Post recently described the plight of a woman who needed surgery for a prolapse of the wall between her rectum and her vagina. During the operation, her surgeon lifted and reinforced her bladder with vaginal mesh.
For two years after the surgery, the patient suffered from constant pain. She had trouble walking and experienced a variety of symptoms, including intermittent fevers, nausea, weight loss, and lethargy.
The patient was one of 3 million women worldwide who have mesh implants to treat prolapse or bladder conditions. She was also one of the 5 percent of patients who experience complications.
Complications from Mesh Implants
A common complication is chronic inflammation caused by mesh that shrinks and becomes covered with scar tissue. The inflammation causes pain and can lead to infection, incontinence, and protrusion through the vaginal wall. Infections can cause sepsis, a life-threatening condition.
A professor of urology at UCLA believes that a significant percentage of women experience “lupus-type” symptoms after a vaginal mesh implant, including runny nose, muscle pain, fogginess and lethargy. He notes that removing the mesh usually causes those symptoms to disappear.
Questionable Reliance on Vaginal Mesh
When muscles and tissues supporting the uterus, bladder, or rectum become weak or loose, those pelvic organs can press into the vagina. That condition is known as a pelvic organ prolapse.
Surgeons sometimes treat pelvic organ prolapse by using vaginal mesh to repair or strengthen weakened pelvic tissues. The mesh is typically placed between the vagina and the bladder or the rectum.
The Food and Drug Administration (FDA), the agency charged with regulating medical devices, issued a safety communication in 2011 warning doctors and the public that serious health complications resulting from the use of surgical mesh to repair pelvic organ prolapse “are not rare.” That is the FDA’s way of saying that vaginal mesh implants pose a serious risk to patients.
The safety communication also expressed the FDA’s finding that no clear evidence proved that treating a pelvic organ prolapse with mesh is any more effective than traditional treatments that do not use a mesh.
The FDA’s Belated Response
The FDA made that announcement after receiving thousands of reports of complications caused by vaginal mesh implants. The agency’s review of medical literature review concluded that erosion of mesh through the vagina is the most common complication.
Nevertheless, for the following five years the FDA took no effective action to improve the safety of vaginal mesh devices. Instead, it continued to approve new devices using a procedure that bypasses safety review protocols if the new devices are “substantially equivalent” to approved devices. As the Washington Post points out, when the approved devices are unsafe, granting near-automatic approval of similar devices merely causes more unsafe devices to reach the market.
Five years after issuing its safety communication, the FDA reclassified surgical mesh used for pelvic organ prolapse repairs from “moderate-risk devices” to “high-risk devices.” That action requires vaginal mesh manufacturers to provide convincing evidence that its devices are safe, rather than relying on their similarity to other products that have already been approved. While that regulatory action is welcome, it does little to help the women who are experiencing complications from vaginal mesh that, once implanted, is very difficult to remove.
Vaginal Mesh Lawsuits
Four states have sued Johnson & Johnson and its mesh manufacturing subsidiary, Ethicon, alleging that the companies deceived physicians and the public by failing to disclose the risks associated with vaginal mesh. The states intervened because federal laws shelter device manufacturers that receive FDA approval to market specific medical devices.
Those barriers, however, are not insurmountable. More than 100,000 women have filed lawsuits against Ethicon, C. R. Bard, Boston Scientific, and other mesh manufacturers for complications arising from vaginal mesh implants.
In 2016, a jury awarded three women a combined verdict of more than $14 million for injuries caused by a Boston Scientific mesh device. Boston Scientific also announced a settlement of more than 6,000 mesh lawsuits for $457 million.
In 2017, Endo International paid $775 million to settle 22,000 mesh lawsuits. In April 2018, a New Jersey jury awarded $68 million to a woman in the first of several scheduled lawsuits against C.R. Bard alleging injuries caused by its vaginal mesh devices.
Lawsuits are allowed to proceed, despite FDA approval of mesh devices, for several reasons, including evidence that the manufacturers withheld unfavorable information or actively deceived the FDA when they sought regulatory approval. For example, an investigation published in the British Medical Journal concluded that Johnson & Johnson paid a Swedish obstetrician one million dollars to make clinical trials seem successful.
As more vaginal mesh devices deteriorate and begin to cause complications in patients, the number of lawsuits will only rise. An attorney in your state who handles medical device lawsuits can advise you about your right to seek compensation if you are experiencing pain or other problems resulting from a vaginal mesh implant.