The makers of a popular transvaginal mesh product, Coloplast, have recently settled a large transvaginal mesh lawsuit to the tune of $16 million. The Coloplast Settlement was brought forth against them for creating a defective medical product that caused injury to the female patients who underwent the procedure. Coloplast, which is based in Denmark, had been in settlement talks since January, 2014. They recently agreed to settle a large swath of lawsuits totaling more than 400, resulting in an average disbursement of about $40,000 to each plaintiff.
The transvaginal mesh lawsuits arose from patients who sought treatment for pelvic organ prolapse (POP) – where the muscles that support that organs in the pelvis weaken, causing them to drop down into the vagina. The mesh also was designed to treat another condition called stress urinary incontinence (SUI), a condition that occurs in elderly women where the muscles underneath the bladder become weak, no longer properly supporting it, causing it to drop down.
Transvaginal mesh was designed to be surgically inserted into the vagina or abdomen to provide support to the pelvis and relieve the symptoms. The defective nature of the devices caused the mesh to harden and often break into sharp shards that would penetrate the surrounding organs, resulting in a myriad of health issues and overall discomfort to the patient.
The U.S. Food and Drug Administration (FDA), in the wake of increasing lawsuits against mesh makers, has recently ordered studies regarding these devices and any related damage to the internal organs that they may cause. In 2012, the FDA ordered 30 companies to conduct these studies to determine the efficacy and safety of these products.
According to the civil complaint, Coloplast is involved in civil litigation regarding two transvaginal mesh products they have manufactured: Novasilk-Synthetic Flat Mesh System and the Aris-Transobturator.
In a recent court transcription, a company spokesperson acknowledged that they had been proactively settling a variety of transvaginal mesh lawsuits. They were quoted as saying it was done to: “Buy our peace and move down the road.”
More than 20 manufacturers of these mesh devices are currently facing a transvaginal mesh lawsuit.