Johnson & Johnson and Coloplast Corporation are facing a new Restorelle mesh lawsuit, alleging that the transvaginal mesh caused complications that compounded the claimant’s medical condition.

The Restorelle mesh lawsuit was filed by a couple from California, alleging the companies failed to warn them against the potential device complications of their transvaginal mesh product.

Plaintiff couple Julie C. and Ray C. filed this Restorelle mesh lawsuit soon after discovering other women reported similar complications that they allegedly were not warned about in advance.

According to the couple, Julie had the Restorelle mesh product implanted to treat her stress urinary incontinence (SUI), and had no reason to believe she was at risk for serious device complications that could compound her health.

The Restorelle mesh system and other transvaginal mesh products are prescribed to women suffering from pelvic organ prolapse (POP) or stress urinary incontinence, which develops due to physical trauma in the pelvic region. These physically traumatic events can be caused by childbirth or other events that can induce similar damages, which ultimately causes the woman to lose control of her lower pelvic muscles.

Transvaginal mesh products are supposed to provide women with a discrete way of treating these highly personal health problems.

Overview of Restorelle Mesh Lawsuit

With these benefits in mind, Julie says she agreed to have the Restorelle mesh implanted and underwent the procedure on Feb. 17, 2014. The Restorelle mesh lawsuit states that not long after the device was implanted, Julie says she began experiencing serious device complications that required prompt treatment action.

Julie reportedly suffered serious bodily harm requiring surgical explantation of the defective hernia mesh product. This procedure was performed on Aug. 29, 2016 in which a portion of the mesh was excised. Julie says she is contending with the chronic complications caused by the hernia mesh, and will most likely need treatment for these injuries for a long time to come.

Julie and Ray opted to file this Restorelle mesh lawsuit arguing that the product posed significant risk to women, and that the FDA had warned that transvaginal mesh complications were “not rare” events. In 2016, the FDA reclassified transvaginal mesh devices as Class III devices, which is a designation for high risk products approved by the agency.

Even though surgical mesh has been used to treat POP since the 1990s, the FDA did not officially approve this use until 2002. By 2011, the FDA had reportedly received 4,000 transvaginal mesh injury reports indicating serious injuries and even death between 2005 and 2010.

The FDA has further stated that transvaginal mesh products are no more effective than other surgeries, and can even expose patients to greater risks. The complications patients can suffer from transvaginal mesh products include, but are not limited to:

• Painful sexual intercourse
• Urination problems
• Pelvic organ prolapse
• Vaginal scarring
• Perforated bladder, bowel, or blood vessels
• Mesh erosion into the vagina
• Infection
• Internal organ injuries

Even though these transvaginal mesh complications can be devastating to patients’ health, Johnson & Johnson and Coloplast allegedly failed to warn consumers, plaintiffs claim.

Julie states she would not have agreed to have the Restorelle mesh product implanted if she had known the severity of the potential device complications. Julie and Ray’s Restorelle mesh lawsuit is seeking damages for medical expenses, along with negligence and loss of consortium.

This Restorelle Mesh Lawsuit is Case No. 8:18-cv-01539, in the United States District Court of the Central District of California.