Caldera Medical Releases Updated Vaginal Mesh Product

Caldera Medical has released what it’s calling an “improved” version of its Vertessa Lite mesh that is “lightweight, flexible and strong” for sacrocolpopexy procedures. Vertessa Lite is a large-pore, monofilament, polypropylene mesh that blue in color for improved visibility. The new Vertessa Lite is lighter, weighing only 20.9 g/m2. The new Vertessa Lite is also 31 percent stronger compared to “the market-leading mesh,” according to the company, with a suture pull-out strength that is 32 percent greater.

Vertessa Lite also has larger pores of approximately 1,500 microns. Large pore and lightweight mesh is widely recognized to improve host tissue acceptance, while strength and flexibility is important for the durability of the repair. The new Vertessa Lite will be offered in configurations including Y-mesh, flat mesh sheets and mesh strips.

Pelvic organ prolapse is the condition in which one or more pelvic organs bulges or herniates into or out of the vagina. According to several studies, 40 percent of women have some form of prolapse, and it is estimated that up to 250,000 surgical procedures are performed each year to treat pelvic organ prolapse. A sacrocolpopexy procedure restores the vagina to its normal position to correct the prolapse of the vaginal vault in women who have had a prior hysterectomy. Abdominal sacrocolpopexy with mesh placement is considered to be one of the most effective surgical procedures with one of the highest long-term success rates for vaginal vault prolapse.

“As part of our continuous product development efforts we are excited to announce the launch of a new generation of Vertessa Lite,” said Bryon Merade, CEO of Caldera Medical. “Our mission is to improve the quality of life for women and every day we work towards that goal. I am proud to say that we took another step forward with our new Vertessa Lite mesh for sacrocolpopexy, which will improve the quality of life for women suffering from pelvic organ prolapse.”

Caldera Medical develops surgical implants specifically for the treatment of stress urinary incontinence with its Desara Sling System and pelvic organ prolapse with Vertessa Lite across the gynecology, urology and urogynecology specialties.

The company is a privately held company and located in Agoura Hills, Calif.

The vaginal mesh market has been a difficult business in recent years. Thousands of lawsuits against some of the industry’s largest medical device companies have made headlines.

Companies such as Johnson & Johnson (JNJ), Boston Scientific Corp., C.R. Bard Inc., Covidien plc (now Medtronic plc) are fighting vaginal mesh claims in court for years. JNJ’s Ethicon division faces more than 36,000 lawsuits in state and federal courts over related devices. Boston Scientific is dealing with more than 23,000 claims related to vaginal mesh implants. Smaller companies such as Denmark’s Coloplast A/S and the American Medical Systems (AMS) subsidiary of Endo Pharmaceuticals Inc. also have settled many claims. In March last year, Coloplast agreed to pay $16 million to settle lawsuits related to vaginal mesh inserts. In October, AMS officials said the company would add $400 million to its $1.2 billion reserve to resolve “substantially all” claims related to vaginal mesh implants. Caldera Medical has not been immune to litigation, but hasn’t experienced it to the level as some of its larger competitors.

In July 2011, the U.S. Food and Drug Administration reported that it had received nearly 4,000 complaints of injury, death or malfunction associated with transvaginal mesh surgeries performed between 2005 and 2010. As of early 2015, an estimated 70,000 women had filed lawsuits against mesh manufacturers after suffering serious injuries from the products.