caldera vertessaDespite 100,000 defective product lawsuits facing makers of  polypropylene pelvic mesh, device maker Caldera Medical has plans to launch a new version of pelvic mesh to be used to treat pelvic organ prolapse.

The Vertessa Lite has been cleared by the U.S. Food and Drug Administration through its 510(k) approval process. Light blue in color, Caldera says this mesh is lighter, stronger and has larger pores than previous models so the woman’s own tissue accepts the product with fewer side effects.

It continues to be made of monofilament polypropylene and comes in sheets, a Y-shape or a strip.  The pores are measured at 1400 microns, which the company says is nineteen times greater than other meshes and allows for “macrophage movement” and “fibroblast ingrowth.”caldera vertessa loop size

Vertessa is to be used for sacrocolpopexy placement, that is an open abdominal surgical technique rather than through the vagina (transvaginally). Most of the existing lawsuits named in product liability lawsuits involve mesh implanted through the vagina.

Experts at trial have called a transvaginal placement passing mesh through a clean-contaminated field that sets the stage for chronic infection. Experts believe polypropylene mesh (PP) incites a foreign body response as the mesh encapsulates the petroleum product and tries to rid the body of it.

Caldera’s representative did not respond to a call by the time of publishing. Any additional comments will be added

as they come in.

Caldera Medical, of Aurora Hills, California,  is among mesh manufacturers facing litigation from women who claim the polypropylene mesh products cause chronic infections, pain, nerve entrapment, reoccurrent urinary problem, reoccurrence of the bladder and bowel prolapse and mesh erosion, among other ailments.

Mesh makers have been quietly removing their products from the market. This is the first new mesh introduced in two years.

 

Abdominal Placement

**Late Add  – A reader points out that Ethicon recently released its Artisyn mesh used to treat vaginal vault prolapse and it too is abdominally placed, avoiding the transvaginal clean-contaminated route. Ethicon (J&J) removed its Prolift mesh, one of the largest and most problematic, from the market in 2012.

An estimated 225,000 women receive treatment surgically to treat pelvic organ prolapse. Abdominal sacrocolpopexy was assumed to provide longer lasting effectiveness. An article in the Journal of the American Medical Association (JAMA) in 2013 determined failure rates for an abdominal sacrocolpopexy increased over a seven-year period.

The FDA said in 2011 that complications from transvaginal mesh are “not rare” and it’s not clear whether mesh is more effective than a traditional surgical repair using suture alone. Meanwhile the agency has been stuck on a proposal to reclassify pelvic organ prolapse mesh to Class III, meaning it could not be approved only through the 510(k) clearance but would have to undergo rigorous testing before being marketed.

Caldera Medical is one of 33 mesh manufacturers who received letters from the FDA in January 2012 to follow complications among women implanted with its mesh products. To date, those studies have not been completed.  See story here.

caldera logoCaldera Medical 

Caldera is a manufacturer often linked as a co-defendant with American Medical Systems litigation over pelvic mesh. See case here.

Caldera Medical says it is dedicated to “improving the quality of life for women.” It develops and markets surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).  Products on the market include the Desara Sling System (for SUI) and the Vertessa Light (for POP). The Desara products can be placed with multiple approaches including transvaginally, suprapubic and transobturator.

Caldera Medical launched the Desara SL, Mini and Blue at the American Urogynecologic Society meeting in October 2013. See press release here.

Acosta v. Caldera was filed in the Superior Court of the state of California, Los Angeles on June 11, 2014. It was transferred April 2014 to So District of WV.

LEARN MORE: 

Calderas Medical Press Release 

http://www.fiercemedicaldevices.com/press-releases/caldera-medical-announces-fda-clearance-new-generation-vertessa-lite-polypr

Here is the brochure

https://www.calderamedical.com/VL_Brochure_RevC_041014.pdf

JAMA, May 15, 2013,  Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

http://jama.jamanetwork.com/article.aspx?articleid=1687577

Caldera – Launch of the Desara, August 2013

http://www.businesswire.com/news/home/20131015006880/en/Caldera-Medical-Introduce-Products-American-Urogynecologic-Society#.VZGZ8flVhBc

Mesh News Desk, Caldera Medical among 33 mesh manufacturers to follow-up on complications.

See story here

https://www.meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests