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*NEW* Caldera Medical Introduces New Pelvic Mesh

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

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

20 Comments

  1. Janae says:

    Caldera Medical has ruined my life. This is so sad.

    • I also would like to thank you for this recent update, I had the Mesh Sling from AMS implanted in 200, and have since had a Hysterectomy and 3 Revision Surgeries due to complications of the Mesh Sling. I am now about to go under the knife yet again for Urinary Incontinence and Stess Incontinence, and other complications I am still enduring. I am praying that this is successful and I finally get some relief and can go about my everyday activities without any inconveniences, so yes,I would like to thank you again for this update. I hope this new product doesn’t cause as much damage as the older one did.

      • Jane Akre says:

        You should note it is made of polypropylene which itself may be contributing to the problems many women are experiencing. Please do your homework about PP mesh and ask if you are a candidate for abdominal repair using sutures only. The article was not meant to be an advertisement for Calderas new product in that it may not be an improvement over traditional meshes. Thank you.

  2. Teresa R. Jones says:

    Thank you for addressing Caldera Medical, Inc. I am Caldera Medical, Inc. first implant victim of their first product, the Caldera T-Sling. TS005, Lot 0001. I was a Medicaid, uninformed human experiment, approximately 2 years before there was a 510K approval. Implanted in Birmingham, Alabama by the inventor who shared the invention with four others. Dr. Francois Blaudeau, VP of Caldera Sandra Muhlfeld and CEO Bryon Merade are three of the inventors.Nearly 2500 Caldera Medical, Inc. transvaginal mesh research subjects and their families should plan on filling a multi-billion-dollar lawsuit which includes the facilities who assisted in these implants. Victims of Caldera Medical, Inc. surgical vaginal mesh were human experiments both private and government studies were involved and we are left with catrosphic injuries. The victims and their families should determine how to sue Caldera Medical, Inc, its stockholders, Board of Directors, Device Inventors, hospitals and all who were a part of the Medicaid and Medicare fraud., The entire chain of distribution for the devices must be addressed. All American facilities that implanted the device in poor American Medicaid and Medicare victims are subject to future litigation. My implanting surgeon the Inventor, Dr. Francois Blaudeau, Caldera Medical, Inc. and Healthsouth are the individual surgeon inventor, the institution and facility where experiments began in 2004, in Birmingham, Alabama. I have an lawfirm they simply cannot determine how to pursue what is being presented as a company that is having solvency issues. I believe I will have a lawsuit to seek to hold Healthsouth and all other facilities responsible for the experiments because their doctors held key roles on panels that reviewed and approved these dangerous and deadly implants. Caldera victims and their families will seek restitution from insurance companies and brokerage firms for all defendants. Pelvic Implants are a multi billion dollar per year industry, Caldera Medical, Inc. defined the global market annually at 29 Billion dollars. If parties were not insured for the amounts now being claimed, it stemmed from acts of bad faith and fraud based on the underwriters turning a blind eye to the human experiment aspect of these individuals and corporations , therefore victims and their families I am sure will be seeking damages above and beyond insurance policies. I am trying to find how not just to help myself, but all Caldera victims. Caldera has through their attorneys entered tolling agreements that they knew they did not intend to honor and that they never intended on discussing settlements. I am their first victim, I am 11 years implanted, I do not know how nor when this litigation will fully develop or settle, but I am doing my best to speak the truth concerning Caldera Medical, Inc. I do not know how this can happen in America.

    • Jane Akre says:

      Thank you Teresa for your information. Since this is not a publicly held company there is no SEC filing and therefore tough to get answers. I’ll be looking for documents to further explain their involvement and would not at all be surprised to see their name added to the MDL in West Virginia. BTW- they never got back,, I will try again tomorrow. Please keep up updated with whatever you receive and thank you.

    • Janae Johnson says:

      Wow. Same physician I had

  3. anna says:

    OMG there is no way of describing this people. How amazing they haven’t even taking care of the mess they made already. I would say the American Urogynecologic Society are a group of mobsters = monsters who are claiming that they new nothing about the problems that transvaginal meshes would bring to women. Never mine what this pharmaceutical corporate mobster = monsters are thinking of gaining with their new inventions $$$$$$$$$$$$$$$$$$$$$$.. I feel sorry for the women who allow themselves to be talked to by their urogynecologist to place this mesh into them. I hope they explain how many surgeries they would need to remove it. Also, all urogynecologist should not be allowed to implant a mesh, unless they know how to remove it. Every time I decide to see a urologist or urogynecologist they all seem to know who my implanted doctors were. One of the urologist which I saw actually told me that he was glad he wasn’t with the doctor when I had my first mesh placement. He said he had just finished his residency in the hospital where I had the surgery, and knew the implanting doctor very well.

  4. Tammy (KY) says:

    Oh, OK, the new” Golden Standard ” …..wow. Another 510 loophole medical device….. Great.

  5. Sharon says:

    I need this surgery. I am is such dire pain and such a long process. The urogyn is telling me his surgery schedule is booked for the next YEAR, SWEARS I’m only his second patient for this to happen to, and is NOW telling me it’s not crucial I have the mesh taken out even though I’m in horrible pain!! Tells me to take Motrin for the pain and I waited a MONTH for this appointment to be told this. Just made another appt with a different doc from UPENN but have to wait another month to see HER!!

    • Jane Akre says:

      Sharon, where are you located and do you have insurance? Second patient this has happened to sounds unlikely and says he is inexperienced with removals. That is not your ideal choice for a doctor. Please get back or email janeakre@meshnewsdesk.com

    • Teresa Jones says:

      I have the T Sling, another woman you can speak to has the Desera Caldera product, there are 2500 of us suing Caldera Medical. Inc.

      • VICKIE W says:

        Mine was put in 2008..my attorney/case manager claims that caldera medical doesn’t have money to sue for..I find that hard to believe. .anyone know of any settlement with caldera medical?

  6. kitty says:

    It takes 6 months to get in with DRs’ Raz. Or Kim. BOOK IT ASAP

  7. Donna says:

    Looks like, I’m fixing to go down the same road.

    Right now I’m just beside myself…not knowing what to do next. Called the Dr. Secretary, was told mine wasn’t in the recall. But couldn’t get me in to see him for a week. Ouch! Something is poking me, below. Went to the ER, he said yep there it is. Called upstairs, to GYN, was told to give me pain meds and use ky, till my appt. And this is the big central Texas hosp.

    • Jane Akre says:

      Donna- I have no idea what you were told but there is not recall of transvaginal mesh ( with the exception of ProteGen, which wasn’t recalled) A few have been quietly taken off the market. THERE IS NO RECALL!!! What were you told?

  8. VICKIE W says:

    Anyone know of any kind of settlement with caldera medical& our victims?

  9. […] In June 2015, the company launched Vertessa Lite- a polypropylene mesh designed to be lighter, stronger and with larger pores than previous models to treat pelvic organ prolapse.  See the Mesh News Desk story here. […]

  10. tina says:

    I have been told they have no money but if they have funds to create a new and improved product they should have money to settle, feel like I have an infection all the time. Always stabbing pains, no relief much Dr. says to learn to live with it or go under knife again. Nope ain’t happening.

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