Caldera Medical manufactures and designs surgical mesh used in a variety of different functions, one of which includes a transvaginal mesh implant designed to treat pelvic organ prolapse or stress urinary incontinence. Desara is one of the mesh implants produced by Caldera, used for stress urinary incontinence. According to Caldera, the polypropylene mesh can withstand 5lbs. of force, and the large porous mesh promotes tissue ingrowth resulting in increased stabilization. Unfortunately, the vaginal sling is very similar to other products on the market, and like its competitors, many patients with Caldera’s Desara implants have suffered serious complications such as:

  • Urinary tract infection
  • Urge symptoms
  • Infection
  • Difficulty with urination
  • Mesh erosion
  • Vessel/urethra perforation

What is Stress Urinary Incontinence?

Stress urinary incontinence (SUI) occurs due to weak muscles in the lower urinary tract. When the pelvic floor muscles are stretched from weight gain, pregnancy, or other conditions, the weakened muscles are unable to support the bladder properly and tighten the muscles that close off the urethra. Urine may leak from even minor pressure from laughing, exercising, coughing, or sneezing. In the case of severe SUI, surgical intervention is necessary to reinforce the weakened pelvic floor muscles.

Transvaginal Slings

Vaginal slings such as the Caldera Desara were manufactured and marketed as solutions to SUI. Because many patients experience recurrent SUI after traditional surgery, patients and doctors believed transvaginal mesh implants offered a more permanent and effective solution. Despite the lack of any scientific evidence supporting such claims, thousands of women received vaginal sling implants believing it to be a better solution to their condition, only to find themselves facing severe complications from the mesh.

FDA’s Request for Clinical Testing

Any implant can potentially become harmful, extrusion is a common problem for implants in any part of the body bearing weight or pressure against soft tissue. Due to the evidence gathered by the FDA adverse event reporting system, suggesting the increased risk of transvaginal implants, the FDA has asked all transvaginal manufacturers to conduct clinical trials testing the safety and efficacy of these devices. Although many manufacturers have decided to withdraw their transvaginal mesh slings from the market, Caldera has yet to do so and continues to reap profits from a product that has yet to be proven safe.

Lawsuits Against Caldera

Like many of its competitors, Caldera is currently facing lawsuits filed by women who have suffered serious complications related to their Caldera mesh implants. The lawsuits allege that the severe complications experienced by the plaintiffs are due to the defectively designed implant. Already, one California couple has been awarded $5.5 million after the woman had to undergo eight revision surgeries to remove the harmful device.

Seek Legal Representation

If you are one of the thousands of women who have suffered serious injuries related to the Caldera Desara implant or another Caldera transvaginal device, be sure to protect your rights to compensation by seeking professional legal representation. For a free consultation with a qualified attorney, please contact our transvaginal mesh injury lawyers to schedule an appointment.


5 Comments

  1. Mary Miller
    Jul 22, 2013 @ 03:34:13

    I have a very long story. Would like to talk to someone about it. The Caldera T-Sling TS10 was placed in 2005. It eroded at the time it was placed but I was unaware of that until 2006. The sling eroded through the urethra and into the bladder. When trying to remove it, a small piece was adhered to the bladder wall and unreachable since the physician was trying to remove it all vaginally. I suffered constant bladder infections and spasms and had taken nitrofurantoin from 2005-2009, when the last piece was finally lasered after a bladder stone formed over it. I had a total of 10 procedures which included two for a recent discovery in 2013 that revelaed more of the mesh had migrated into the vaginal wall. I also developed a lung condition called eosinophilic pneumonia due to the nitrofurantoin. Please let me know if any action can still be taken against Caldera.
    Thank you,
    Mary Miller

    Reply

    • Christine
      Aug 06, 2013 @ 02:21:34

      I too had a Caldera T sling placed in 2006 and I just had surgery to remove the sling. You need to contact a Vaginal Mesh lawyer, I think mine is a TS10 . It is almost near impossible to have the total sling removed. Unless your doctor made an incision in your groin to remove the arms of the sling they are still there! Start by talking to a Urogynecologist, mine was in Georgia. Most physicians are not experienced in the mesh removal or they only remove small pieces of it. email me for more info

      Reply

      • Darlene staats
        Apr 13, 2014 @ 23:14:36

        I am in Georgia have had 3 surgeries so far who is your dr? I know they didn’t get it all last surgery in 2006 I’m still in pain

        Reply

      • Jan
        Aug 01, 2014 @ 15:41:26

        Please if you can tell me a doctor in the East that can see the mesh as The arms were not removed ! I am not surprised I am still having trouble and I wondered if the arms go around your spine ? My lower back pain is intolerable and standing up is very much limited … Please email me any information you have on this and thank you !

        Reply

  2. Gretchen
    Feb 16, 2014 @ 04:32:09

    I found my op report and it says a Desara sling was used even though my doc said they don’t use mesh so I assumed I had a traditional surgery done until I developed temporary crippling pelvic pain for two months with no known reason. Surgeon said no use in doing any imaging and said to do physical therapy instead. PCP said not to ask it could make it worse. Glad the pain went away and hope it doesn’t come back since the doctor who did the surgery wanted nothing to do with me when I developed pain about a year after the pain started. It felt like something was stuck and
    couldn’t stand up straight for months. Really really hope the mesh hasn’t eroded since no doctor has attempted to see if it has. I also have Incontience symptoms again but much more mild. I wish I hadn’t had this surgery.

    Reply

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