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
- 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.
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.