Caldera Medical Acquires Gynecare TVT™ Product Line from Johnson & Johnson’s Ethicon

Mar 22, 2025 17:43 CST Updated 17:43

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March 20, 2025Caldera Medical Announces Acquisition of Ethicon’s (Johnson & Johnson) Gynecare TVT™ Product Line, Driving Global Transformation and Expansion for Women's Health CompanyThis acquisition marks an important strategic layout for Caldera Medical in the field of women's health, further solidifying its leading position in minimally invasive treatments for stress urinary incontinence.

EstablishLeadership in Stress Urinary Incontinence

Caldera Medical is a medical device company focused on women's health, established in 2002, with its headquarters located in California, USA.The company is dedicated to the development, manufacturing, and sales of top-tier minimally invasive surgical products for the treatment of gynecological conditions such as stress urinary incontinence, pelvic organ prolapse, polyps, and uterine fibroids. Caldera Medical's mission is to "improve the quality of life for women" and, through close collaboration with surgeons, provide high-quality medical services to women worldwide.

Caldera Medical Announces,Caldera Medical officially acquired the Gynecare TVT™ series products from Ethicon on March 20, 2025, and will complete the product handover in the coming months.

The TVT™ product line includes TVT, TVT Exact, TVT-O, and TVT Abbrevo, offering minimally invasive treatment options for women suffering from stress urinary incontinence (SUI). As part of this acquisition, Caldera Medical will retain the original manufacturing facilities, materials, and specialized production team for the TVT products. This ensures a seamless transition for surgeons, patients, and partners, as the same manufacturing processes, materials, and expert team that have been changing lives remain in place. With over two decades of clinical data, including patient follow-ups lasting up to 20 years, the proven performance and efficacy of TVT have remained consistently reliable.

Caldera Medical CEO Bryon Merade said: "This acquisition marks an important step forward in our mission to transform women's health. The inclusion of the TVT product line into our portfolio reinforces our steadfast commitment to providing safe and effective solutions for surgeons and their patients."We are honored to continue the success of this product line and expand its influence, providing proven treatment options for more women worldwide."

In the coming months, Caldera Medical will expand global customer support for TVT products and increase investment to provide advanced medical services to more women. The combination of Caldera Medical's established expertise in pelvic health and TVT’s proven success further solidifies its position as a leading provider of advanced solutions for women.

Before this acquisition,Caldera Medical Acquires Atlantic Therapeutics and Its Innovo Non-Invasive Solution for Treating Bladder Leakage in September 2023, and Acquires UVision360 and Its Luminelle Product Line for Hysteroscopy and Cystoscopy in October 2024.These acquisitions not only accelerated the growth of Caldera Medical but also demonstrated its commitment to expanding access to life-changing treatment options, backed by a legacy of clinical success and a focus on improving patient outcomes.

Treatment of Female Stress Urinary Incontinence“Gold Standard”Potential Controversy

Ethicon,As the medical surgical department under Johnson & Johnson, its Gynecare TVT™ series of products have been playing a significant role in treating female stress urinary incontinence (SUI).The product series, with its minimally invasive and highly efficient characteristics, has become a widely used treatment solution globally and is acclaimed as the "gold standard" for treating female stress urinary incontinence.

The Gynecare TVT™ series of products by Ethicon mainly include the following types:

▪ TVT（Tension-Free Vaginal Tape）: As a classic retropubic urethral suspension system, TVT effectively improves urinary incontinence symptoms by placing a polypropylene sling under the urethra to provide support.

▪ TVT Exact: As an improved version of TVT, TVT Exact is designed to be more precise, aiming to further enhance surgical outcomes and safety.

▪ TVT-O（Transobturator Vaginal Tape）: This is a transobturator urethral sling system. The sling is placed through the obturator pathway, effectively reducing potential complications associated with the retropubic approach.

▪ TVT Abbrevo: This is a shorter sling system designed for patients who require simpler surgical procedures.

These products are all made of polypropylene material.With excellent biocompatibility and long-term stability. The TVT series products have more than 20 years of clinical data support worldwide.Its efficacy and safety have been widely recognized.

Although the TVT™ series of products have achieved significant clinical results in the treatment of stress urinary incontinence, there are also some potential problems and controversies:

▪ Postoperative Pain and Infection: Some patients may experience pain, infection, or a foreign body sensation after the surgery. Although these symptoms are mostly temporary, they still require attention from both doctors and patients.

▪ Postoperative Sling ErosionIn extremely rare cases, the sling may erode into surrounding tissues, causing injury to the vagina or urethra. Although this situation is uncommon, if it occurs, surgical intervention may be required.

▪ Postoperative Urination Difficulty: A small number of patients may experience difficulty in urination or urinary retention. This may be related to the position of the sling or improper tension adjustment, requiring careful postoperative evaluation and management by the doctor.

▪ Mesh Material Issues：The long-term safety of polypropylene material has been questioned by some. Although the material performs well in biocompatibility and stability, some patients have reported mesh-related chronic pain and tissue reactions.

Due to the aforementioned complications, Ethicon's Gynecare TVT™ series of products have faced numerous legal lawsuits over the past several years, primarily involving issues such as product design defects, inadequate disclosure of risks, and postoperative complications. Below are the details of some of the related litigations:

▪ Judith Shears v. Ethicon, Inc. Case:

Judith Shears underwent TVT mesh implant surgery for stress urinary incontinence but experienced severe complications post-operation, including recurrence of incontinence, urinary tract infections, pelvic pain, frequent urination, and urgency. In 2013, Shears and her husband Gary Shears filed a lawsuit against Ethicon, alleging design defects in the TVT mesh and claiming strict product liability and negligent design. Although the Shears lost the case due to insufficient evidence, the verdict was overturned by the U.S. Court of Appeals for the Fourth Circuit, which ordered a retrial.

▪ Kentucky Litigation：

In February 2023, Ethicon paid $9.9 million to settle claims by the state of Kentucky that it failed to disclose risks associated with its transvaginal mesh devices.

▪ California Litigation:

Ethicon faced a lawsuit brought by the California government and was ultimately ordered to pay $302 million in compensation. In 2023, the U.S. Supreme Court upheld this ruling.

As of September 2024, approximately 95% of transvaginal mesh lawsuits have been resolved through settlements or jury verdicts, but some cases are still ongoing. The main allegations faced by Ethicon in these lawsuits include failure to adequately disclose product risks and violation of consumer protection laws. As of September 2024, there are still 27 Ethicon-related cases pending in the federal multidistrict litigation (MDL).

For years, vaginal mesh has been the subject of legal challenges. According to Drugwatch statistics, in the past decade, giants in the vaginal mesh field have paid out claims exceeding $8 billion (55.2 billion RMB), including Johnson & Johnson, BD, Boston Scientific, and Coloplast. These cases are still being resolved through settlement or trial proceedings.

Although Johnson & Johnson Ethicon has avoided further legal disputes through settlements in some cases, some cases are still ongoing.These lawsuits have not only imposed a huge economic burden on Ethicon. Will the sale of this product line help Ethicon start afresh? Can it confirm Caldera Medical's leading position in female stress urinary incontinence? Medical Device News will continue to follow up.

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