Caldera Medical is a medical device company focused on women's health, founded in 2002 and headquartered in California, USA. The company is dedicated to developing, manufacturing, and selling top-tier minimally invasive surgical products for the treatment of stress urinary incontinence, pelvic organ prolapse, polyps, and uterine fibroids, among other gynecological conditions. 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 announced that it has officially acquired Ethicon's Gynecare TVT™ product line on March 20, 2025, and will complete the product transition in the coming months.

TVT™ product line includes TVT, TVT Exact, TVT-O, and TVT Abbrevo, which provide 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 manufacturing teams for the TVT products. This ensures a seamless transition for surgeons, patients, and partners, as the life-changing outcomes are backed by the same manufacturing processes, materials, and expertise. With over two decades of clinical data, including 20-year follow-ups on patients, the reliable performance and efficacy of TVT remain unchanged.

Caldera Medical CEO Bryon Merade said: "This acquisition marks a significant step in our mission to transform women's health. Incorporating the TVT product line into our portfolio reinforces our strong commitment to providing safe and effective solutions for surgeons and their patients. We are honored to continue the legacy of this product line and expand its reach, offering proven treatments to more women globally."

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 the proven success of TVT further solidifies its position as a leading provider of advanced solutions for women.

Before this acquisition, in September 2023, Caldera Medical acquired Atlantic Therapeutics and its Innovo non-invasive solution for treating bladder leakage, and in October 2024, it acquired UVision360 and its Luminelle product line for hysteroscopy and cystoscopy. These acquisitions not only accelerated the development of Caldera Medical but also demonstrated its commitment to expanding access to life-changing treatments, backed by a legacy of clinical success and a focus on improving patient outcomes.

Ethicon, as the medical and surgical division of Johnson & Johnson, has played a significant role in treating female stress urinary incontinence (SUI) with its Gynecare TVT™ series of products. This series, known for its minimally invasive and highly effective characteristics, has become a widely used treatment solution globally and is hailed as the "gold standard" for treating female stress urinary incontinence.

Ethicon's Gynecare TVT™ series of products mainly includes the following:

▪ TVT (Tension-Free Vaginal Tape): As a classic retropubic urethral suspension system, TVT provides support to the urethra by placing a polypropylene tape under the urethra, thereby effectively improving symptoms of incontinence.

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

▪ TVT-O (Transobturator Vaginal Tape): This is a transobturator urethral suspension system that places the tape through the obturator path, effectively reducing the complications that may arise from the retropubic approach.

▪ TVT Abbrevo: This is a shorter sling system designed for patients requiring a simpler surgical procedure.

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

Despite the significant clinical effectiveness of the TVT™ series of products in treating stress urinary incontinence, there are also some potential issues and controversies:

Postoperative pain and infection: Some patients may experience pain, infection, or a foreign body sensation after surgery. Although these symptoms are mostly temporary, they still need to be taken seriously by both doctors and patients.

Postoperative sling erosion: In very rare cases, the sling may erode surrounding tissues, leading to vaginal or urethral damage. Although this situation is rare, if it occurs, surgical intervention may be required.

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

Mesh material issue: The long-term safety of polypropylene material has been questioned. Although the material performs well in terms of 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 multiple legal lawsuits over the years, mainly involving issues such as product design defects, inadequate disclosure of risks, and postoperative complications. The following are details of some related litigations:

Judith Shears v. Ethicon, Inc. case:

Judith Shears underwent TVT mesh implant surgery for stress urinary incontinence, but experienced severe complications after the operation, including recurrence of urinary incontinence, urinary tract infections, pelvic pain, frequent urination, and urgent urination. In 2013, Shears and her husband Gary Shears filed a lawsuit against Ethicon, alleging that the TVT mesh had design defects, and made claims for strict product liability and negligent design. Ultimately, the Shears lost due to insufficient evidence, but after the case was appealed to the United States Court of Appeals for the Fourth Circuit, the court overturned the original verdict and ordered a retrial.

Kentucky litigation:

In February 2023, Ethicon paid a $9.9 million settlement to Kentucky to resolve claims that it failed to disclose the risks of its transvaginal mesh devices.

▪ California litigation:

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

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

For years, vaginal mesh has been the subject of legal challenges. According to Drugwatch, in the past decade, the amount of claims paid by giants for vaginal mesh has exceeded $8 billion (55.2 billion RMB), including companies such as Johnson & Johnson, BD, Boston Scientific, and Coloplast. These cases are still being resolved through settlements or trials.

Despite Ethicon's efforts to avoid further legal disputes by settling some cases, there are still a number of ongoing lawsuits. These litigations not only impose a significant economic burden on Ethicon, but also raise questions about whether the sale of this product line will help Ethicon move forward with a lighter load, and whether it can confirm Caldera Medical's leading position in female stress urinary incontinence.器械之家 will continue to follow the developments.