With FemTech aggressively taking center stage, we may be on the verge of a women’s healthcare revolution. From 3D-printed pessaries to minimally invasive processes, we can expect a medical renaissance in the future. To give an insight into the context, this blog explores cutting-edge alternatives for treating pelvic organ prolapse and stress urinary incontinence.
Understanding Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP) is a condition marked by descending pelvic organs like the rectum, bladder, or uterus. This causes a bulge in the vagina, primarily because of weakened supporting tissues. Key factors that contribute to POP include:
- Childbirth: Especially multiple or difficult births.
- Aging: Natural loss of muscle tone and strength.
- Menopause: Lower estrogen levels affect pelvic muscles.
- Chronic Pressure: Caused by activities such as persistent coughing or heavy lifting.
- Obesity: Excess weight that puts pressure on the pelvic organs.
POP symptoms can include a feeling of pressure in the pelvic area, discomfort during sexual activities, and urinary complications.
Traditionally, POP and stress urinary incontinence (SUI) were treated with surgical mesh devices such as transvaginal mesh or pelvic mesh. However, these treatments, particularly transvaginal and pelvic mesh implants, are linked to mesh erosion and severe complications.
The Drive For Improvement In POP And SUI Treatment
A high-profile lawsuit helped fuel a desire to effectively manage POP and its associated symptoms while minimizing negative consequences. It led to treatments prioritizing patient safety and comfort without the disadvantages previously associated with mesh devices.
The Infamous Mesh Transvaginal Mesh Lawsuit
The vaginal mesh lawsuit is one of the most significant mass torts in history. The lawsuit highlights the traumatic consequences of transvaginal mesh complications. Women faced a range of severe consequences, including:
- Vaginal mesh injuries: These include mesh erosion, organ perforation, recurrent urinary tract infections, and mesh pain.
- Vaginal scarring: A distressing outcome that has an impact on one’s quality of life and well-being.
- Pain during intercourse: A sensitive issue caused by complications associated with mesh implants.
These allegations have targeted vaginal mesh manufacturers, including Johnson & Johnson and its subsidiary Ethicon, Coloplast, and Boston Scientific.
TorHoerman Law states that vaginal mesh usage has sparked considerable debate within the medical field. In response to the arising disputes, the multidistrict litigation panel has played a key role in overseeing vaginal mesh cases. The efforts have led to settlements with several mesh manufacturers. Despite these developments, a significant number of lawsuits remain active.
FDA’s Response To Mesh Treatments In POP And SUI
The FDA is actively committed to ensuring women’s health and access to safe, effective medical devices. The focus is on the benefit-risk analysis of certain urogynecologic surgical mesh devices. Their efforts include reviewing published literature, adverse event reports, and postmarket data. Besides, they are also involved in conducting research on the safety of surgical mesh for SUI and POP.
Furthermore, the FDA collaborates with professional societies to understand the postmarket performance and potential adverse event risks of these devices.
In recent activities, on October 17, 2022, the FDA released the results of the Coloplast Transvaginal Mesh for POP study. Despite the discontinuation of Coloplast devices for transvaginal POP repair, the FDA mandated ongoing patient follow-up.
Similarly, on August 16, 2021, the FDA reviewed the final results of Boston Scientific’s Transvaginal Mesh studies for POP. Like Coloplast, Boston Scientific’s devices for this purpose are no longer available. Yet, the FDA required patient follow-up in their 522 studies.
The study’s results, which compared the mesh to native tissue repair, showed similar safety and effectiveness at 36 months. However, the FDA finds that these devices present additional risks. It involves mesh exposure and erosion, leading to the conclusion that they do not have a favorable benefit-risk profile.
New-Age Treatments for Pelvic Organ Prolapse
Recent advances in the treatment of POP and SUI have emphasized minimally invasive, effective, and patient-friendly approaches. Notable advancements in this field include:
FemTherapeutics’ 3D-Printed Pessaries
FemTherapeutics has pioneered POP management with customized, biodegradable, and disposable intravaginal prosthetics. These pessaries, made with 3D printing technology and medical-grade silicone, are tailored to individual vaginal measurements for maximum comfort. This innovation overcomes the disadvantages of traditional pessaries by providing a sanitary, disposable option. It aims to reduce the risk of infection and discomfort.
Escala Medical’s Mesh-Free Repair System
The FDA’s approval of Escala Medical Ltd.’s mesh-free, non-surgical repair device represents a significant advance in POP treatment. This system uses sutures anchored to pelvic floor ligaments in an incision-free procedure. The end result is to offer a less invasive alternative to traditional surgical methods while also addressing associated concerns.
BioAesthetics Corp.’s Acellular Biologic Graft
BioAesthetics Corp. is working with Tulane University to develop an innovative graft for POP treatment. This acellular biologic graft, reinforced with biodegradable and biocompatible polymers, provides a safer and more effective alternative to surgical approaches. It is examined based on its elasticity, strength, and healing ability.
Transvaginal Percutaneous Hysteropexy Techniques
Less invasive POP treatment is now possible. Thanks to advancements in devices and techniques, such as the EnPlace system and the Escala. These techniques enable transvaginal percutaneous hysteropexy procedures to be performed as outpatient services using IV sedation and local anesthesia. This reduces the risk and morbidity associated with standard surgical procedures. Hence, it’s a safer option, especially for elderly patients.
How Do These Compare To The Vaginal Mesh?
3D-printed pessaries, mesh-free repairs, and biologic grafts offer notable benefits. Devices like EnPlace and Escala improve upon common vaginal mesh treatments for SUI and POP.
- Reduced complications: They reduce the risks of infection, tissue damage, and mesh erosion.
- Customization and comfort: 3D-printed pessaries offer personalized and comfortable options.
- Minimally invasive: They require fewer invasive procedures, lowering the risks linked with surgery.
- Regulatory compliance: They address concerns about mesh safety.
- Improved patient experience: Given the utility of these innovations, they improve the overall quality of patients’ lives.
In regard to the serious complications of pelvic mesh devices, medical innovators are shifting away from traditional vaginal mesh. They are more inclined toward safer, more personalized, and more effective treatments for pelvic organ prolapse. This demonstrates a clear shift from accepting risks to prioritizing safety and efficacy in addressing these critical women’s health issues.