The topic at hand is the OstomyCure Transcutaneous Implant Evacuation System (TIES®), which is a 3-D printed titanium port designed to replace a conventional stoma. This innovative system aims to offer a more discreet and comfortable alternative for ostomy patients. Here's how it works and some insights from discussions about it:
- The TIES port is designed to sit flush with the skin and is covered by a screw-in lid with a hatch. When it's time to empty, the lid stays on, the hatch is opened, and a disposable bag holder is attached and then removed after use. This design aims to provide freedom from wearing a permanent pouch, reduce noise and odor, and prevent skin problems around the stoma.
- However, there is limited real-world data available. Forum members have struggled to find independent patient testimonials, with only marketing materials and a couple of YouTube comments available. Additionally, the website link provided has been intermittently offline for some users.
- The TIES03 multi-centre trial began in mid-2019 in the UK and Sweden, with U.S. clinical studies planned for late 2023. The device is primarily aimed at ileostomy patients with conditions like Crohn’s disease, ulcerative colitis, or genetic disorders. In Sweden, only a small number of implants have been done, with some later removed due to complications.
- The first UK recipient of the device reported serious complications that required removal of the implant. The manufacturer is covering corrective surgery costs, and Crohn’s disease is now listed as a contraindication. This patient plans to share photos to highlight the risks and advises others to seek independent medical advice before considering the procedure.
- There are technical and safety concerns raised by forum members, including the use of a fine titanium mesh, potential for parastomal hernias, and doubts about the system's ability to eliminate the need for a bag. Concerns about the durability of the device during activities like exercise have also been mentioned.
- Leakage and skin issues have been reported, with unpublished study data indicating varying levels of leakage and skin irritation among test subjects.
- Access to information and transparency is a concern, with suspicions of nondisclosure agreements preventing trial participants from speaking publicly. Members stress the importance of seeking independent consultation and full disclosure of adverse-event data before considering surgery.
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