This topic is about the 3D-Printed Titanium TIES Implant, a promising yet challenging innovation in ostomy care. The TIES system involves a titanium port implanted in the stoma, which is closed with a removable polymer lid. Here's a breakdown of the key points and insights shared:

- Initially, the prototypes for the TIES system were expensive and difficult to optimize. However, the switch to 3D-printed titanium in 2012 allowed for more complex designs, surfaces that encourage tissue growth, and reduced costs.

- The system has gone through four generations of lid designs:
1. The first generation was a simple cap.
2. The second generation improved the cap but required removal, and pressure could cause splatter.
3. The third generation included a cap with a hatch that opened into a bag, but it was still messy.
4. The current fourth generation combines the safety of the second generation with an opening accessible through a pouch, with lids that are reusable but need weekly changes.

- A pivotal clinical trial involved 20 patients across the UK, Sweden, Poland, Austria, and India. The six-month follow-up data will support the CE-mark submission under the EU MDR.

- Additional accessories are being explored to cater to different patient preferences.

A participant in a clinical trial reported a negative experience, where the implant led to complications such as leakage, lid failure, and necrotic tissue, resulting in the device's removal. They emphasize the importance of:

1. Testing the full system, including the implant and collection device, rather than individual components.
2. Securing and protecting funding for patient safety before conducting human trials.
3. Transparently sharing all patient outcomes, not just the positive ones, as an ethical necessity.

Additional insights include:

- OstomyCure has declared the TIES system unsuitable for individuals diagnosed with Crohn’s disease based on previous trial experiences.
- Trial data remains closed, preventing independent assessment.
- The TIES system requires further trials, CE-mark approval under stricter MDR rules, and eventual FDA review, meaning routine availability is still far off.
- Other concepts like the BCID and various aspiration/inner-pouch systems are further along but not yet mainstream or without issues.
- Achieving freedom from an external bag is rare, often temporary, and requires full informed consent.

Advice and insights for those considering such innovations:

- Ethical and legal safeguards should be in place, including compensation and ongoing support for trial participants who experience harm. Gagging clauses that prevent sharing adverse experiences should be banned to ensure transparency and benefit future patients.

- An external wafer and pouch system may be safer, as long-term implant failures show that internal solutions can deteriorate over time. External systems are visible and easier to monitor for issues.

- Despite promising engineering, the TIES system is still experimental. Prospective patients should manage their expectations and seek comprehensive, up-to-date information before participating in trials.