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Warnings & Recommendations

The Pectus Up Surgery Kit provides the surgeon with a surgical method to treat Pectus Excavatum. The device is not intended to replace chest wall structures. While the device is intended to enlarge the chest cavity by eliminating the features of the deformity, it is impossible to determine in advance the extent of the change in structure in each case that may occur initially or permanently.

Prior to surgery, the surgeon must have comprehensive knowledge of the implant (Pectus Up) and the surgical procedure (Taulinoplastia).

  • It is important to choose and correctly position the implant.
  • The procedure requires specific pre-operation planning to identify the size and most suitable final position of the implant.
  • Avoid perforating the xiphoid process, otherwise there will be insufficient screw-xiphoid process gripping strength to enable the lifting process.
  • While the implant is mechanically fixed (screwed to the sternum), it is necessary to ensure the its central hole is flush with the hole in the sternum and that its edges are properly supported on the ribs.
  • It might be necessary to use a second lifting point or to position a double elevation implant should suitable alleviation of the deformity not occur.
  • While positioning the implant during the surgery, it is necessary to work with great precision to ensure the screw does not penetrate beyond the sternum.
  • When thinking about removing the device, the surgeon must consider the risks of not doing it at the right time.
  • This procedure to remove the device should be followed by post-operation observation to monitor for possible deformity recurrence.
  • Where the desired change is not observed, the device should then be removed.
  • Should the deformity reappear, a secondary or alternative treatment might be necessary.
  • SURGICAL IMPLANTS SHOULD ONLY BE USED ONCE. They may have imperfections, defects or worn out areas internally which could lead to fracturing or not performing correctly