Granulomas;. Vascular Malformations; • Haematomas; and • Tumours of the pituitary gland or spinal cord.
Granulomas;. Vascular malformations;
Granulomas;. These are small bumps that could form around the foreign matter (the colorant).
Granulomas;. Malformations in the arteries or veins of the brain;
Granulomas;. Masses (lumps) in the skin and deeper tissues after a CaHA tissue filler injection are extremely rare. Should these occur, additional treatments including antibiotics or surgery may be necessary. Granulomas may produce scarring within the skin and deeper structures. Allergic Reactions and Hypersensitivity - It is unknown if CaHA tissue filler is associated with serious systemic anaphylactic allergic reactions. Accidental Intraarterial injection - It is extremely rare that during the course of injection, that tissue filler could be accidentally injected into arterial structures and produce a blockage of blood flow. This may produce skin necrosis in facial structures or damage blood flow to the eye, resulting in loss of vision. The risk and consequences of accidental intravascular injection is unknown and not predictable. informed-consent-calciumtissue fillers (caha) hydroxyapatite > Under/Over Correction - The injection of soft tissue fillers to correct wrinkles and soft tissue contour deficiencies may not produce the desired outcome. The amount of correction may be inadequate or excessive. It may not be possible to control the process of injection of tissue fillers due to factors attributable to each patient’s situation. If under correction occurs, you may be advised to consider additional injections of tissue filler materials. Over correction may require removal of tissue filler material. Additional Advisories Advisories for patients considering semi-permanent tissue filler injections: Off-label usage of XxXX- XxXX, depending on its manufacturer is labeled for specific use. The use of CaHA for other conditions and disorders would be considered “off-label” usage by your physician. FDA defines off label use as, “Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling.” The FDA recognizes that off label use of drugs by prescribers is often appropriate and may receive endorsement from published literature. CaHA may be used according to a physician’s practice to treat other conditions. Unsatisfactory Result - CaHA tissue filler injections alone may not produce an outcome that meets your expectations for improvement in wrinkles or soft tissue depressions. There is the possibility of a poor or inadequate response. Additional injections may be necessary. Surgical procedures or other treatments may be recommended in additional to tissue filler treatments. Unknown Risks - There is the possibility that ...
