information on safety
Although experience has been reassuring, FertiGen represents an exciting new field where long-term safety studies are pending.
But because PRP has already been used in other medical settings with no reported adverse events, your growth factors should remain safe when used in the ovary, too.
Comfort also comes from the fact that PRP is obtained from the patient’s own platelets. Sorry, drug companies.
In other words, these growth factors are always autologous (i.e., from your own body) and processed fresh, instead of being made synthetically at industrial scale, frozen, packed or shipped away for off-site use.
OK, but what about long term risks for tumor or ovarian cancer later?
There is no evidence suggesting that platelet-derived growth factors increase subsequent risk of developing cancer or any other cell pathology in tissues where it is used — including the ovary.
Why not? Because receptors relevant in PRP treatment are at cell (surface) membranes, not the nucleus. So unlike hormones and sex steroids such as estrogen & progesterone which may increase rate of malignant (nuclear) transformation in some women, this effect cannot occur with PRP since the site of its cellular action is different.
W A R N I N G S: FertiGen is unsafe & not suitable for women who are smokers, hemodynamically unstable, immunologically compromised, morbidly obese, or have any uncontrolled chronic medical condition, gynecological pathology, or any platelet dysfunction syndrome.
FertiGen patients must not use aspirin or any NSAID within 10 days of the procedure. Medication in the aspirin group blocks basic platelet function and must be avoided to optimize response. If there is any doubt that your ovaries cannot be seen/accessed by transvaginal ultrasound, you are not a good candidate for this procedure (FertiGen uses a vaginal approach for ovarian injection).
F D A information (USA)
PRP systems used in the United States require FDA clearance or approval under at least one clinical setting. Thus before any PRP kit can be sold or used in USA, manufacturers must obtain regulatory approval for some specified therapeutic application.
Physicians may use these products responsibly, even if the application falls outside the designated approval by FDA. In IVF practice, such a practice is routine and is known as “off-label” use.
Because FertiGen does not involve donor tissues or cells or synthetic compounds for transfusion, the FDA has not initiated any rules or regulations requiring approval for this or any other PRP therapy.
U.S. Code of Federal Regulations (CFR) Title 21 is germane to FertiGen although the policy exempts our fresh autologous platelet derived growth factor processes, as noted here: Subchapter F [Biologics] Subpart D [Plasma] 640.34.2.