This topic has been mentioned before, about hospitals being reluctant to use
an object for some purpose other than the most common.  Now I am wondering:
what procedures are in place for approval of devices such as the Niplette,
which is simply a syringe with a nipple-shaped bell attached?  Does the
manufacturer have to show that they are both safe and effective, before they
can be sold to anyone who wants one?  They obviously don't have to do so for
nipple shields, which at least in Norway are sold with absolutely no
information about how to apply them correctly, or what indications they should
be used for, and what the contraindications and cautions are.  Would a
hospital that uses nipple shields for any reason, be worried that they are
liable if the shields lead to premature weaning, or mastitis, or ulcerative
lesions on the breast (all of which I have observed after what an IBCLC would
consider inappropriate use of shields - no follow up, no guidance, no
documentation)?  They should be, but I don't see them tightening up
availability of shields out there.  Guess as long as they are put on nipples,
it's nobody's responsibility whether the outcome is bad!
Single-use syringes are available without a prescription.  What instructions
come with them?  Any at all?  Does it say anywhere on the package that they
are only for use with hypodermic needles, so that you ought not to give babies
oral liquid medications with them either?
And why are these hospitals not worried about the use of potentially dangerous
drugs for other-than-approved uses?  Misoprostol is used to induce labor, even
though it is only approved for treatment of gastric ulcers, and the
manufacture has stated unequivocally that they accept no liability for
complications arising from other uses of the drug.
Are there any cases of uterine rupture and fetal death after using a syringe
as a home-made nipple everter?  I am just curious.
Rachel Myr

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