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Lactation Information and Discussion <[log in to unmask]>
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Wed, 24 May 2000 07:40:02 EDT
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Having read Barbara's report of the damage and problems caused by a breast
pump, I wanted to remind the list that in the US there is recourse regarding
ineffective or damaging breast pumps. Breast pumps are considered a medical
device and as such fall under the jurisdiction of the Food and Drug
Administration (FDA). The FDA has a system called MedWatch for reporting
problems with medical devices and nutritional products, including infant
formula.

If any of your mothers have experienced damage from using a pump this should
be reported to MedWatch. If any of your mothers have a pump that is
ineffective or if they have experienced therapeutic failures (loss of milk
supply), this too should be reported. You can download the reporting form
from the FDA's web site at www.fda.gov. Please consider filling out a report
each time there is a problem with a pump. This is the only way that the
regulatory agency has of learning what is really happening with this type of
product. Rep. Maloney has legislation submissions regarding breast pumps
also, which will never be passed unless the FDA has a base of information
regarding the problems encountered.

Any time a baby has problems with infant formula qualifies as a reason to
submit a report to MedWatch. As professionals, we have an obligation to
protect our mothers and babies from products that have the potential for
causing harm.

Marsha Walker, RN, IBCLC
Weston, MA

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