I would like to add a little to the discussion regarding problems with breast
pumps. In the US, the FDA regulates breast pumps as medical devices.
Therefore, any problems with pumps should be reported to the FDA through its MedWatch
program at www.fda.gov. The problems should also be reported to the
manufacturer. The manufacturer is required to open a file on all complaints and deal
with them. We very much need to start reporting these adverse events. The pumps
coming onto the market for the most part are never clinically tested and simply
get to market by telling the FDA that the pump is similar to one already on
the market. This means that any plastic toy can be sold as a breast pump.

If we do not report these incidents to the FDA and the manufacturer, then
mothers will continue to be exposed to equipment that is either ineffective or
actually harmful. PLEASE report all of these incidents.

Marsha Walker, RN, IBCLC
Weston, MA

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