The FDA sent a warning letter to the president of Medela, Carr Lane Quackenbush, saying that an October 2010 visit to their facilities found them not in compliance with certain federal regulations, including but not limited to not taking proper action to correct and prevent issues with their Pump in Style Advanced pumps that are losing suction.
Ahem. Carr Lane Quakenbush. Real name. Serious face here. *deep breath*
Aside from those issues, there's also a problem they're not addressing with the pumps catching fire and hurting moms.
The letter from the FDA points out their violations, which includes "failure to adequately establish and maintain procedures for implementing corrective and preventive action." One of the complaints that apparently has not been addressed according to regulations?
Fourteen Pump in Style Advanced electric breast pump complaints document motors and transformers smoking or catching fire.
The letter goes on and on in legal jargon, pointing out that there are steps that are supposed to be followed, including gathering all complaints and figuring out why proper information isn't taken when complaints are filed, nor creating any plan of action and timeline for actually fixing these problems. They failed to report a product that reasonably can be considered potentially damaging or deadly, and didn't address how, if at ALL, Medela handled the pain and injuries reported with one of the fiery pump complaints that was filed, despite the mom needing pain medication and antibiotics. They also deny that pumps can cause mastitis (which a poorly-fitting pump or one used incorrectly can) and even told the mom, contrary to medical fact, that her mastitis did not need treatment! GRR!
The FDA letter also claims Medela doesn't maintain good enough records to show that past products fit regulations as well, and that they didn't look over anything beyond the current complaints nor at past designs to see if the complaints existed there either. There's more to it, but that's the general gist.
It's the FDA versus Medela, with many complaints from moms in the FDA's corner. Medela is a major company within the pump game -- they're in many box stores, readily-available for moms who need a high-quality pump with lots of custom parts for full-time pumping. While other companies are out there, like Ameda and Hygeia, which (some believe are) superior products for less cost. But because of availability and advertising budgets, it can mean many moms don't know about them. The Pump in Style is a favorite among MANY working moms, despite many faults the pump has including the fact that it's non-WHO Code compliant. It's frustrating. The big question is what will Medela do now to prove they are listening to customer complaints and making things better their top priority?
Does this info on Medela worry you?
Image via Amazon.com