Re: Mirena and class action lawsuit
Mirena and class action lawsuit
The FDA website only lists 5 adverse events for this device in the past 4 years. In order to make an impact, FDA needs to be aware of these issues. Go to https://www.accessdata.fda.gov/scripts/medwatch/ and fill out as much information as you have. This company will never be held to task unless and until we speak up. We are thankful my wife's case was not as bad as some folks, but are still glad to have it out. If they are aware of the rate of devices penetrating the uterus and are not notifying FDA, they are violating federal regulations, and despite claims made here to the contrary, could probably be held liable for not adequately monitoring the safety of their product.
Anyone who has had a device migrate out of their uterus requiring surgery to correct should either insist that the hopital file a MedWatch report, or should file one themselves.
FDA is extremely short on resources and uses MedWatch reports to determine where to focus their efforts.
Food for thought from somebody who deals with FDA on a daily basis.