IUDs Not Approved by the FDA implanted in over 400 patients by OB-GYN Associates in Rhode Island and Massachusetts
Posted Jun 28 2010 6:39pm
This will be interesting to follow up and see what arises when they are done as the IUDs were purchased at half the cost of what ones here in the US cost; however they are approved for use outside the US, so this is not a product that has not been reviewed and there appears to be no real danger.
What is interesting is the billing aspect of all of this too, as the article states they were billed as they were the product purchased here in the US and they were half the cost so were they looking to make money at this or was it just an honest mistake? Obviously the cost issue is there, but by the time a seasoned biller gets the paperwork, it could be a legit mistake too with billing as she/he normally does. BD
If you had an IUD implanted by OB-GYN Associates, located in Rhode Island and Massachusetts, contact your doctor to find out what type of IUD you have.
The medical group has been cited by the Rhode Island Department of Health for purchasing and implanting unapproved versions of both ParaGard and Mirena IUDs.
There is apparently no reason to worry about safety if the IUD. However, they were purchased internationally and not approved for use in the United States.
The Rhode Island Department of Health issued a press release stating that they discovered that the Rhode Island offices of OB-GYN Associates, Inc. have been purchasing non-US Food and Drug Administration (FDA)-approved versions of the Mirena and ParaGard intrauterine devices (IUDs) from a source also not approved by FDA.