Over 3,200 were discovered to have experienced breakage of their Paraguard IUD, a non-hormonal form of birth control.
Evidently, the company knew of the issue and simply changed the label as complaints mounted.
Many women who still had the birth control were unaware that the IUD could break when removed.
One woman who kept her IUD in for the full ten years recommended by the FDA, did not know it could break until she went to have it removed. Upon removal, one of the arms broke off and was still in her uterus.
She said she had liked the idea of no hormones and that it could last for a long time, but if she had known it could break, she would have had it removed earlier.
The FDA adverse event reporting system shows that 3,290 women have reported breakage, 2,000 are listed as serious, and breakage is the fifth most common adverse reaction with Paraguard.
The maker started reporting the complaints in 2013 and by 2019 the number reached 2,500.
After this, the company only added the possibility of breakage under the Warning and Precautions section, nothing more. They did not notify women who already had the IUD in place that could face these complications unknowingly.
It is up to the company how they want to notify recipients of a drug about changes, and by updating their Warnings and Precautions which are publicly available, the FDA says that’s enough and no further studies are needed.
Some experts also say the instances of breakage are rare and the birth control is still safe to use.
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