According to the FDA, the risks of using Essure include:
Short-term risks to patients reported in clinical trials include:
- During the Essure placement procedure and immediately following, some patients may experience mild to moderate pain.
- Immediately following the procedure, some patients may also experience cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort.
Long-term risks to patients reported in clinical trials include:
- Unintended pregnancy
- Abdominal, pelvic or back pain
- Perforation of the uterus or fallopian tubes
- Inserts found in the abdominal or pelvic cavity
Other reactions included in medical device reports submitted to the FDA include:
- Weight changes
- Hair loss
- Mood changes, including depression
- Allergy or hypersensitivity reactions
- Joint or muscle pain
- Muscle weakness
CBS New reports:
Tens of thousands of women say they suffered painful and serious side-effects from Essure, a medical device meant as a permanent birth control option. The device is the subject of nearly 27,000 complaints to the FDA since its approval in 2002. Women reported excessive pain, severe allergic reactions and, in some cases, perforated organs.
Essure is FDA approved, but the agency recently restricted sales of the device to physicians who provide their patients with a checklist outlining the risks, reports CBS News correspondent Anna Werner. The FDA also gave the device a mandatory black box warning in 2016.
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