The Food and Drug Administration (FDA) will be reviewing the safety of birth control Essure after a string of complaints regarding the device.
The sterilization implant has caused a growing number of women a series of bad reactions, such as persistent pelvic and abdominal pain, nausea, fainting and bleeding.
In the last 4 years, the number of negative side-effects associated with the sterility device has surged, reaching now a value 20 times higher than before. As a result, the FDA has scheduled a public hearing for September 24, which requires the participation of customers who have used Essure and have suffered complications.
The permanent birth control device was approved by the federal agency in November 2002, and initially there were no reports questioning its effectiveness, quality or safety. It was actually claimed by two separate studies that the product was more cost-effective than laparascopic tubal ligation.
Bayer HealthCare Pharmaceuticals eventually acquired Conceptus, the company which developed Essure, in 2013, following the device’s success. Around 750,000 women have been using the sterilization implant all over the world, and approximately a million products have been sold so far, mostly in the United States.
Nevertheless, recently there has been a surge in complaints against the birth control implant, and Bayer is now being faced with several lawsuits. Company representatives insist that the women who have experienced negative reactions to the sterilization product represent just a small percentage of its total users, and therefore its benefits surpass its potential risks.
They maintain that the product isn’tt defective and there’s no need to take it offf the market. They also suggest that the device must be inserted properly for it to function correctly: the procedure takes around 10 minutes and must be performed by a medical practioner.
Essure contains nickel and is inserted with no general anesthesia or incision, into the fallopian tubes, where it stimulates tissue growth that acts as a barrier against sperm.
Although Bayer suggests that the procedure is 99.74% effective and safe for the patients, the FDA announced in June that more than 5,000 complaints were filed against the device. It appears that 7 women have died after getting the birth control implant and hundreds of others reported severe adverse reactions and complications.
A Facebook support group called “Essure Problems” already has more than 20,000 members, and a citizen’s petition submitted in January raised more than 2,100 signatures asking for the device to be removed from the market.
So far, the agency has reviewed former studies concerning the birth control implant and has found little evidence of widespread complications associated with it. However, it did add extra warnings that the device isn’t recommended for women who are sensitive to nickel and that there is a risk of chronic pain, and even the possibility of pregnancy.
Experts from the Obstetrics and Gynecology Devices Panel will continue monitoring the product, to ensure that the risks are indeed minimal and that women can use it without endangering themselves.
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