The Food and Drug Administration has apparently declared that Bayer would be required to curtail the sales of its popular birth control implant – Essure. The product sale restriction is liable for medical practices such as physician’s offices that technically agree to keep their female patients thoroughly informed about the device’s risks.
As per reliable reports, Essure comprises two small coils that are made of a polyester-like fiber and a nickel alloy and is placed through the vagina in the fallopian tubes. The device is apparently designed to generate an inflammatory response leading to the formation of a scar tissue that blocks the tubes. Launched in contraceptives market by Bayer more than 16 years ago, Essure created a negative spate of sorts soon post its introduction.
As per sources, the last one and half decades have witnessed Essure going downhill, as thousands of ladies have sued Bayer on the grounds of suffering numerous injuries, such as perforation of the fallopian tubes and uterus due to the implant. Back in the day, the FDA had received more than 26,000 cases of mishaps due to the device, that severely crippled Essure’s repute in contraceptives industry.
In response to the complaints received, the FDA, around a couple of years earlier, had decided to place a ‘black box warning’ on the package that warned patients about the type of injuries the device may cause. Additionally, the notice stated that it is likely for the implant to travel into the pelvic cavity and the abdomen.
At present however, the FDA has declared that doctors would need to make sure patients sign a designated form with a checklist. The acknowledgement, complete with the doctor’s signature, apparently states that patients are completely aware of the risks of the product.
Chemical major Bayer, refusing to accept Essure’s deteriorating popularity in contraceptives market, claims that it had already issued a warning label for the device. Essure’s benefit is still the same, it states, and it is the duty of the primary physician to discuss medical risks with the patient.