Medical devices are composed of a vast and complicated field. Therefore they range from a scalpel to the pacemaker. As per the FDA definition, medical devices are apparatus, machine, contrivance, in vitro reagent, implements, and implants. FDA is the body responsible for certifying various medical devices so that they can be released to the market. However, some manufacturers manipulate the data on the effectiveness of their devices leading to the approval of substandard devices. This means these devices have not met all the regulations to be released which leads to medical negligence.
Essure is a form of a contraceptive medical device which is meant to sterilize women. The device was brought to the market by Bayer AG’s subsidiary Conceptus. The two coils in the device are inserted in the fallopian tubes thus preventing fertilization from taking place. The main reason for the development of this device was to produce a less invasive form of tubal ligation. Unlike the normal tubal ligation where you have to go through major surgery, Essure can be implanted in without going through major surgery.
The Insertion Procedure
Essure insertion is a quick procedure which is done under local anesthesia. During the procedure, the devices two coils are inserted into the fallopian tube through the birth canal. Once they are implanted the prompt tissues to grow around them till they block the fallopian tubes, it takes about three months for the tissues to block the fallopian tubes thus preventing fertilization completely. Since its take about three months for the implant to be effective, you have to make regular medical follow up with your doctor.
The Genesis of Essure Lawsuits in 2019
The FDA approved this device in 2002. As soon as the product hit the market, some women who implanted it started complaining about pains and even getting pregnant. Though these conditions were rare, the product seemed to be effective until 2009. The problems began when its manufacture started selling its effectiveness and safety. At this time it was evident that the implant was causing persistent bleeding and pain, unwanted pregnancies, and even some deaths were suspected to be related to this implant. Later consumers started complaining about the procedure through which the product was approved. By 2013 there were numerous complains about the side effects of Essure. An equal number of lawsuits followed this.
The Essure Lawsuits
Most of the lawsuits filed against Conceptus were claims for compensation due to the harm caused by the implant. The lawsuits were under the allegations that the company didn’t disclose the potential side effects of implanting the devices. There were also claims that the device was woefully approved. Later there were hundreds of lawsuits claiming that the implantation of this product is medical malpractice since they hid some information about Essure. By now FDA has received over 10,000 medical reports about this device.