Looking at the history of surgically implanted medical devices i.e. neurostimulators and intraocular lens, it is safe to assume that these devices have revolutionized the medical field.
However, if we look at the recent trend, some of these devices have backfired. In other words, they have done more harm than good to the patient’s body. One of the companies that belong to the latter category is Essure. Its birth controls system has resulted in more enemies than friends.
How Essure functions?
Essure is famous for its birth control system. Being an alternative form of sterilization, the birth control system is manufactured in the form of two stainless steel coils. These coils are then inserted into the fallopian tubes to prevent pregnancy. According to an estimate, more than 750,000 women have used the aforementioned method to prevent pregnancy.
One of the many reasons for the worldwide success of the Essure birth control system is its utility. Being described as a fast procedure, the Essure birth control system takes only 10-minutes to complete. Moreover, there is no need for providing anesthesia to the patients as the whole procedure is pain-free.
After the coils have been inserted in the vagina, they expand to a length of about 1.5 inches after which they attach themselves to the wall of the tubes. This process is so normal that no bed rest is recommended for the patients after the procedure.
Why is Essure under criticism?
Contrary to the aforementioned explanation, not all the women who have undergone the procedure give it full marks. As our body is sensitive to external intrusions, some women have complained that their body has reacted badly to the insertion of these coils.
In those cases where the body has reacted strongly, the women were subjected to a migraine, hair loss or perforation of the other organs of the body. In other cases, when the coils aren’t properly aligned with the body of the patient, the surgeon might have to take a second attempt to go through with the task.
Yet, in other cases, several women have reported that after undergoing the procedure, their menstrual cycle has changed dramatically. However, the worst possible disadvantage of Essure birth control system is yet to follow.
According to experts, this is a one way street with no looking back. For example, the intervention of Essure birth control system is an irreversible process. In other words, women cannot have children even if they want after undergoing the procedure.
In addition to the damage caused by these devices, one thing that infuriated the patients more was the firewalls that Essure erected around it to save the company from litigation. For example, if you’re a patient in whose body an Essure device has malfunctioned, you cannot sue the manufacturers of the company. Thus, while you could sue the device and get damages, the real culprit will remain unharmed.
How the lawmakers have responded?
Thus, in light of the above-mentioned disadvantages of Essure, it seems appalling that, for the victims of this procedure, they couldn’t sue the makers.
However, thanks to the members of Congress, the whole scenario could change in the upcoming months. Complying with the public demand, the lawmakers have argued that it seems crazy that a company couldn’t be held liable when one of its products has backfired.
“Every once and a while there’s a medical device that will get approved through either a fast track approval or a more rigorous approval that may do more harm than good — and that’s what we’re here to talk about,” said U.S. Rep. Mike Fitzpatrick, a Republican from Pennsylvania.
The first time the disadvantages of Essure surfaced was three years ago. Since then, according to a conservative estimate, more than 25,000 women have voiced their concerns regarding the procedure.
Why Essure cannot be sued under the present legislature?
While the question seems complex, the answer is simple. The birth control device of Essure was approved by the FDA years ago. At that time, looking at the track record of its manufacturer, FDA decided to grant a pre-emption status to Essure.
A pre-emption status is granted by FDA when it wants to shield a company from tort claims relating to products that have been approved by it. While this is a highly controversial issue, this law finds its relevance in cases like these.
Thus, no matter how much damage a medicine has inflicted on patients, get a pre-emption status and you cannot be sued by the patients. However, thanks to the efforts of lawmakers like Fitzpatrick, such legislation has now been introduced in front of the Congress that will change this law and allow patients to fill lawsuit against essure.
This new legislation will not only give the patients a right to sue the company, but it will also change the way medical devices are reviewed. Hence, as for patients who have suffered long and hard, this is a win-win situation for them.