Essure: FDA “Pre-Market Approval” Strikes Again | Levin Papantonio - Personal Injury Lawyers

Essure: FDA “Pre-Market Approval” Strikes Again

Essure is a small coil made from the transition metal nickel, designed to be inserted into the Fallopian tubes in order to prevent conception. The device, developed by Bayer subsidiary Conceptus, Inc., was intended to be a less invasive alternative to tubal ligation. Unfortunately, it has been causing women to develop a host of health problems, including chronic pain, metal poisoning, auto-immune reactions, abnormal bleeding and even death.  As is far too often the case, growing evidence indicates that the manufacturer was aware of these dangers from the beginning – and yet, the Essure sterilization device was granted FDA approval in 2002.

The selling point of Essure was, as always, based on cost analysis. Tubal ligation, the traditional method of sterilization, is a major surgical procedure that requires the patient to be anesthetized and to remain in the hospital. Implanting Essure is a relatively minor outpatient procedure that can be done in a physician's office. As late as 2009, a review in the medical journal Fertility and Sterility indicated that Essure was a safe, effective method of birth control.  Recently, however, the FDA has been forced to acknowledge that, based on reports of adverse events and new evidence from the medical community, this is not the case.  Gynecologists and other medical professionals have expressed concerns that FDA approval of Essure was based on very limited, short-term clinical testing. During the original pre-market studies, fewer than 750 women participated. Only a quarter of these subjects were followed up over the next 24 months. One of the pre-market studies did not come out until recently, and another one has yet to see the light of day.

It begs the question of what Conceptus and Bayer have been hiding.

In October of 2013, the FDA finally acknowledged that since its initial approval of the Essure device, the regulatory agency had received a total of 943 reports of adverse events – in addition to as many as 1,000 complaints submitted through the FDA's voluntary reporting system.  Since it is a voluntary system and physicians are under no obligation to submit such reports, the number of adverse events may be much higher. A  group on the social media website Facebook, called Essure Problems, currently has almost 10,000 “likes” and nearly 25,000 members. The group reports problems that include breakage, organ perforation and stillborn children with the device embedded in them.

If Conceptus was aware of the dangers of this device, why was Essure given FDA approval based on such limited studies?

It has to do with what is known as “Pre-Market Approval.” It allows a pharmaceutical or medical device manufacture to bypass the normal, rigorous clinical studies if it can be demonstrated that the product in question is “substantially similar” to a product that has already been approved and on the market. Levin Papantonio attorney Travis Lepicier explains:

[The FDA] took the numbers that the manufacturer had presented to them in the pre-market approval process...they took them at face value, they didn't really look into them any further as far as the reports of pain that women were indicating in the initial studies when this product was first being looked at.”

Mr. Lepicier adds, “There was plenty of information out there that should have tipped the FDA off that this product was going to be problematic.”

There's an even more disturbing aspect to this “pre-market approval” (PMA). It was granted to Conceptus based on the claim that the company had adhered to rigid and rigorous research protocols – which shielded the manufacturer from legal liability. This has been challenged, however, as evidence now strongly indicates that the company's research did not in fact adhere to said protocols, and was performed in a hurried and slipshod manner. This puts Conceptus in violation of the conditions under which Essure's PMA was granted – and has opened the door to litigation against the company.