Essure is a birth control implant intended to provide permanent contraception for women who are done having children. The system, comprised of two small coil implants designed to block the Fallopian tubes, is manufactured by the German multinational healthcare company Bayer.
Materials In Essure Linked To Allergic Reactions
Each implant is made from five materials, four of which are metals or metal alloys:
- Nitinol (nickel-titanium alloy)
- Polyethylene terephthalate (PET) fibers (Essure’s manufacturer, Bayer, refers to these as “polyester fibers”)
- 316L stainless steel
Tens of thousands of women blame their Essure implants for devastating side effects. Numerous reports of chronic pelvic pain, abnormal menstruation, excessive fatigue and migraine headaches have been submitted to the US Food & Drug Administration, leading the federal agency to dramatically strengthen the device’s patient and healthcare provider warning labels.
In addition to these debilitating side effects, many women believe that the materials from which Essure is made are causing their own problems.
Nitinol is an alloy of nickel and titanium, two chemical elements found in natural ore deposits around the globe. While nitinol was first developed by the Navy in 1959, the alloy’s unique properties have made it a common choice for many medical devices, including stents and replacement heart valves:
- Shape Memory – Nitinol changes shape along with natural temperature fluctuations inside the body, but can return to its original shape under certain circumstances
- Superelasticity – Nitinol devices display a remarkable elasticity, or “springiness,” between certain temperatures
Long-running debates in the medical community have raised serious concerns about the safety of nitinol, due in large part to the alloy’s considerable nickel content. Thousands of women claim to have experienced severe allergic reactions to the Essure device.
Nickel allergies are extremely common in the general population. In one Danish study, researchers discovered that up to 14.5% of the general female population may be allergic to the metal. Other estimates suggest lower, but still relatively high, rates of nickel allergy – between 8% and 9% of the female population, according to a team publishing in the medical journal Dermatitis.
With these statistics in mind, it’s not surprising that thousands of women have reported serious side effects of a nickel allergy after receiving the Essure implants:
Beyond allergies, exposure to nickel compounds has been linked to an increased risk of lung and nasal cancers, the National Cancer Institute reports.
What Are The Symptoms Of A Nickel Allergy?
In our own analysis of Essure adverse event reports, which reviewed nearly 10,000 reports submitted to the FDA between November 4, 2002 and January 1, 2016, our attorneys identified 1,778 mentions of hives and rashes, common symptoms of a nickel allergy.
Here are 5 common symptoms of nickel poisoning to look out for. Symptoms generally begin soon after contact with nickel and can last between two to four weeks.
- Urticaria (Hives – a skin rash) – outbreaks of small, pale-red bumps that appear suddenly on the skin. Hives can be itchy, or can be accompanied by a burning or stinging sensation.
- Angioedema – a form of swelling similar to hives, but one that appears below the skin. Angioedema usually begins around the eyes and lips, according to the US National Library of Medicine, but can also be found on the hands, feet or throat.
- Facial edema – swelling on the face, usually noticeable on the lips, cheeks and eyelids. Caused by a buildup of fluid or inflammation, facial edema can be painful. Severe swelling can block the airways and lead to difficulty breathing.
- Pruritis – itchiness on the skin, which may or may not be accompanied by redness, bumps or fluid-filled blisters.
- Patches of dry skin
Keep in mind that Essure’s significant nickel content may not just be aggravating pre-existing nickel allergies. In fact, as the birth control implant’s new FDA-approved labeling suggests, “some patients may develop an allergy to nickel or other components of the insert following placement.”
Can Essure Cause New Allergies To Nickel?
Recent research, however, has found mixed evidence that Essure can increase a patient’s sensitivity to nickel. In one small trial published by the Journal of Minimally-Invasive Gynecology, a group of researchers from the Netherlands found no statistically significant increase in allergy-related symptoms among Essure patients. That study, though, was extremely small, including only 169 patients, and should not be considered definitive evidence for any conclusion.
More research is needed to determine whether or not Essure can cause nickel allergies in patients who were previously unaffected by this problem. At the same time, Bayer, Essure’s manufacturer, specifically warns women that they may develop nickel allergies after having the birth control device implanted.
Bayer Admits Nickel Allergy Risk
In the implant’s new Patient Decision Checklist, a pamphlet of risk information designed to inform prospective patients, Bayer writes, “the Essure implants contain metals including nickel, titanium, iron, chromium, and tin, as well as a material called polyethylene terephthalate (PET).” The pamphlet goes on to inform patients that “some women may develop allergic reactions to the device following implantation.” Some women “have signs or symptoms such as rash and itching,” the Bayer-drafted document continues: “this may occur even if there is no prior history of sensitivity to those materials.”
Polyethylene Terephthalate (PET)
Polyethylene terephthalate, or PET, is a form of polyester, a family of plastics that can be either natural or synthetic. Most of the world’s PET is synthetic, used most notably to manufacture plastic bottles and clothing.
In the Essure implants, PET fibers are intended to create a controlled inflammatory reaction, forcing the production of scar tissue and thus blocking off the Fallopian tubes. While PET is widely used in commercial applications, the material may come with several significant health risks. As the fibers degrade, they produce a chemical called acetaldehyde, which has been associated with several debilitating medical conditions, including the liver diseases that often affect alcoholics.
Stainless steel is a form of steel alloy with a high proportion of the chemical element chromium. Unlike other types of steel, stainless steel does not readily corrode, rust or stain in the presence of water. Stainless steel may be one of the most common materials used to create medical instruments, including surgical tools and implantable devices.
Nickel can also be found in high amounts in many versions of stainless steel. The specific form of stainless steel used in the Essure implants, called 316L stainless steel, brings with it notable benefits in corrosion resistance, but can also have a relatively high nickel content. As AK Steel, an industrial manufacturer based in Ohio reports, 316L stainless steel can include between 10% to 14% nickel.
Platinum is a rare chemical element characterized by its density, malleability and resistance to corrosion. Used frequently in dental implants and as a component in some medical devices, platinum is generally considered non-toxic at low exposure levels.
In the Essure system, platinum has been used to create a “marker band,” which allows physicians to gauge their process during the implantation procedure. Specifically, the platinum band marks the end of the implant’s Nitinol outer coil, as described in Essure’s instruction manual for physicians.
Another alloy, silver-tin, is used as a solder in the Essure implants. After being melted, using either heat or ultrasonic technology, the alloy hardens to create a permanent bond between other pieces of metal. Silver-tin is the most commonly-used solder material in electronics applications, and also makes its way into many medical devices.