Essure is a relatively new form of permanent contraception. If a woman decides, or is forced to decide for medical reasons, she no longer wishes to conceive a child, there are various temporary and permanent solutions. The first form of female birth control approved by the U.S. Food and Drug Administration (FDA), which saw widespread use, was the contraceptive pill or simply “the pill” as it is better known.
There are also several type of intrauterine devices (IUDs), which can be implanted into a female patient and will serve as a short-term or long-term birth control devise. Some are implanted into the arm of a patient. Some of these devises use medicines and others use metals such as copper, which can prevent an unwanted pregnancy. All of these devices have advantages and disadvantages, and some are riskier than others.
In addition to these temporary forms of birth control, there are permanent solutions, traditionally carried out through surgery. A female patient can elect to have her tubes tied to prevent pregnancy, or reproductive organs can be removed completely. This requires surgery and often, general anesthesia. There is also a radical hysterectomy, but that is much more invasive procedure that has additional complications.
Essure was marketed as a way for patients to have a permanent sterilization without the need for more invasive surgery. The devise is essentially a series of metal coils that are inserted into a woman’s Fallopian tubes. Once in place, these tubes will cause intentional scarring of the Fallopian tubes and soon make them non-functional. While this sounded like an ideal solution in theory for many women, as our Essure injury lawyers in Boston can explain, things did not go according to plan for many patients.
According to a recent news article from FOX 40, a new documentary on Netflix focuses on how Essure has put many patient’s at risk, and describes the trouble they have faced as a result of using what was marketed as a safe and minimally invasive alternative to more traditional surgical techniques currently being used. This documentary is called “The Bleeding Edge” and is currently on the online streaming service’s platform for viewing by millions of subscribers.
In this documentary, those featured alleged the company was able to rush the devices through the regulatory and application process at the U.S. Food and Drug Administration and get the device to market. The FDA is the federal agency responsible for oversight of the pharmaceutical industry and medical device industry and requires all applicants to perform extensive testing during the application process. Unfortunately, due to decades of lobbying efforts by the pharmaceutical industry, these protections are nowhere near where they should be, and many potentially dangerous and defective drugs and medical products are able to make their way onto the market, where the drug companies can make billions of dollars. But this is often at grave risk to millions of Americans who are trusting their drugs and medical devices are safe.
It should also be noted that these companies are not only deceiving the FDA, they are not giving doctors relevant information as well. This means that even if a doctor is doing everything he or she can do to adhere to a high standard of care as required, there is often nothing to prevent this type of harm. This is why these are products liability actions and not medical malpractice actions, because there is often no fault being alleged on behalf of the doctors. However, it is possible there was fault committed by a doctor in addition to defects or inadequate warnings in the medical device, so it is best to speak with an experienced products liability attorney who also represents patients in Boston who have been harmed by defective medical products, medical error or other forms of medical malpractice.
One patient featured in this documentary was a mother of three, who was healthy before the implantation of an Essure device but suffered for five years after having the procedure performed. She suffered both physical harm and pain as well as emotional turmoil throughout her ordeal. At first doctors could not find anything wrong with her and she was being treated as if she was a hypochondriac. After years of suffering, they learned she was telling the truth.
Her symptoms included chronic pain, hair loss and extreme levels of fatigue. The metal coils that were inserted caused what she described as crippling pain. Many other women in the documentary suffered from insomnia from the pain, and other serious pain. These women formed a group for women who have suffered from Essure and want the device pulled from the market. There are now over 30,000 women who have joined this group.
The FDA has apparently bowed to pressure from the manufacturer as there is a lot of money at stake. While the FDA now admits there are some women who have suffered serious and debilitating problems as a result of having Essure implanted, the agency still contends the device is safe and effective for the majority of women who use Essure.
While the FDA is the agency in charge of whether Essure stays on the market, and whether Essure should have additional warnings to doctors and patients. This is not the final word on whether these patients can be compensated for their injuries, and whether the devices will be pulled from the market. As we have seen with other defective medical devises such as the metal-on-metal hip implants like the Pinnacle ASR, injury victims seeking justice can be a powerful motivator for pulling a product from the marketplace.
While documentaries can certainly go a long way in bringing awareness, as can advocacy groups and civil trial attorneys. If companies are forced to pay high verdicts in Essure lawsuits, that might eventually lead to them acting responsibly and taking the products off the market before women are needlessly harmed.
If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — (617) 777-7777.
Special Report: Netflix Documentary Exposes Dangerous Medical Device, According to Patients, July 15, 2018, By Ali Wolf, Fox 40
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Transvaginal Mesh Update: Boston Scientific Settles with 350 Plaintiffs, Feb. 11, 2018, Boston Product Liability Attorney Blog