So far, only a few Essure lawsuits have been filed and attorney Max Kennerly does not expect any of the cases he is working on to get near a courtroom any time in the near future.
For confidentiality reasons he won’t discuss any of the cases in detail.
“I can say these cases involve a lot the standard complications, not to diminish the severity of those complications,” says Max Kennerly from Kennerly Loutey in Philadelphia, Pennsylvania.
“You have a lot of women where the device has caused perforations in the fallopian tubes, there are a lot of cases where the device has migrated and shifted to other parts of the body, and there are women with allergic reactions. You have a lot of internal injuries where the Essure is not staying in place or reactions to the presence of nickel in the area.”
Bayer’s Essure contraceptive device first came on the market in 15 years ago and offers women an inexpensive, highly effective, permanent method of birth control.
A stainless spring, about an inch and a half long, coated in polyethylene terephalate is inserted through the vagina, through the cervix and placed inside the fallopian tubes. Over a period of about three months tissue forms around the spring-like device that prevents eggs traveling into the uterus and being fertilized thus precluding pregnancy.
It can be a very quick procedure – the kind of procedure that can be done in a doctor’s office on a woman’s lunch hour.
Unfortunately, not all women tolerate the device. Although the FDA still considers the Essure contraceptive device to be safe the FDA has received close to 15,000 reports of adverse events between November 2002, when the FDA first approved the device and the end of 2016.
“I will tell you,” says Kennerly, “The medical device industry has a poor track record and it has a phenomenally poor track record when it comes to women’s health in my opinion. I think they put less care into the world of women’s products than they do other products.”
In fact there have been complications related to a number of birth control devices including Norplant and the Dalkon Shield.
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The FDA reports that the device can sometimes fail and result in “unintended pregnancies”.
On November 18, 2016 the FDA released a benefits and risks information page for women who use Essure. The FDA is continuing to monitor the device.
Bayer has argued that since the FDA approved its Essure contraceptive device the company is not responsible for any complications women may experience. The company also says doctors who do not insert the device properly may be the cause of the issues women have reported.