Defective Medical Products Comments Off
A Ventura County mom says a permanent contraceptive device called Essure has caused her and thousands of other women excruciating pain. According to a news report on CBS Los Angeles, Tanya Lovis says she was walking around hunched over holding on to her stomach for three weeks out of the month and that “the pain was just too much to bear.” For 10 months, doctors could not figure out what was wrong with Lovis. When she started researching her condition online, Lovis says she found 1,800 women on Facebook who had also opted for Essure and were experiencing similar symptoms.
Woman Experience Severe Symptoms
Essure is a form of permanent contraception, which claims to be less invasive and more effective than the traditional method of having the Fallopian tubes tied. Under this procedure, a pair of coils is inserted into a woman’s Fallopian tubes prompting tissue to grow around the coils and seal the tubes. Essure does not require surgery. All Lovis was told after her procedure was that she would experience some cramping afterward and that she could even go back to work the next day.
Lovis, who recently had a pelvic exam, was told that she needed a full hysterectomy, where the uterus is removed. When the Essure coils were out of her body along with her uterus, Lovis’s painful symptoms disappeared. Consumer advocate Erin Brokovich has also said that she is looking into the issue because she has received an enormous number of emails about Essure. Bayer, which makes Essure, says 750,000 women worldwide have used this device. The U.S. Food and Drug Administration (FDA) approved Essure in 2002 and gave it what is known as “preemption” status, which means women who experience negative symptoms cannot sue the manufacturer.
Holding Medical Device Manufacturers Accountable
A campaign is on now to urge lawmakers to reevaluate this medical device’s preemption status. Given the fact that thousands of women have reported similar symptoms after being implanted with this medical device, it is only appropriate that the FDA conducts an investigation and removes the manufacturer’s preemption status.
Not doing so will violate the rights of these consumers who believed that they were receiving a safe product. Women like Lovis would have had to undergo unnecessary surgery to get relief from the excruciating pain. As a California products liability lawyer who represents victims of defective medical devices, I strongly urge the FDA to do the right thing and uphold consumer rights.