FORT WORTH — Tina Wilson has known since August that the Mirena brand intrauterine birth control device she got wasn't made in America.
She found out after seeing her gynecologist for severe abdominal pain and bleeding she believes is connected to that IUD.
"I was still having the same problems, and that's when Dr. Allen told me that I had received one of these Mirenas that the packaging was not in English," Wilson recalled. "That it was fine, safe... but the package was not in English. She said it was a shipping error."
According to a lawsuit filed by the Texas Attorney General in Tarrant County on Thursday, Women's Integrated Healthcare in Grapevine knowingly purchased nearly 500 IUDs from an online Canadian pharmacy. Those devices are $500 cheaper than the FDA-approved version.
Six physicians are now being sued for violating the Deceptive Trades Act and the State Health and Safety Code.
"I feel lied to," Wilson said. "I feel deceived."
In an interview with News 8, Dr. Angela Cope, who heads the practice, stands by their decision to insert a product they still believe is safe — despite warnings of counterfeits by the FDA and the manufacturer, Bayer Pharmaceuticals.
"There is not any medical difference in a Mirena imported from Canada versus a Mirena that's imported from America," Dr. Cope said.
But now, many women want to know how they can be sure their Mirena IUD is the FDA-approved version.
By law, physicians must keep a copy of the product's label and manufacturing number in case of recalls. All FDA-approved Mirena IUD packages are printed in English. Mirena IUDs considered illegal usually have boxes printed in a foreign language.
Patients have a right to see their medical charts, along with documentation from the IUD packaging.
By phone, the practice manager at Women's Integrated Healthcare offered no apology to Tina Wilson.
Wilson is left to wonder if the pain she is in is from an illegal birth control device she didn't consent to. She now plans to have it removed by another physician.
E-mail jstjames@wfaa.com
