I applaud Congressman Mike Fitzpatrick's efforts in drafting the E-Free Act to take the Essure permanent birth control device off the market. It is a very effective message to the FDA to do their job regarding such a potentially harmful product.
San Diego, CA (PRWEB) November 11, 2015
Martin Schmidt, of Schmidt National Law Group, issues a formal statement on Essure's newly drafted "E-Free Act." Schmidt commends Congressman Fitzpatrick on drafting the bill and prompting the FDA to take action for this potentially dangerous device.
“I applaud Republican Congressman Mike Fitzpatrick's efforts in drafting the E-Free Act to take the Essure permanent birth control device off the market. It is a very effective message to the FDA to do their job regarding such a potentially harmful product."
According to Mr. Schmidt, "I talk to women all day long who have had the same complaints regarding Essure. They all suffer debilitating abdominal and pelvic pain, heavy and irregular bleeding, symptoms of nickel poisoning and autoimmune reactions. Why isn't the FDA hearing those same complaints?”
While the E-Free Act may prompt the FDA to either take Essure off the market, or at a minimum require Bayer to issue appropriate warnings, “Congress cannot, in my opinion, force the FDA to take a specific course of action since the FDA is an independent agency.”
“The real problem is the language of the Medical Device Act which may pre-empt state law, and leave anyone who has been harmed by a medical device without any protection whatsoever."
As stated in NCBI in a 2008 publication, Congress passed the Medical Device Act in response to the Dalkon Shield intrauterine device which injured thousands of women. Congress' intention at the time was to provide protection. The unintended consequence actually did the exact opposite.
Mr. Schmidt firmly believes that, "Congress needs to amend the language of the Medical Device Act to allow the Courts to provide the scrutiny and the protection that the Medical Device Act should have provided in the first place."
About Schmidt National Law Group: In his 30 years as a trial attorney, Martin Schmidt has represented many victims of defective drugs as well as those injured by defective products and personal injury accidents. Schmidt National Law Group is a personal injury firm located in San Diego California, and its attorneys represent victims of all types of injuries.