This morning was a great morning. Fellow patient advocate, Joleen Chambers of FIDA (Failed Implant Device Alliance), and I met with Ms. Esperanza Worley, Deputy District Director for U.S. Congresswoman Eddie Bernice Johnson of Texas’ 30th District. We met with Ms. Worley for more than an hour, and we covered quite a bit of ground.
We asked that the Congresswoman, a former RN herself, take immediate action regarding the serious, life-altering and PREVENTABLE injuries affecting mesh-injured patients and patients of Bayer’s Essure device for permanent female sterilization.
We emphasized the FDA’s lax, highly-negligent oversight of the medical device industry in general, even calling for the resignation of, Jeffrey Shuren, Director, Center for Devices and Radiological Health since 2010, who has come under scrutiny regarding clear conflicts of interest, which render him unfit for such a position with the FDA. Read more from Joleen’s FIDA blog, here: Injured Device Patients Blitz CDRH’s Shuren.
Also of great concern, Shuren’s wife, Allison W. Shuren, is a partner at Washington-based law firm Arnold & Porter, LLP and is co-chair of the firm’s FDA/Healthcare Practice Group. As her bio states, she “advises a broad group of clients, including pharmaceutical, medical device, and biotechnology companies, physician practice management companies and physician practices, hospital and academic medical centers, ambulatory surgery centers, healthcare professional societies, diagnostic imaging centers, and Internet-based healthcare companies.”
One can easily conclude that the couple’s entire household income is dependent upon the success of a failing and harmful tax-payer-funded regulatory agency – maybe the most important regulatory agency responsible for the domestic safety and protection of the American people. Read the National Law Journal’s article in its entirety here: How Large are the Public-Policy Practices Within Law Firms?
We found in Ms. Worley a sympathetic ear, and as a woman herself, she took great interest in our shared causes. She was emphatic that she would share the information we provided her with EBJ and Washington TODAY! We spoke at length about the preventable harm that is befalling so many patients under a regime of stakeholders who stand to benefit from rushing devices to market and keeping them on the market.
- The FDA’s MedWatch Program for reporting adverse events: Passive and reactionary, MedWatch is a convoluted interface that’s difficult to navigate and not well-publicized to patients who would seek to report complications. MedWatch doesn’t serve those who have no internet access and/or are not technophiles, and thus, contributes to the under-reporting of serious adverse events.
- The mainstream media seemingly REFUSES to cover the widespread harm to hundreds of thousands of mesh-injured patients. I noted that my well-sourced, well-cited comments had been deleted three times from a recent online story in the Terre Haute Tribune Star (Illinois/Indiana) about the FDA’s Active 522 Study of Coloplast Restorelle vs. Native Tissue Repair for treating POP.
- Issues with Informed Consent: How is a patient enabled to provide true, informed consent when the medical device company, who stands to benefit from the patient’s consent, is responsible for educating that patient’s doctor and thus, the patient (conflict of interest, perhaps)? And how were doctors or patients to know of PERMANENT adverse events when vaginal polypropylene mesh was not studied long term before coming to market?
- The FDA’s antiquated and deeply-flawed 510(k) process for clearance of medical devices: The current legislation for regulation of medical devices was put into effect in 1976! The FDA’s website states, “The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.” What has legislation done to protect the millions of harmed patients since then? Clearly, it’s time to modernize this legislation, as the healthcare climate was SUBSTANTIALLY different in 1976 than it is now, almost 40 years later.
- The FDA’s 522 post-market surveillance program often churns out faulty science. A current 522 study seeks NEW participants to compare Coloplast Restorelle vs. Native Tissue Repair.
- This 3-year study cannot possibly accurately reflect outcomes and complications from the implant of a PERMANENT DEVICE.
- The study is recruiting patients as young as 18!
- The study seeks to “exclude” patients with “a known sensitivity to polypropylene.” How are doctors going to measure that? To my knowledge, there is no test for “sensitivity to polypropylene,” and if there is, WHY wasn’t this metric used BEFORE millions of people were implanted?
- Why is the FDA 522 study a prospective study, rather than a retrospective study? The latter would measure outcomes from a patient population already available, which seems a MUCH safer approach and the study could be longer than three years, giving more comprehensive and longitudinal data.
- I also asked for detailed, proactive follow-up on the letter EBJ sent to the FDA in 2013 regarding the dangers of polypropylene mesh implant.
I am ENCOURAGED today, for this is another step towards exposing the dangers of our country’s Healthcare System AND its primary regulatory agency, the FDA. Thank you Esperanza for giving voice to our community, and for opening your heart and mind to our pleas for help.