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https://www.petition2congress.com/ctas/the-medical-device-safety-act-hr-2164

The Medical Device Safety Act H.R. 2164

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The Medical Device Safety Act 2017 H.R. 2164 #MDSA17

The Medical Device Safety Act of 2017 was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.

We are asking for your support of The Medical Device Safety Act 2017, H.R.2164, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are tens of thousands of consumers who have been harmed by, disabled by, or lost a loved one to a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA17

Surgical Mesh: High-Risk Device via FDA

FDA NEWS RELEASE

FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” 

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

Beginning in Jan. 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health Notification.

Surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of this proposed order.

The FDA will take comments on the proposed order for 90 days.

For more information:

•               FDA Medical Devices

•               FDA: Proposed Order - “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation” 

•               FDA: Proposed Order - “Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”

•               FDA: Urogynecologic Surgical Mesh Implants

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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For Immediate Release: April 29, 2014  
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA, DICE@fda.hhs.gov

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