This week “Need to Know” medical correspondent Dr. Emily Senay examines whether the Food and Drug Administration’s medical device review process is adequately protecting the public. While the vast majority of these devices are safe and effective, according to the GAO, hundreds are recalled every year. And the impact of an unsafe device can be devastating.
In 2006, Linda Gross underwent a “minimally invasive” surgical procedure to implant mesh called PROLIFT® into her pelvic area — a device manufactured by ETHICON, a subsidiary of Johnson & Johnson. The mesh — which has since been pulled off the market by the manufacturer — was implanted to treat Linda’s original diagnosis of pelvic organ prolapse, a condition impacting hundreds of thousands of women. Following the procedure, Linda suffered complications when her body rejected the mesh.
Below you’ll find statements about the device from ETHICON and the FDA, the original brochure for the device and links to reports on the FDA process from the Government Accounting Office, the Institute of Medicine of the National Academies and the FDA.
Statement from the FDA to Need to Know:
Medical devices in the U.S. have a strong track record of safety and effectiveness. Specifically, the 510(k) program has helped bring lower-risk medical devices to patients who need them.
The FDA evaluates thousands of medical devices used by Americans each year and while the majority of these medical devices perform well and improve patient health, medical devices carry a certain level of risk, some higher than others, depending on the device. It is FDA’s job to determine that risk and weigh with the device’s potential benefit to patients.
After FDA approval or clearance of a medical device, we receive and analyze information about how devices are working outside of clinical trials, in real-world settings. We are constantly looking for better and faster ways to identify problems. Through our existing surveillance program, we work with manufacturers to correct device problems and communicate urgent information to health care providers and patients so that they can make informed health care choices. Moving forward, we are continuing to identify ways to more quickly identify poorly performing devices and share information about real-world device performance with health care providers and patients, which includes the clinical benefits and risks of devices.
The agency is committed to assuring that we review medical devices according to their appropriate level of risk, and carefully weigh that risk with the potential benefit for patients.
Statement from ETHICON to Need to Know:
“Ethicon’s primary concerns are patient safety, providing healthcare products to meet medical needs, and improving quality of life for patients in a safe and effective manner.
The PROLIFT procedure was developed by doctors seeking an improved pelvic floor repair surgery. Compared to other surgical options, the PROLIFT procedure was less invasive, reduced the number of days patients spent in the hospital and decreased the overall recovery period. Prior to the availability of pelvic mesh products, other surgical options, including procedures using native tissues, had unacceptably high rates of recurrence.
Both before and after the launch of PROLIFT, Ethicon consistently evaluated its products in clinical settings. Ethicon’s devices are among the most studied products for these conditions. PROLIFT was found to be efficacious and have a low rate of post-operative complications when used with appropriate patient selection and proper surgical technique.
As we have stated previously, while we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications. Furthermore, the risks unique to mesh were identified in Ethicon’s IFUs and in professional education and training materials, and were widely known and discussed in scientific literature. For patients, the PROLIFT patient brochure, which was designed to provide product information in order to prompt appropriate and informed discussions between patients and their doctors, also lists a number of potential adverse reactions associated with the use of surgically implantable mesh.
PROLIFT has never been a determining factor in Ethicon’s profitability, never constituting more than a very small percentage of Ethicon’s sales. Profits were not put ahead of patient safety.
Ethicon made a business decision to discontinue certain pelvic mesh products, including PROLIFT, that was based on several factors, including the devices’ commercial viability in light of changing market dynamics and the complexities of the regulatory environments in which we operate. This decision was unrelated to the safety or efficacy of the products or the mesh materials.”
Statement by Sheri Woodruff, Vice President, Communications ETHICON Surgical Care on the verdict in Linda Gross v. Ethicon, February 25, 2013:
“The punitive damage award is unsupported by the evidence presented at trial and we will vigorously pursue an appeal. The company will also appeal Monday’s mixed jury verdict and compensatory damages.
The jury found:
- the product involved in this case was not defectively designed and no misrepresentation was made to the surgeon;
- the company’s warnings to the surgeon were inadequate and that a misrepresentation was made to the plaintiff.
Ethicon acted appropriately and responsibly in the research, development and marketing of the PROLIFT pelvic organ prolapse repair kit. While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications. For more than a decade, Ethicon has invested in the research, development and clinical study of products to treat a wide range of pelvic disorders. Ethicon’s devices are among the most studied products for these conditions.”
FDA’s Premarket Review and Postmarket Safety Efforts, US Government Accountability Office, April 13, 2011.
FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process, US Government Accountability Office, January 15, 2009.
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Institutes of Medicine of the National Academies, July 29, 2011.
Understanding Barriers to Medical Device Quality, FDA, October 31, 2011.