FOX23 Investigates: Faulty medical devices causing health concerns

BARTLESVILLE, Oka. — Quick Facts:

Bartlesville man is among thousands of patients pursuing a lawsuit against DePuy over hip implants.

The man says the metal-on-metal device caused metal poisoning -- leading to other health concerns that affected his hearing and vision.

The attorney who won three monetary verdicts in these cases shared some of the evidence with FOX23's Shae Rozzi.

Evidence used in successful trials so far indicates the device maker knew there would be concerns years before recalling one device and deciding not to continue selling another

RECALL: See if your medical device has been recalled

WATCH FOX23 Anchor Shae Rozzi's full report: 

A video from a sales conference shows a company-paid doctor promoting the product as the "Billion Dollar Baby" while encouraging sales representatives to double their sales.

One of the concerns this attorney has is the 510(k) FDA approval process for medical devices which allows device-makers to get approval based on another approved product without testing the new product in any patients before it is sold.

There is a petition to get the "Medical Device Safety Act" passed in an attempt to better protect future patients. Patients will be in Washington later this month pushing for the passing of the Medical Device Safety Act

CHECK HERE to see if and how much your doctor has been paid by drug and medical device companies:

DePuy is part of the Johnson & Johnson Family of Companies and released the following statement:

"To follow up on your inquiry, total hip replacement surgery has been called one of the most successful and life-enhancing surgeries. Hip replacement devices have been available in the U.S. for more than 50 years, and have a long clinical track record of helping relieve pain and restore mobility for patients. Artificial hips, just like natural hips, are not perfect, and every surgery and implanted medical device poses potential risks and complications.

In developing metal-on-metal implants in the 1990s, DePuy and other manufacturers were responding to the medical need at the time for a hip replacement option that might better meet the demands placed by younger, more active patients and that would help reduce the complications with the implants previously available, including the wearing out of the polyethylene material that was widely used in hip replacement at that time.

DePuy's metal-on-metal hip systems, the ULTAMET® Metal-Metal Articulation and the ASR Hip Systems, have different designs and different clinical results. ULTAMET® Metal-on-Metal Articulation was used as part of a two-piece cup system and was discontinued in 2013 based on low demand for the product, the availability of alternative options that meet the clinical needs of patients and a proposed change in FDA regulation of all metal-on-metal total hip replacement products. ULTAMET Metal-on-Metal is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain.

The ASR Hip System, sold from 2005-2010, is a one-piece metal-on-metal only cup system that was voluntarily recalled by DePuy in August 2010 after information from the National Joint Registry for England and Wales showed a five-year revision rate that was not in line with data previously reported in that registry. Prior to August 2010, the totality of the data available to the company showed ASR was performing consistent with the class of large diameter monoblock metal-on-metal hip implants. We understand that the August 2010 ASR Hip System recall has been concerning for patients, their family members and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need.

DePuy monitors the performance of all of our products from a variety of sources, including joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports. If DePuy finds that a product is not meeting its high standards and the needs of patients we take appropriate action. Meeting the needs of patients is at the center of what we do, and everyone at DePuy is united by the common goal of improving patients' lives."  - Mindy Tinsley, Spokeswoman DePuy

The FDA released the following statement:

510k Modernization and Regulation

We believe firmly in the merits of the 510(k) process. Thousands of devices are cleared through this process each year and countless thousands more patients benefit from these technologies. But, the FDA is committed to ensuring that the 510(k) program is keeping pace with the important innovations we're seeing in device development. We're doing this through several efforts, including issuing new guidances and soliciting public feedback on ideas. For example, we recently issued draft guidance on the Safety and Performance Based Pathway, which we hope will modernize our approach to moderate risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices.

We're also considering whether the FDA should post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. Doing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements.

The FDA's device program is risk-based, which means devices that pose the highest risks to patients have the most rigorous requirements before they can be marketed. This system was set up by Congress to ensure patients are as best protected as possible from risks, while also enabling timely access to safe and effective medical devices, consistent with the FDA's mission to both protect and promote public health.

Generally, new technology is subject to a pre-market approval application (PMA) when it is high risk and subject to the De Novo pathway when it is lower risk. The 510(k) pathway is typically available for lower risk devices for which one or more similar technologies are already on the market.

The FDA may require extensive testing for devices subject to a 510(k), generally requiring more evidence for more complex technologies. Because most devices, unlike drugs, are hardware and have localized effects on the body, robust non-clinical testing can demonstrate that a device performs similarly to comparable devices already on the market and that its benefits outweigh its risks. And we can often get this information without subjecting patients to clinical trials. For example, for some devices, such as syringes and infusion sets, bench testing—for biocompatibility, and mechanical and physical performance tests—can provide the information the FDA needs to determine that these devices are safe and effective for patients. For others, such as some bone void fillers or substitutes, animal studies provide information in cases where histology and destructive testing cannot be done on humans. And, when appropriate, we do require clinical studies for certain devices subject to a 510(k).  

PMA is the most rigorous type of device marketing application required by the FDA, and is appropriate for higher risk devices where general and special controls are not sufficient to provide reasonable assurance of safety and effectiveness of the device. However, the PMA pathway is not appropriate for all medical devices. Requiring a PMA for lower risk devices that are similar to other devices already on the market—those eligible for a 510(k)—would not necessarily provide better patient safeguards, but would result in unnecessary costs and delays while diverting FDA staff resources away from studying and evaluating higher-risk and novel devices.

In a recent 2018 report, we discuss in detail efforts we've taken to strengthen the 510(k) program, including eliminating the use of 1,758 devices as predicates, how 30% of 510(k) submissions are not accepted for initial review, a 150% increase in the number of pages for each 510(k) since 2009, that FDA's staff spend more time reviewing each 510(k) submission than ever before yet continue to meet required performance timelines, and the publishing of more than 50 final and cross-cutting guidances and device-specific guidance documents to help improve predictability, consistency, and transparency of submission content while clarifying expectations, policies, and procedures surrounding review of 510(k) submissions.

Adverse Event Reporting and Postmarket Surveillance

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

When a device raises safety concerns, we will take steps to have those concerns satisfactorily addressed or have the device removed from the market. Voluntary recalls are used in the vast majority of these cases and almost always result in a faster action to remove or correct devices than the mandatory recall process. The FDA's experience is overwhelmingly that companies will voluntarily correct the problems—either on their own or at the FDA's request—to ensure that their proposed device can be placed on the market or their predicate device can remain on the market.

A 2018 FDA report on our enforcement activities outlines some highlights of recalls and other enforcement efforts including, a 50% increase in the annual number of voluntary recalls reported since 2009. The infusion pump case study in that report is a good example of how the FDAs enforcement activity led to an initial 3-fold increase in voluntary recalls from affected firms, a 56% reduction in annual recalls related to these devices since 2014, and an 82% reduction in annual medical device reports since 2015.

MDRs submitted to the FDA are only one source we use to monitor marketed medical devices. These reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence. Additionally, we may receive multiple reports related to the same event making it difficult to determine actual numbers of events.

When appropriate, the FDA employs a targeted, risk-based approach to address specific device areas of concern. The FDA monitors medical device malfunctions, industry compliance trends, and public health concerns. When the FDA identifies device quality or manufacturer compliance concerns, we inspect firms, take enforcement actions as needed, collaborate with stakeholders to address contributing scientific and policy challenges, and publicly communicate to ensure transparency and reduce the chance of similar, recurrent issues.

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