Have you undergone hip replacement surgery and suffered from severe pain or required corrective surgery?
Then it might be of interest for you to learn that in March 2019, the FDA Commissioner Scott Gottlieb and the Center for Devices, Jeff Shuren, made a statement on materials in medical devices.
Metal-on-metal (MoM) total hip replacement devices were among the products called out in the statement. The FDA also provided interim results from the "522" postmarket surveillance studies program for the devices.
MoM total hip replacement devices have been moved into a higher-risk category since 2016 and are no longer sold in the U.S. This action came after several years in which the implants have been followed relentlessly by safety concerns. Many patients still have devices implanted.
The FDA also decided to demand postmarket studies. With this requirement, the FDA wanted to ensure that companies are offering proof that risks to patient health have been sufficiently evaluated. The agency says that data from studies will evaluate new devices submitted for review.
It is estimated that over 500,000 American patients have received metal-on-metal (MoM) hip replacements. These devices are more prone to failure after a few years than those made of alternate materials.
MoM hip implants lead to the loss of tissue and bone inside the hip joint due to the release of tiny metal ion particles that cause inflammation.
As the ion particles find their way into the bloodstream, the implant can cause heavy metal blood poisoning. Four of the most problematic MoM hip implants are the Stryker Rejuvenation and ABGII hip stems, the Biomet joint replacement system, Zimmer Durom Acetabular Component, and the DePuy ASR hip replacements.
In 2008, amid complaints about a high failure rate, Zimmer suspended sales of the Durom acetabular cup in the U.S. The company subsequently faced product liability claims. Plaintiffs typically sought damages because defects in the Durom Cup caused complications and early device revision.
For example, a California jury awarded $7.68M to a plaintiff injured by a defective Zimmer MoM hip implant. As a result of the problems he experienced following an initial procedure, he underwent two hip replacement surgeries within 15 months.
One problem with this class of implants is that interactions between the metal ball and the metal cup can cause the release of ion particles that can enter the bloodstream.
According to the FDA, parts of the implants are also at risk of eroding. Those issues have had significant consequences for individuals who underwent hip replacement surgery. Johnson & Johnson settled for around $1 billion to resolve most of the claims related to its Pinnacle MoM hip implant.
The FDA showed that studies on thousands of explanted devices revealed heavier wear between the metal parts of the implant than what was expected. However, the tests performed on the implants before the FDA allowed them on the market did not reveal such a high level of wear.
Interim results from postmarket studies showed that patients with an implanted metal-on-metal total hip device had blood metal ion levels that were significantly higher than those without metal implants.
According to Gottlieb and Shuren, although that was not unexpected, the accepted blood level threshold measurement (7.0 parts per billion mg/l or higher) for metal ions was not most favorable in determining if a metal-on-metal device was functioning properly.
Certain patients had higher levels of metal ions in their blood and no adverse events, while severe symptoms were present in some patients with lower levels. According to the FDA, the levels of metal ions in the blood were higher for patients who had the device removed from their bodies than those who still had the implant.
Due to non-allergenic responses, skin patch testing or other current efforts to predict adverse events may be insufficient. The FDA representatives trust that the development of novel screening tests and further material science study may lead to patients not receiving devices that contain materials to which they are hypersensitive.
Have you experienced complications after a hip replacement procedure? Atraxia Law can help. We help individuals who need additional surgical procedures due to hip implant failure, so call us to determine if you qualify for a compensation claim.
Compensation may include medical costs and medical treatment, medication, damages for pain and suffering, past and future lost wages. Contact Atraxia Law today for a case evaluation.