Posted on 3rd August, 2019
by Legal Staff
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 about the current actions of the FDA.
FDA Commissioner Scott Gottlieb and the director of the Center for Devices, Jeff Shuren made a recent statement on efforts to evaluate 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 make sure that companies are giving proof that risks to patient health have been sufficiently evaluated. The agency says that data from studies will instruct how to evaluate new devices submitted for review.
The FDA showed that studies on thousands of explanted devices revealed heavier wear between the metal parts of the implant than what was expected.
The tests performed on the implants before the FDA allowed them on the market did not reveal such a high level of wear. Manufacturers have agreed to pay a total of more than $1 billion to settle claims over MoM total hip replacement devices.
Interim results from postmarket studies show that patients with an implanted metal-on-metal total hip device have blood metal ion levels that are significantly higher than those without metal implants. According to Gottlieb and Shuren, although that's not unexpected, the accepted blood level threshold measurement (7.0 parts per billion mg/l or higher) for metal ions is not most favorable in determining if a metal-on-metal device is 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 for those that still had the implant.
Shuren and Gottlieb said that this suggests that, besides metal ion levels, there are additional factors that affect which patients experience adverse events from these devices.
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.
This statement was the latest in a series that the agency has issued following growing public criticism of its efforts to regulate the medical device industry. In the past year, the FDA has been particularly faulted for patient injuries attributed to faulty devices.
Have you experienced complications after a hip replacement procedure? Atraxia Law can help. We help individuals who have needed additional surgical procedures due to the failure of a hip implant find out if they qualify to bring a compensation claim.
Compensation may include coverage for medical costs and medical treatment, medication, damages for pain and suffering, past and future lost wages. Contact Atraxia Law today to see if you are eligible to seek compensation through a claim.