Will the FDA issue guidelines in the treatment and monitoring of patients with this device?
Many Physicians and patients that our firm have spoken to consistently talk about the lack of guidelines and attention given by the FDA to the health problems and risk utility of the Metal-on-Metal (MoM) hip replacement. Hopefully the FDA advisory panel that meets this week will result in responsible and informed decisions that will aide in the monitoring and treatment of the affected patient. The Panel is expected to ask questions of industry and consumer experts to determine in large part the implications of nearly a half million people that have recalled and non-recalled metal-on-metal hip prosthetics. The executive Summary of the Metal-on-Metal Hip Implant safety meeting can be found here.
A significant amount of time of the two day hearing (70 minutes) is dedicated to discussing protocols for the asymptomatic patient (a patient without symptoms) that may be subject to health problems from the device. Childers, Schlueter & Smith, LLC has learned first hand that physicians treating patients with both recalled and non-recalled hip implants do not have a set standard protocol for testing and monitoring patients in relation to the known health hazards that are being observed in many patients. Watch the portion of the hearings that are public on Wednesday and Thursday to determine for yourself and weigh the credibility of some of the industry experts that answer to the health problems and early failures of the metal-on-metal hip implants. The meeting will be webcast live and free of charge on both days for those interested.
A draft of 9 questions to be posed by the Panel have been posted on the FDA website:
Of notable significance is the outline and comments on the recommendations of treatment of the asymptomatic patient. Will the FDA say something definitive on this subject concerning:
a. The frequency of follow-up with the orthopaedic and/or primary care physician;
b. Which assessments should be included in the follow-up and whether the evaluations/tests should be done in any particular order and/or whether the decision to perform any is dependent on the results of other tests:
i. Physical and/or functional examinations
ii. Imaging assessments
iii. Metal ion levels (including the source, e.g., serum, whole blood, urine)
iv. Other laboratory tests
v. Other assessments to evaluate for subclinical systemic manifestations
c. Whether any finding, result, range of results or trend in results over time for the tests above should prompt an action or intervention including the need for more frequent monitoring or consideration for revision with particular emphasis on metal ion testing for Cobalt and/or Chromium.
d. Whether any particular patient or implant characteristic(s) – or combination thereof – would warrant follow up (e.g., more frequent follow-up, additional tests) and why.
· Weight, BMI
· Patient Age
· Underlying disease or indication for initial implantation
· Patient activity level/type
– Implant Age
· Femoral head size
· Acetabular cup position (inclination, anteversion)
· Acetabular cup thickness and coverage
· Diametrical clearance of components
· Taper length
· Unilateral vs bilateral implants
e. Would any of the recommendations made above change if the patient’s MoM hip is not a recalled hip such as the Depuy ASR or other known Metal hip that is under scrutiny for increased incident reports of failure?
There are now only five manufacturers that currently legally market MoM THR systems in the US:
- Biomet, Inc.
- DePuy Orthopaedics, Inc.
- Encore Medical, L.P.
- Wright Medical Technology, Inc.
- Zimmer, Inc.
What will be the ultimate outcome of these hearings? Our firm will be watching closely and continue to seek justice and accountability for the victims of faulty and defective metal-on-metal hip implants. One thing for sure is the tainted legacy of the metal-on-metal implant is sure to continue with so many consumers affected.
Feel free to share your insights and thoughts here on the topic in the comments section below.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer again in 2019, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys and a Top 100 Lawyer in Georgia by the National Trial Lawyers in 2019.