Some Democratic congressmen are pushing for an investigation of <"https://www.yourlawyer.com/topics/overview/defective-hip-implants-Johnson-and-Johnson-DePuy-Hip-Implant">metal-on-metal hip implants. Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.), Diana DeGette (D-Colo.) and John Dingell (D-Mich.), all members of the House Energy & Commerce Committee, have written three top Republicans on the Committee seeking hearings on the regulation of certain medical devices, including all-metal hip implants.
Metal-on-metal hip implants include <"https://www.yourlawyer.com/topics/overview/DePuy-Hip-Implant-Recall-Johnson-and-Johnson">DePuy Orthopaedic’s ASR hip implant, which was recalled in August 2010 because of a higher-than-expected early failure rate. Other all-metal hip replacements that have been the subject of complaints and lawsuits include the all-metal version of DePuy’s Pinnacle hip implant system.
As we’ve reported previously, it is believed that metal-on-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems. Since January 2011, the U.S. Food & Drug Administration (FDA) has received more than 5,000 complaints concerning artificial metal-on-metal hip implant devices. In May, the agency directed 21 makers of all-metal hip implants, including DePuy, Zimmer, Stryker, Biomet and <"https://www.yourlawyer.com/topics/overview/wright-medical-profemur-hip-replacement-lawsuits">Wright Medical, to conduct post-market studies of their devices to determine if they were shedding dangerous amounts of metallic debris in patients.
In a letter dated October 12, Waxman, Pallone, DeGette and Dingell ask Energy and Commerce Committee Chairmen Fred Upton (R-MI), as well as Joseph R. Pitts (R-PA), and Cliff Stearns (R-PA), to hold hearings on the regulation and safety issues surrounding metal hip implants and brain stents. “The Committee’s hearings to date have focused on claims about FDA overregulation and consequent harms to industry,” a statement detailing the letter says. “. . . metal-on-metal hip implants are recent examples of devices that merit further investigation to determine whether there are harms associated with underregulation.”
“The metal-on-metal hip implant systems have ‘unique risks in addition to the general risks of all hip implant systems,’ according to the FDA. Because the metal rubs against the metal, ‘tiny metal particles may wear off of the device and enter into the space around the implant… [or] even get into the bloodstream.’ For some patients, these metal particles can cause damage to the bone or tissue surrounding the implant and joint, requiring a surgery to replace the implant. In addition to the local reactions, ‘high levels of metal ions in the bloodstream may cause symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland,'” the letter states.
The Democratic representatives also voice concern that the medical device hearings convened by the Committee thus far “have not provided a balanced and accurate picture that fully reflects the role FDA plays in reviewing device applications; nor have they spoken to the potential dangers posed to patients if medical devices are not appropriately regulated.”
