As DePuy hip recall attorneys, we have heard many disturbing reports which place the blame for the DePuy hip recall squarely at the doorstep of the United States .
FDA “Approves” Implants by Default
Although most hip implant patients assumed that their hip replacement manufacturer (e.g., DePuy, Zimmer, Johnson & Johnson, Stryker, etc.) received approval from the FDA for their device, this assumption is not entirely accurate.
For years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.
Ironically, although DePuy claimed its ASR XL Acetabular or Resurfacing implants were “substantially equivalent” to other hip implants, DePuy was not required to make its product out of the same metals as already existing marketed hip implants. As such, reports have shown that the FDA never considered the effects of the chromium and cobalt metals used in DePuy’s hip implants. As a result, consumer advocates have argued that the FDA allowed DePuy to use – without any FDA testing- potentially hazardous metals in a medical device without proper oversight.
DePuy Hip Recall Attorneys in New Jersey and Philadelphia
The DePuy hip recall shows the potential danger in this process. What is the lesson? All potential hip implant patients should specifically ask whether their hip implant device has received formal FDA approval or was approved through the FDA 510(k) loophole. As a New Jersey and Philadelphia DePuy hip recall lawyer, we strongly encourage and current recipients of a DePuy hip replacement to contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Let the team at the Mininno Law Office earn you the compensation you need and deserve.
Recently, the prestigious Washington Post reported on a fairly widespread yet rarely discussed practice of medical device sales representatives to lurk in operating rooms, without patient knowledge or approval, and guide surgeons in the surgical procedure. According to the Washington Post, this practice of sales rep “assistance” is common among medical device companies including Johnson & Johnson, Stryker, Zimmer, and DePuy.
Despite this responsibility, the FDA has not done much regarding the recall since July 17, 2010, the date they posted information on specific recalled devices. The recall contained DePuy
As New Jersey and Philadelphia DePuy hip recall lawyers, we are telling our clients that they should give their own orthopaedic surgeon the benefit of the doubt and listen to what the surgeon has to say about their options. Of course, we are also recommending that all patients get a second, independent medical opinion from another orthopaedic surgeon regarding the nature and extent of their current condition, whether or not they have
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, marketed its DePuy ASR XL Acetabular Hip Imlplant System and ASR Hip Resurfacing Systems worldwide, and all are included in the recall. In December of 2010, about 1,500 Canadian patients who had DePuy hip replacements filed a DePuy class action lawsuit in the courts in Quebec, Calgary, Alberta, Halifax, Nova Scotia, and Montreal. DePuy hip recall lawyers in Canada are helping these DePuy hip recall claimaints. It is likely that other DePuy hip implant patients in Europe will soon be filing similar class actions as a result of the DePuy hip recall.
As we have posted previously, all hip recall lawyers will explain that a partial or total hip implant is not a cure for hip pain. However, what makes this Depuy hip recall so unusual is the extraordinarily high failure rate as compared to DePuy’s hip implant competitors. In fact, the medical research which lead to the hip recall has shown that between 12 and 13 percent of Depuy hip implant patients will require a hip replacement revision surgery within five years of receiving the replacement.
In the United States, hip replacement surgery is one of the most common orthopaedic surgeries that occurs each year. In fact, since 1997, there have been approximately 300,000 hip replacement surgeries performed in the United States. Without question, the development of prosthetic hip joint replacements, and the development of cement or “glue” to securely place these implant parts into the human skeleton, has been one of the most major advancements in orthopaedic surgery during the last several decades.
Chromium and Cobalt. These metals are not found in your local vitamin store: Chromium is a chemical element found on the periodic table under atomic number 24. It is used to make stainless steel and all of the shiny parts called “chrome” on automobiles.
Similarly, Cobalt is also a chemical element found on the periodic table under atomic number 27. Since ancient times, it has been used as a blue pigment to tint glass, jewelry, and furniture.
What is known is that the recall affects the ASR XL Acetabular System, which is used for total hip replacements, as well as the ASR Hip Resurfacing System, which is used in a newer kind of procedure involving bone conservation.