FDA Warns ThatMetal-On-Metal Hip Implants Can Be Dangerous. Hip implant surgery comes with tremendous risks that must not be taken lightly. Not only is the procedure dangerous and potentially life-threatening, but the design of some of the more popular brands from Johnson & Johnson, Stryker, and others have also failed to live up to the expectations the manufacturers placed upon their products. These products have made people suffer pain and anguish by causing the patients to undergo repeated surgeries and recovery. The U.S. Food and Drug Administration (FDA) has made it clear: hip replacement surgery and the metal-on-metal artificial joints used to relieve the patient’s suffering are dangerous.
Parker Waichman LLP is a national law firm whose attorneys are dedicated to delivering justice to their clients who have suffered at the hands of greedy medical device companies like Johnson & Johnson. Parker Waichman’s hip replacement attorneys relentlessly and aggressively pursue justice for their clients by forcing the offenders to pay substantial sums of financial compensation to their clients. Parker Waichman’s lawyers know no other wayto serve their clients’ best interests best.
Hip Implant Devices
The FDA approved five devices for hip replacement and implant surgery. The FDA approved devices range in composition from metal-on-polyethylene (plastic), ceramic-on-polyethylene, ceramic-on-ceramic, metal-on-ceramic, to metal-on-metal. An orthopedic surgeon is in the best position to determine what device is best suited to meet their patient’s needs as well as the type of surgery the patient requires because not all hip replacement surgeries and implants are alike.
The patient has two alternative surgical procedures for replacement surgery. A hip is a ball-and-socket joint. The head of a person’s femur is a ball that sits in the socket of the hip. Total hip replacement surgery involves removing the ball joint from the femur bone and replace it with the artificial device. Additionally, the surgeon fits a prosthetic cup into the socket and re-attaches the legsby inserting the new ball joint.
The other option is a partial hip replacement which is described by orthopedic surgeons as resurfacing. With resurfacing surgery, the physician smooths the head of the femur and places a cap upon it. The surgeon removes damaged bone and cartilage from the hip socket and linesit with sheeting.
Physicians must consider several factors when determining when discussing the procedure with their patient. The options the patient has for thetype of replacement, and the composition of the particular device depend upon the person’s lifestyle, their age, height, weight, and existing damage to the bony structures of their hip.
It is essential for physicians to consult their patients and advise them on the artificial hip that is appropriate for the patient. The patient has the ultimate decision but will most likely defer to the physician’s expertise. The physician obtains his or her information from FDA recommendations, experience, and sales pitches from the medical device manufacturers.
Risks Inherent in Surgery
Most medical procedures have some risk of death or severe illness that accompanies the procedure. Very few things in life are certain. Despite the number of hip replacement transplants doctors perform annually, and hip replacement surgery does not directly involve any vital organ in the body, surgery is traumatic on the body. Some of the risks inherent in hip replacement surgery are:
- An adverse reaction to anesthesia,
- Heart attack,
- Uncontrolled breeding,
- Bacterial or viral infections, and
- Blood clots.
Successful surgery is half of the total hip replacement procedure. A patient can suffer many adverse side effects from hip replacement surgery after the hospital discharges him or her. The continuing problems patients face are:
- Dislocation of the new hip,
- Broken bones,
- Infection in the joint,
- Nerve damage at or near the transplant site,
- The artificial hip loosening in the joint and moving around,
- One leg longer than the other, and
- Loss of bone.
All of these potential side effects can take a toll on a person’s life. Typically, people go through this surgery so that their lives improve. The last thing they want is their lives coming apart because of a medical device manufacturer like DePuy or Stryker manufacturing and designing faulty hip replacement components.
Danger of Metal-on-Metal Artificial Hip Components
DePuyOrthopaedics, Inc., a subsidiary of Johnson & Johnson, manufactured two metal-on-metal hip implant devices which have cost them billions of dollars in settlements and jury verdicts. DePuy settled litigation over their A.S.R. hip replacement device with for approximately $2 billion. Their other device, the Pinnacle Ultamet, is currently the subject of substantial litigation. Juries have awarded injured plaintiffs almost $3 billion in jury verdicts over the last two years.
These case involved patients falling ill, suffering additional injuries, and requiring further hip replacement surgery, called revision, to repair the faulty metal-on-metal devices. The FDA warns that metal-on-metal devices cause pieces of the implant to enter the bloodstream, nerves, and soft tissue surrounding the joint. The metals are cobalt and chromium and can cause serious side effects. Neither DePuy nor Johnson & Johnson warned about the potential problems with these devices.
Metal-on-Metal creates anunavoidable metal loss from friction in the joint. Physicians can take numerous precautions to lessen the quantity of metal entering the patient’s bloodstream. TO make matters worse, it is impossible to predict who will have an adverse reaction to the metal particles invading the bloodstream. Some patients suffer what doctors describe as “adverse soft-tissue reaction (ATLR).” A person is suffering from ATLR experiences difficulties with the implant. The muscles surrounding the implant, which are supposed to keep it in place, weaken and the artificial joint loosens or slips when a transplant patient contract ATLR. The patient can experience severe pain and could lose the ability to walk if the patient does not undergo revision surgery.
Typically implants last for fifteen years. DePuy’s A.S.R. and Pinnacle Ultamet lasted about five years before the patient required another invasion, painful, and dangerous surgery to remove the defective device and replace it with a new one. As discussed, revision surgery is risky, and the patient must endure blood loss, pain, lengthy rehabilitation, missed work, and diminishing quality of life.
Signs and Symptoms
The FDA has assembled a lengthy list of signs and symptoms of which a hip transplant patient with a metal-on-metal device must be aware. At the outset, the FDA recommends that people with no symptoms see their physician for testing regularly. However, a patient should see their orthopedic surgeon immediately if they experience any one of the following conditions:
- Loss of kidney function,
- Depression or mood swings,
- Problems hearing or vision,
- Skin rashes,
- Thyroid problems indicated by weight gain, lump in neck, fatigue, or feeling cold, and
- Heart disease.
Metal-on-Metal is not the only type of device that has caused substantial side effects. The FDA issued a recall on theproduct in 2017 because of problems with the femoral head component of the device. Stryker distributed over 40,000 of these defective items. They are ceramic-on-ceramic implants and have shown signs of wear before they should.
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