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New Hope For Hip Implant Patients?
1 in 10 hip replacement surgeries fail, forcing the patient to undergo risky revision surgery. If the hip implant fails, it usually infects the bone. In the subsequent osteotomy, the doctor must remove both the defective implant and the infected bone. That bone loss makes the revision surgery a very low-percentage gamble, because there is not enough remaining healthy bone to anchor a second implant.
Some doctors say that a temporary spacer increases the success rate. The bone cement is laced with antibiotics, thus treating the infection without removing as much bone. Now, researchers in the United States and China have used a 3D printer to make a biometric sheath from hydroxyapatite and calcium phosphate and create a more custom fit.
In the near future, doctors hope to optimize the design, making the new spacer more like natural bone tissue.
Hip Implants
Following the lead of manufacturers like DePuy and Styker, many companies began making Metal on Metal (MoM) hip implants in the 1970s and 1980s. These devices were touted as more durable than Plastic on Metal (POM) implants, and thus more desirable for patients who were still physically active. A number of these implants have been recalled, and for good reason.
Stryker and DePuy Artificial Hip Device Recalls Lead to Litigation
Metal-on-metal hips were first marketed as providing a greater range of motion and longer lasting use for patients. However, due to poor design and performance of certain artificial hips, failure rates have rapidly increased. Medical device manufacturers Stryker and DuPuy both created and promoted products that did not undergo proper testing. As a result, many have suffered.
Reports have revealed that metal debris can slough off the artificial hip device, causing damage to surrounding tissue and entry into the bloodstream. A defective artificial hip can lead to serious conditions such as hip dislocation, disability, and permanent damage.
Two years ago, the FDA ended distribution of Stryker's Rejuvenate and ABG II artificial hip devices. Health concerns associated with these hip systems included:
- metal corrosion;
- damage to tissue, bones and organs;
Tylenol (Acetaminophen) Use and Liver Failure
Acetaminophen is one of the most common pain medications in the world. Johnson & Johnson manufactures the most well known brand of pain medication that contains acetaminophen, Tylenol. While many people consider Tylenol to be a very safe, over-the-counter drug, according to MedicinePlus, a publication of the National Institute of Health (NIH), acetaminophen overdose “is one of the most common poisonings worldwide.” It can be deadly if a person takes too large of a dose, according to NIH. Symptoms over acetaminophen overdose can include stomach pain, nausea, sweating, vomiting, appetite loss, coma or jaundice.
Taking too much Tylenol at one time is not the only danger of the drug, however. According to MedPageToday, a publication of the University of Pennsylvania School of Medicine, acetaminophen overdose or poisoning is without question the most common cause of acute liver failure in the U.S. People who are most at risk for acute liver failure as a result of acetaminophen poisoning include people who take drugs or drink alcohol, people who experience depression, and those who take many different medications that contain acetaminophen at the same time. In addition to Tylenol, according to the NIH, several cold or flu medications contain acetaminophen, as well as medications such as Percocet and Anacin.
Stryker Orthopaedics Faces Medical Product Liability Issues
Stryker Orthopaedics (“Stryker”) is one of the world's leading medical technology companies. Recently, Stryker has come under fire for some of its medical devices that have been found to be defective. In fact, over 2,000 plaintiffs have filed suit against Stryker because of faults in Stryker hip implants. A suit, entered on May 20, 2014, asserts that the Accolade TMZF femoral hip stem, designed and manufactured by Stryker, is a defective medical product with a premature failure rate.
The Stryker Hip Implant
The issues with Stryker hip implants have been going on for years. In 2003, the Trident Ceramic Acetabular System was introduced to the public, but soon came under attack following adverse event reports received by the FDA. This hip implant was in 2008.
Vaccinations: The History and the Dangers
The History of Vaccine Awareness
Vaccines are considered great defenses in helping prevent the spread of serious diseases. In 1986, the National Childhood Vaccine Injury Act was introduced. In addition to raising awareness of the potential vaccination dangers in children, the Act also created the National Vaccine Injury Compensation Program (VICP). The program, established in 1988, was to help ensure an adequate supply of vaccines, to guarantee that the costs of vaccines were stabilized, and to “establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines.”
The VICP program is an alternative to the traditional personal injury system of reporting faulty or dangerous vaccinations. The U.S. Court of Federal Claims determines who will be awarded VICP funds. Because of its status as a federal agency, of course, there is often quite a bit of red tape that a person must go through in order to be awarded these funds. Oftentimes, it can be easier to get the compensation you deserve if you work with a private defective medical device attorney.
When to Consider Hip Revision Surgery
If you have been implanted with a metal-on-metal hip implant, and you are suffering from pain or other problems, you are not alone. The FDA has received numerous reports about these devices, which lead to the creation of an entire website containing information on what to do if you have been hurt. In some cases, revision surgery may be required to correct the problems caused by the implant.
Depending on your condition, you may need to evaluate whether revision surgery can rectify a problem with your existing defective metal hip implant. If you already have a device fracture, loosening, dislocation, or infection, you should consult with your doctor as soon as possible. And if you find that you are developing local or systemic problems in relation to release of metal particles into your bloodstream, it is in your best interest to get medical attention sooner rather than later.
However, with that said, there are risks with revision surgery. One risk is having a reaction to the anesthesia or experiencing bleeding, infection, or blood clots. Speak with your doctor beforehand so that you are clear on the risks of participating in surgery. The surgery might be harder on you if the original implant affected your bone quality or soft tissue.
FDA Recommends Lower Dosage of Acetaminophen
Sometimes the most common drugs can be the most dangerous. In the second week of 2014, the Food and Drug Administration (FDA) issued a press release that recommended all “health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit.” Dosages of this amount or more have been found to contribute to liver damage, and when this dosage is coupled with other types of pain killing or serious drug treatments they are found to have serious side effects.
According to FDA Safety Information, “cases of severe liver injury with acetaminophen have occurred in patients who:
- took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
- took more than one acetaminophen-containing product at the same time; or
- drank alcohol while taking acetaminophen products.
The issue with overprescribing or over-taking acetaminophen isn't new. According to a New York Times review from 2011, an overdose of this common household drug is “one of the most common poisonings worldwide.” When taken in large doses, acetaminophen is deadly. In 2003, according to a different New York Times article, a group of 504 bottles of Dixon-brand acetaminophen were recalled because they had the incorrect dosage listed on the bottle. The FDA warned back then that overdoses can lead to “severe problems like liver toxicity and failure,” the Times reported.
FDA Issues HBOT Warning
The U.S. Food and Drug Administration (FDA) has issued a warning to consumers about hyperbaric oxygen therapy (HBOT) and how some companies may be using deceptive advertising to promote HBOT.
With HBOT, a person breathes pure oxygen in a pressurized chamber or room. The air pressure in the room is increased up to triple the amounts higher than normal, allowing the lungs to take in almost three times the amount of oxygen they would be able to take in under normal pressure. The oxygen flows in the blood throughout the body, which helps healing.
Some of the treatments the FDA has approved are decompression sickness (one of the dangers associated with scuba diving), bubbles in blood vessels, infections, and hard to heal wounds (a common side-effect of diabetes and radiation treatments), carbon monoxide poisoning and embolism treatments.
The FDA's issued their warning because they say there are internet sites that claim HBOT is a safe and effective treatment for a myriad of diseases and conditions that have not been approved by the agency. The agency is concerned that consumers who believe that these devises have been approved for other, unapproved conditions could be putting themselves at risk. Nayan Patel, a biomedical engineer in FDA's Anesthesiology Devices Branch, said, “Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies. In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).”
Johnson & Johnson Poised To Consider Settlement
The world's largest provider of products in the health care field is considering the benefits of settling a huge case regarding hip implant recalls. There are approximately 11,500 lawsuits pending around the country with regard to the defective medical devices, with numerous plaintiffs alleging serious medical conditions and side effects after their hip implants were installed.
The product manufacturer is considering settling all of the lawsuits with an offer of more than $300,000 per case. If it moves forward, this settlement would exceed $3 billion if the plaintiffs were to approve the terms. Previous discussions have yielded settlement offers of less than half this current amount.
In 2001, a manufacturer of a similar product, Sulzer, settled their cases for $1 billion. There are currently seven product-liability trials regarding J&J being held between September and January, which could certainly influence any settlement offers. The negotiations happening during this time are kept private.
Are Hip Implants Safe?
When it comes to medical devices that have been in the news, defective hip implants have been a constant player. Lawsuits surrounding hip implants have pointed out numerous weaknesses in the devices geared to help people, including complications requiring additional surgeries and even metal poisoning from implants that have broken down and released dangerous substances into the body.
A new lawsuit surged forth in July against Stryker, a company making hip implants that have been used across the country. This lawsuit was filed in Michigan by plaintiff Giniva Luque. The plaintiff alleges that she has had two different hip replacement surgeries, both involving Stryker hip replacement devices. Her hip implant surgeries happened in March, 2011, and September, 2012.
The patient, like many others who have raised concerns about the safety of hip implant devices, says that she experienced serious pain and discomfort in her body surrounding the area where the implants were added. Luque says she will have to schedule revision surgery for both hips to remove the faulty implants and put operable ones in instead.
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