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Arlington Heights defective medical device attorneyUPDATE: The recall discussed below, which took place in 2014, was for two lots of ParaGard devices that were not known to be fully sterile. The ParaGard IUD has never been subject to a full recall. However, in the years since this recall, many patients have reported issues with the devices, and multiple lawsuits are currently pending against the manufacturer.

The primary issue that has been reported with the ParaGard IUD is the possibility that it will break, usually when being removed from a patient's uterus. This can leave fragments of the device inside a person's body, and these fragments may need to be surgically removed to prevent further damage to the uterus or other organs. Since 2013, there have been more than 3,000 reports of device breakage made to the Food and Drug Administration (FDA). Nearly 2,000 of these events were considered serious, and 102 people have been hospitalized or faced life-threatening complications. It is likely that the issue is much more widespread, since there are many more people who have not reported incidents to the government or who are unaware of the risks they may face.

While the FDA has not indicated that it will be conducting investigations into the safety of ParaGard IUDs, some online communities are working together to help people share their experiences and raise awareness of the risks people face. In addition, at least 55 lawsuits have been filed in 20 different states by women who have suffered injuries because of the breakage of these devices. If you have experienced any injuries or health issues related to ParaGard IUDs or other birth control devices, Newland & Newland, LLP can advise you of your legal options and help you take action to recover financial compensation. Contact our Schaumburg personal injury lawyers today at 847-797-8000 to arrange a free consultation.

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Arlington Heights defective medical device attorneysMedical technology is constantly improving, and new devices and techniques are regularly made available to help address patients’ conditions and improve their health. Unfortunately, there are many cases where new products are found to be unsafe after being made available for public use, and defective medical devices can cause serious injuries to patients. Those who have been injured by these devices will want to work with a personal injury attorney who can help them determine their options for pursuing compensation from a product’s manufacturer or others who were responsible for their damages.

Medical Device Recalls and Patient Injuries

The U.S. Food and Drug Administration (FDA) regularly reviews and investigates the medical devices that are used by doctors and hospitals throughout the United States. If the FDA uncovers problems with medical devices that may present a danger to patients, a device’s manufacturer may be required to perform a recall, which may include removing devices from the market or performing repairs to address issues that affect patient safety. Some medical devices that have been subject to recalls in recent years include:

  • Hip replacements - Artificial hip joints may be made of metal and other materials, but those that have metal-on-metal components have a high failure rate. Corrosion and wearing of these components can release toxic substances into a patient’s body, leading to infections, damage to muscles, nerves, and bones, and other complications.
  • Transvaginal mesh - These implants have been used to address issues such as incontinence or injuries to pelvic organs. In some cases, mesh implants can deteriorate and break down, leading to sharp fragments that can perforate tissues and organs, resulting in internal bleeding and infections.
  • IVC blood filters - Small metal filters may be inserted into major blood vessels to prevent blood clots from traveling to the lungs, brain, or heart. These filters may break apart, and metal pieces may travel through the bloodstream and perforate organs, leading to hemorrhaging and organ damage.
  • Surgical warming blankets - During surgery, blankets that are heated by warm air may be used to stabilize a patient’s temperature. However, the circulation of air through these blankets may allow for the spread of germs, leading to serious infections.

Contact Our Rolling Meadows Product Liability Lawyers

While medical devices are meant to improve patients’ health, they can cause long-lasting or permanent injuries if they do not function properly. The attorneys of Newland & Newland, LLP can help you determine your options if you were injured by a defective medical device, and we will fight to ensure that you are fully compensated for the damages you have suffered. Contact our Palatine defective product attorneys at 847-797-8000 to set up a free consultation today.

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An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing. In particular, the group referenced a medical tool used in performing hysterectomies which, despite being widely available, has been found to contribute to the spread of cancer in patients.

This week, America's Health Insurance Plans, an organization representing nearly 1300 health insurers who provide coverage for over 200 million Americans, sent a letter to United States Senator Bob Casey, D-Pennsylvania, citing the dangers discovered regarding laparoscopic power morcellators. Since the 1990s, morcellators have been used to remove fibroids, or benign uterine growths, frequently during hysterectomies. Last year, the U.S. Food and Drug Administration (FDA) announced that women undergoing such procedures may be at higher risk for a certain type of malignant cancer, and use of the devices can potentially spread the cancerous tissue and worsen the condition.

While medical officials are reporting a significant drop in the use of power morcellators, they remain on the market. Johnson & Johnson, once the largest manufacturer of such devices, however, has withdrawn from the market.

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It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted. The main issue with the device is that it was found to be subject to a high rate of corrosion at the neck junction.

In November of last year, an agreement was reached in New Jersey that determined that the manufacturer would pay an average of $300,000 per implant in individual lawsuits brought against it. In some cases, depending if the patient is deceased, the payout may be less. In other cases, in which the pain and suffering is determined to be extreme, the payout may be more. The company, in total, would payout $1.4 billion in settlement claims, though the claim must be filed by an individual patient, even in this mass tort case.

If you have experienced pain or suffering because of a Stryker hip implant, the first step is to seek legal counsel. The next is to enroll in the Settlement Program. Enrollment opened on January 16 of this year, and is open until March 2. If you do not enroll in the Settlement Program before March 2, you will not be eligible to receive compensation. The fact that you enrolled in the claims process, however, does not guarantee that you will receive payment either. If you did not register for the settlement by December of last year, it is possible that you are not eligible to enroll. If this is the case for you, it is imperative that you speak with an attorney right away.

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A recent report shows the number of recalled medical devices continuing to increase. In response, many watchdog and consumer protection groups are aiming to make stricter requirements for medical devices.

A “cadre of insurers and other healthcare stakeholders” is urging the U.S. Food and Drug Administration (FDA) to “establish more registries to monitor and report performance” of medical devices being used in the U.S. market, according to MassDevice.com.

This cadre is requesting that the medtech registries be updated to enable more detailed information-gathering on devices that have been cleared or approved. Hence, this would help to ensure that complications resulting from the use or implementation of a faulty device would be recorded as soon as possible. This could help alleviate scenarios in which faulty medical devices are used, even after the first reports of failure.

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