Articles Posted in Medical Device Injuries

Medical products and devices are often used in surgical procedures and other medical treatments. In some cases, these devices can save lives. However, sometimes these devices can be dangerous and may result in more serious injuries than the injuries they are used to treat.

SurgeryPelvic mesh, sometimes called vaginal mesh or surgical mesh, is a medical device that is used in procedures to support repairing weakened or damaged tissue. The Food and Drug Administration (FDA) has warned of complications associated with surgical mesh when placed in the vagina.

In some cases, the mesh can erode and cause patients pain, infection, bleeding, and other issues. Pelvic mesh implants became common a decade ago to treat urinary incontinence, or involuntary leakage of urine. Many women experience a condition in which the bladder and other organs, weakened by childbirth, sag over time, causing incontinence. In recent years, thousands of lawsuits have been filed against Johnson & Johnson, the manufacturer of pelvic mesh, by women alleging they were harmed by the implants.

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In a recent case, a woman had surgery done at a hospital and subsequently suffered a stroke. The woman filed a products liability claim against the manufacturer of one of the medical devices in the surgery. However, when the complaint was originally filed, it did not name the hospital or the doctor as defendants. It also did not state a claim for medical malpractice. Several months later, the woman requested to file an amended complaint to add the defendants and allege medical malpractice. She then filed the amended complaint almost four months after the original complaint.

HourglassThe hospital and the doctor then moved for summary judgment, alleging that the filings were untimely. In the jurisdiction where the case arose, a medical malpractice action must be filed within two years of the cause of action accruing. The original complaint was filed just one day before the two-year statute of limitations had run. Thus, by the time the woman amended the complaint, the new claim against the defendants was not timely. The court granted the defendants’ motions because the claims were filed against them after the statute of limitations had expired. The state supreme court agreed, resulting in the dismissal of the claim.

Amending a Complaint and Its Effect on the Statute of Limitations

The statute of limitations is the time period during which a plaintiff can bring a certain kind of claim. The period of time varies depending on the type of claim and the jurisdiction, or the place in which it is filed. Often, the time begins to run from the date of the injury, the date that an injury was discovered, or the date that it should have been discovered.

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With advances in medical technology, many medical procedures that used to be daunting are now routine. Patients often arrive at a hospital or surgical center early in the morning and leave by mid-afternoon with few after-effects from the procedure or anesthesia. Many are able to even return to work the next day.

Grandpa shows off his pacemaker.

For doctors, medical procedures are an effective way of monitoring for certain conditions or diagnosing a new illness. Procedures are also lucrative medical treatments, and the more procedures a doctor squeezes in during a day, the more money the practice or hospital is reimbursed by insurance companies.

Companies that design and manufacture medical devices also stand to profit significantly from the widespread use of one of their devices. In some cases, the race to bring new products to the market results in great innovations, with patients benefiting from less invasive but equally effective procedures. In other cases, however, the drive for profits may cause a company to overlook faulty equipment and rush a product to market. Companies may also provide doctors with inadequate instructions on how to use or clean a device.

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A Tennessee-based medical device company has issued a recall for a prosthetic part used in hip joint replacement surgeries. According to one news source, the recall is a Class I recall. Class I recalls are issued when there is a reasonable probability that continued use of the device will cause serious health problems or even death.

orthopaedics-in-africa-1466621The part is one of three prosthetic parts used in a total hip replacement surgery. According to the U.S. Food and Drug Administration, the part has been fracturing more than anticipated after surgical implantation. If a fracture occurs, patients may suffer from an array of symptoms, including pain, instability, and trouble walking. Fractures may also require emergency surgery to replace and repair the broken part. This is called revision surgery, which is often more complex and risky than original hip replacement surgery.

As a result of the recall, the company has informed product distributors, hospital personnel, and surgeons to cease selling and using the recalled part. The company has also recommended that patients immediately contact their doctor if they experience sudden pain, instability, difficulty walking, tingling, or a loss of feeling in the surgical leg. For patients not experiencing any of these symptoms, the company does not recommend following up with a medical professional at this time.

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According to news reports, eight patients who underwent heart bypass surgery at a Pennsylvania hospital most likely suffered bacterial infections because of a contaminated medical device used during the surgeries. The device is a heater-cooler unit used to control a patient’s blood pressure during open-heart surgery. Of the eight patients who were likely infected by the device, four died.

heart-1-1566858After a joint investigation with the Federal Centers for Disease Control and Prevention, the hospital announced that the infections were probably the result of the contamination of tap water used in the device. According to the hospital, the devices were not being cleaned in full compliance with the manufacturer’s guidelines. To prevent further bacterial contamination, the manufacturer now recommends that the devices be filled with filtered water and hydrogen peroxide and cleaned with bleach.

Patients undergoing bypass surgeries are more susceptible to infection. According to the U.S. Food and Drug Administration, there have been 32 reports around the world of infection or contamination relating to the medical devices. Even so, the total number of infections resulting from the device is not exactly known, since symptoms do not always surface immediately after surgery.

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