Heart Attacks Caused by GranuFlo® and NaturaLyte® Dialysis Products

Hemodialysis is used to treat patients with acute or chronic renal failure. Hemodialysis treatments filter the blood, replacing the function of your kidneys. GranuFlo® and NaturaLyte® acid concentrate are products used in hemodialysis treatments. They have been recalled because they can cause heart attack and sudden cardiac death, as well as other serious health problems. If you believe that GranuFlo® or NaturaLyte® caused your injuries or the death of a loved one, please talk to our Georgia drug recall attorneys right away.

Improper Dosing

There is a high potential for improper dosing when using GranuFlo® and NaturaLyte®. They contain ingredients which create a higher level of bicarbonate in patients’ blood than similar products. Elevated bicarbonate levels can cause metabolic alkalosis. Health problems caused by metabolic alkalosis can include:

  • Low blood pressure
  • Hypokalemia (low potassium in the blood)
  • Hypoxemia (too little oxygen in the blood)
  • Hypercapnia (too much carbon dioxide in the blood)
  • Cardiac arrhythmia

Metabolic alkalosis can ultimately lead to cardiopulmonary arrest and death.

What You Can Do

If you have suffered a heart attack or heart problems as a hemodialysis patient, or if you have lost a loved one to what you believe may be GranuFlo® or NaturaLyte® injury, you may be entitled to compensation through a personal injury or wrongful death lawsuit.

Fresenius Medical Care was aware of the dangers and even warned its own clinics in an internal memo, months before alerting other clinics that used its products.

If you are a Georgia resident who has suffered a GranuFlo® or NaturaLyte® injury, or lost a loved one to these deadly dialysis products, please contact our Georgia drug recall attorneys at 1-877-LOSS-RECOVER (567-7732) right away. You may be entitled to monetary compensation, but you have limited time to act.

J&J to Halt Sales of Four Vaginal Mesh Products

Johnson and Johnson’s Ethicon unit says it plans to stop selling four of its vaginal mesh products. The company, along with other vaginal mesh makers, is facing hundreds of product liability lawsuits for serious injuries caused by the defective mesh. In July, 2011, the U.S. Food and Drug Administration (FDA) announced that serious complications associated with transvaginal mesh are not rare, and in January, 2012, it ordered J&J and 30 vaginal mesh makers to study the injuries and complications that have been linked to the devices.

If you have been harmed by vaginal mesh, please do not hesitate to call our Georgia drug recall attorneys, so we can help you collect the compensation you deserve.

J&J says it has asked the FDA for permission to phase out sales of four of its Gynecare products over the course of several months. It says that will give hospitals and surgeons time to choose other products. J&J has also asked for permission to keep selling Gynecare Gynemesh without further safety studies, but with changes to the label that would restrict its use to abdominal placement rather than transvaginal placement.

J&J announced its intention to halt sales in a letter to the two judges who are overseeing the defective mesh lawsuits against the company. The vaginal mesh products it intends to discontinue are:

  • Gynecare Prolift
  • Gynecare Prolift+M
  • Gynecare TVT Secur
  • Gynecare Prosima

 

If you or a loved one has been injured by defective vaginal mesh and you live in Georgia, please contact or call our Georgia drug recall attorneys at 1-877-LOSS-RECOVER (567-7732). Our successful product liability lawyers will win you the compensation you deserve so that you can move on with your life.

 

 

Unapproved Vaginal Mesh Sold for Over Two Years Before Discovery by the FDA

Gynecare Prolift vaginal mesh went on the market in March, 2005 without approval by or clearance from the U.S. Food and Drug Administration (FDA). Two year later, the agency discovered the problem, but did not penalize J&J. If you have been injured by defective vaginal mesh our Georgia defective transvaginal mesh attorneys can help.

Transvaginal mesh is used in some surgeries to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complications have increased five-fold since vaginal mesh came into use in these procedures.

Clearance for Medical Devices

Many medical devices can go to market without clinical trials and a lengthy approval process. An expedited process called 510(k) requires the FDA to clear new medical devices that are deemed “similar” to devices which have already been approved, even if safety problems were discovered in the older device after it received approval.

J&J did not get 510(k) clearance or any kind of approval for the Gynecare Prolift before it began selling the product. The FDA required the company to apply for clearance after discovering the unapproved device in 2007, but did not pull it from the market while that clearance was pending. The device was cleared in May, 2008, more than three years after it went on the market.

If you or a loved one has been injured by defective vaginal mesh and you live in Georgia, please contact or call our Georgia drug recall attorneys at 1-877-LOSS-RECOVER (567-7732). Our successful product liability lawyers will win you the compensation you deserve so that you can move on with your life.