When surgeons had wanted to perform procedures on women through minimally invasive means, they had opted for a procedure that is called laparoscopic power morcellation. This was intended to achieve the same results as a surgery with an incision, while resulting in an easier recovery period. However, there have been unintended consequences that have accompanied the use of this procedure. In some instances, it has been alleged to have increased a woman’s risk of a cancer diagnosis in the wake of the procedure. This had led to Food and Drug Administration warnings about the safety of the product and procedure. There have been numerous lawsuits that have been brought against both the manufacturer of the product and the doctors who have performed the procedure. If you or someone in your family have undergone this procedure and have been diagnosed with cancer, you should contact an attorney immediately.
How a Morcellator Works
Laparoscopic power morcellators are used during surgical procedures. Their purpose is to take large masses of tissue and make them smaller. The surgeon makes a small incision and can remove the tissue through the incision site. The laprascopic power morcellator works by using sharp edges to finely cut the tissue. It can be inserted through small incision and reaches the site of the tissue since it is a long and hollow cylinder that has cutting jaws on the end of it.
While many of the common uses of these laparascopic power morcellators involve gallbladder and spleen removal surgeries, there were also uses for other surgeries. As applicable here, these devices have been used in procedures such as a hysterectomy and surgery to remove uterine fibroids. The purpose was to shorten recovery times and make it a less difficult procedure.
The Side Effects of a Morcellator
Although there are side effects for gynecological surgeries, the device can have some positive effects for patients. There are several different companies that manufacture morcellators. The two largest makers of the product are Karl Storz GmbH and the Ethicon subsidiary of Johnson & Johnson. Ethicon ceased selling morcellators in 2014. There are several other manufacturers of the product who continue to sell it.
The use of this device for hysterectomies and myomectomies (surgery for uterine fibroids) has caused some severe complications for women who have received the procedure. The major difficulty is that it is difficult sometimes to distinguish between cancerous tissue and a uterine fibroid before the procedure. Given the similarity between the two, telling the difference may often be impossible until the actual tissue can be analyzed. This means that when doctors insert the power morcellator and use it to reduce tissue, they sometimes cannot tell what the actual risks are. If the tissue that is being ground for removal is cancerous, the procedure runs the risk of dispersing cancerous tissues outside of the affected area. In other words, the morcellator takes cancerous tissue, blasts it and disperses it to other places in the body where it takes root and grows into a dangerous and often fatal type of cancer.
The FDA’s Investigation
In the wake of reports of the possibility that laparoscopic power morcellators can increase risk of cancer, the FDA conducted an investigation. The FDA issued a safety communication in 2014 that detailed the risks associated with this procedure. The FDA estimates that between 1 in every 225 and 1 in every 580 women undergoing gynecological surgery may have undetected cancer, causing this risk. Among other things, the FDA required a new boxed warning and for treatment providers to consider other options before using a laparoscopic power morcellator. In the wake of this, Ethicon exited the market for this product. The FDA has sought to discourage the use of this product for several different types of procedures, including hysterectomies. The FDA also recommended several ways, including design and implementation, where this product could be made safer. Now, several companies manufacture morcellators with the use of a containment bag that is intended to prevent cancerous tissue from spreading around the body after it is reduced by the morcellator.
Laparoscopic Power Morcellator Lawsuits
There are two different means that patients have for obtaining compensation for any harms that they may have suffered from laparoscopic power morcellators. The first is a suit against the manufacturer of the device for any defects in the product. The second is a medical malpractice suit against the doctor, especially given that the doctor may not have been able to distinguish between a uterine fibroid and cancerous tissue.
There have been many suits filed against the manufacturers of these morcellators. Some of these lawsuits have alleged that the manufacturers placed into commerce products that were defectively designed. State law product liability grounds have formed the basis for these suits. The plaintiffs have alleged that the manufacturers could have sold a product that was a safer alternative. In addition, the lawsuits allege that the manufacturers knew of the defects related to the product and failed to warn patients of the risks attached to the surgery. In fact, according to the plaintiffs, the manufacturers deliberately concealed the data that was in their possession that indicated that the morcellators caused an increased risk of cancer.
Johnson & Johnson has sought to settle the lawsuits that have been brought against it. In addition, Olympus Corp., another manufacturer of the product, has also settled many of the cases that have been brought against it. There are still hundreds of cases pending in front of courts, although none have gone to trial yet.
In addition, there is also the possibility of filing a claim against the doctor who conducted the surgical procedure. This is arguably medical malpractice given that the cancerous tissue was undetected by the doctor prior to the procedure. If you can prove the doctor was negligent by proceeding to use a laparoscopic power morcellator when the patient had undetected cancer, then you can recovery under a malpractice theory as well. Of course, a doctor can always be joined to a product liability lawsuit as well since the doctor was part of the transaction chain that resulted in a defendant coming into contact with a defective product. It is not your responsibility to prove exactly who is liable, only that you received a defective product. It is for the court to decide exactly who bear the legal liability for that defective product.
It is vital that you contact a lawyer as soon as possible if you have undergone a procedure using a laparoscopic power morcellator to gain a full understanding of your legal rights. Your lawyer can inform you of your prospects of recovery if you have been diagnosed with cancer after your procedure. It is also critically important that you are screened for uterine cancer given the complications that have been experienced.