Articles Posted in Defective Medical Devices

Insurance carriers are discontinuing coverage of hysterectomies performed with a morcellator. The action comes in response to a warning issued by the U.S. Food and Drug Administration (FDA) in April 2014 about morcellation and cancer cells being spread in the body.

Laparoscopic power morcellators are bladed-tools that that chop the uterus into tiny fragments to be removed through a small laparoscopic incision. If the uterus contains undetected cancer cells, morcellation could spread and upstage the cancer. According to the Journal of the American Medical Association (JAMA), one in 368 women has undetected uterine cancer that could be spread by morcellation.

Following the study, Ethicon issued a worldwide withdrawal from the market, as opposed to announcing an Ethicon morcellator recall.

About a half million American women undergo a hysterectomy each year, according to The Wall Street Journal. Laparoscopic power morcellators are used in about 50,000 of those hysterectomies.

A laparoscopic power morcellator is a minimally invasive tool that was introduced in 1993 to remove the uterus. The blades of the morcellator chop the uterus into tiny fragments so they can be removed through a small laparoscopic incision.

In April 2014, the U.S. Food and Drug Administration (FDA) discouraged doctors from performing hysterectomies and myomectomies – the removal of uterine fibroids-stating that the procedure poses a hidden risk of spreading undetected uterine cancer.

Power morcellators have been used in hysterectomies and myomectomies — the removal of uterine fibroids — for two decades. Morcellation is used to break uterine tissue into tiny fragments for removal.

In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning discouraging doctors from using laparoscopic power morcellators due to the risk of spreading undiagnosed cancer cells. Shortly after the FDA’s warning, Johnson & Johnson (J&J) suspended sales of its power morcellators. Three months later, J&J announced it would withdraw its morcellators from the market worldwide.

Awareness of morcellation cancer risks spread in December 2013 after the Wall Street Journal reported the story of Amy Reed, a Boston anesthesiologist diagnosed with Stage 4 leiomyosarcoma after a morcellation hysterectomy. Amy had undetected Stage 1 cancer that spread during the morcellation procedure.

On July 30, Johnson & Johnson’s (J&J) Ethicon division issued a worldwide withdrawal of its morcellator due to the potential risk of spreading uterine cancer during certain morcellation surgical procedures.

J&J halted sales of its power morcellators in April 2014 after the U.S. Food and Drug Administration (FDA) discouraged the use of the devices and warned about the potential to blast cancerous cells throughout a woman’s body during the removal of the uterus or uterine fibroids.

A morcellator is a laparoscopic device used during a hysterectomy or a procedure called a myomectomy to remove uterine fibroids. The morcellator divides the uterine tissue into smaller pieces so it can be removed through a small incision in the abdomen.

Thoratec Corp. issued an urgent safety advisory about the HeartMate II LVAD Pocket System Controller for its mini heart pump after four patients died and five others were injured.

The notice includes new information and labeling for the controller, which has been prescribed to 2,142 patients since August 2012. It helps operate the company’s HeartMate II left ventricular assist device (LVAD), which takes over for a failing heart.

“Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated patient handbook information,” the company said.

Last Month, the United States Senate Finance Committee reported that medical device manufacturer, Medtronic, Inc. paid authors over $200 million to manipulate the data reported in medical studies. Medtronic paid these industry leaders to promote Infuse bone graft for uses not approved by the Food and Drug Administration (FDA) which violates the agency’s regulations.

Infuse Bone Graft is a genetically engineered product that converts stem cells into bone cells. Designed to grow bones, Infuse is made up of three parts: recombinant engineered human bone morphogenetic protein-2 (RhBMP-2), a sponge manufactured from bone Type 1 collagen which is a natural carrier for delivery, and a cage which holds the BMP-soaked sponges that gradually release and reabsorb the protein.

Infuse was approved by the FDA in 2002 for use in dental, oral and spinal surgeries with an anterior (frontal) approach. Infuse was not approved for anterior (back) approach spinal surgeries, because too many patients experienced complications in the 1999 clinical trials.

Some neck surgeries and other types of procedures in which Infuse was used were performed “off-label,” which is the term applied to describe the use of a product for a reason other than its intended purpose. . Some operations were anterior approach spinal surgery.

The FDA permits doctors to use drugs and medical devices off-label as they see fit. However, medical device manufacturers are prohibited from promoting off-label use.
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According to a recent article in the New England Journal of Medicine, more than 500,000 patients in the United States have received metal-on-metal hip implants, most of which were implanted between 2003 and 2010. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip implants made from other materials.

On June 27-28, 2012 the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee seeking expert scientific and clinical opinion on the risks and benefits of metal-on-metal hip systems including:

• Failure rates and modes;

Is the FDA system broken? Manufacturers of hip implant medical devices don’t have to go through clinical trials like prescription drugs. All these metal on metal hip implant makers have to do is – to establish that the hip implant is substantially equivalent to other devices already on the market in order to gain approval.

That’s good news for the billion-dollar medical device makers and their investor relations but bad news for people like you who need hip replacements and the doctors who implant them. It doesn’t take much to get a hip replacement on the market. Does it practically take an act of God to get the device removed from the marketplace?

Something is terribly wrong when a dangerous medical devices like metal on metal hip implants are introduced and marketed over and over again with the same set of flaws and side effects or worse set of flaws and side effects.

Take an informal survey of friends and family who have had hip implants. Ask what brand of hip implant do they have? Most likely blank stares will be the answer. Some may know metal on metal, metal on polyethylene, or metal on ceramic hip replacements, but most will be unaware of the brand or model.

You can jog their memories with Stryker, DePuy, Zimmer, Pinnacle, Biomet, and Wright among others though no recollection comes to mind. Yet, if you ask what brand of contact lenses or dental adhesive they use – brands easily roll off the tongue. Why so? Perhaps, brand recognition occurs because the contact lenses or dental adhesive packaging is personally handled and rests in the medicine cabinet.

Would a patient who has had a hip implant actually know the brand? Would you know the difference between primary acetabular components and primary femoral components? The answer is most likely no, unless you have reviewed your complex medical records.

So, as hip replacement patients, when you hear on TV or read on online about all the hip implant complications, what can you do?

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Over the years there have been several hip implant recalls. While there is not one blanket hip implant recall for all types of hip replacement devices, some recent recalls have focused on specific models of metal on metal hip replacements.

FDA hip replacement complaints and medical device study data led to two DePuy hip replacement recalls in August 2010, for example. The 2010 recalled devices included the DePuy ASR ™ XL Acetabular System and the DePuy ASR ™Hip Resurfacing System. Both devices were found to have higher failure rates than other types of hip replacement systems.

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