Atlanta Personal Injury Lawyer - Medical Devices

Medtronic Recall given FDA’s most Serious Score

Jessica Smagacz — Sun, 14 Jun 2009 14:59:05 GMT

This past Thursday, FDA said that thousands of Medtronic pacemakers may potentially cause serious injury or death, according to AP.

The pacemakers may have wiring defects that can cause them to malfunction. Medtronic is the world’s largest medical device company. There are 37,000 pacemakers that have this wiring defect.

FDA has classified this pacemaker as a Class I recall. This means that the device could “seriously or fatally injure patients.”

There are about 1.7 million of these pacemakers that have been implanted since 1997. “The defects affect a small subset of Kappa and Sigma pacemakers, causing them to not respond or run out of batter power.”

Over 95 percent of doctors were notified about this problem and have confirmed their receipt of the Medtronic’s letter.

“Patients should seek medical attention immediately if they experience fainting or lightheadedness, the company said in a statement.”

Originally posted at InjuryBoard by Jessica Smagacz

STAR System Approved by FDA

Jessica Smagacz — Fri, 29 May 2009 10:02:15 GMT

FDA recently approved a total ankle replacement system, the Scandinavian Total Ankle Replacement (STAR) system.

STAR may preserve some range of motion in arthritic or deformed ankles, according to the Atlanta Journal-Constitution.

This is the first type of system approved for ankle deformities or like injuries of the ankle. STAR uses bearings that move across a surface of flexible plastic (polyethylene).

When someone is experiencing or has arthritic or a deformed ankle, they may undergo a surgery called Fusion surgery. Fusion surgery is where the shin bone is cemented to the talus bone in the ankle. This surgery is suppose to stabilize the ankle but adversely decreases a patient’s ability to move their foot up and down.

The STAR system is an alternative and allows feet to move.

Director of the FDA’s Center for Devices and Radiological Health, Dr. Daniel G. Schultz said, “This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle. For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”

FDA executed a two-year study of 224 patients in order to approve the STAR system. The study found similar rates of adverse events, surgical interventions and major complications as fusion surgery.

Small Bone Innovations of Pennsylvania agreed to evaluate the safety and effectiveness of this medical device over the next eight years as a condition FDA offered in order to approve the STAR system.

Originally posted at InjuryBoard by Jessica Smagacz

FDA not enforcing medical device safety standards

Jessica Smagacz — Wed, 18 Feb 2009 23:34:06 GMT

The Associated Press reported today that an independent watchdog group said FDA “has quietly scaled back enforcement of federal quality regulations at labs that develop medical devices.”

FDA has reduced the inspections of “good laboratory practices” considerably at facilities that conduct the earliest testing of medical devices. The inspections went from 33 in 2005 to 7 in 2007. Last year it went to one inspection.

The medical devices included range from imaging machines to pacemakers. The initial testing process is where these medical devices are tested in labs using specialized machinery or animals.

A nonpartisan group, the oversight project, said in the report, “The decision … to not enforce (lab standards) is stunning in its contempt for the protection of patients.”

The main center overlooking medical devices is called the Center for Devices and Radiological Health, a division of the FDA. Apparently, there have been complaints from FDA’s own scientists “that managers squelched debate, leading to the approval of devices that were of questionable effectiveness and perhaps not entirely safe.”

Right now, according to the oversight group, manufacturers are still required to abide by lab standards and must certify this in writing that they do abide by the standards.

Originally posted at InjuryBoard by Jessica Smagacz

Some Medical Devices Approved without Scientific Review

Jessica Smagacz — Fri, 16 Jan 2009 11:43:03 GMT

FDA has approved 228 medical devices without full scale reviews from the years 2003-2007 according to a report by the Government Accountability Office reports Fox News. This happened even though Congress ordered FDA years ago to resolve this particular issue.

As a result of no full scale review, some of the medical devices approved have been recalled because of malfunctions. Fox news reports one of the devices was an external defibrillator to assist heart attack victims.

Rep. Frank Pallone, head of the House of Energy and Commerce Committee’s health panel said, “GAO’s investigation confirms my concerns that the approval process for medical devices is woefully inadequate. For years Congress has required high-risk medical devices to undergo stringent premarket review, but GAO’s findings show that is simply not happening in every case.”

FDA is the root of the problem seeing as they never carried out the change of law when Congress ordered them to resolve this issue.

For devices that are low-risk (reading glasses or bandages), they can get cleared by notifying FDA before going to the market. The process is different for high-risk devices such as heart valves or pacemakers. These devices should go through a higher, tighter scrutiny. The manufacturers are required to prove with evidence that the medical devices are safe and effective. However, an exception was made for new versions of the high-risk medical devices already on the market. Apparently, “manufacturers could get approval by convincing the FDA that these devices were ‘substantially equivalent’ to their precursors. In 1990, Congress ordered the FDA to end the practice, but it has continued even as generations of technology have come and gone.”

FDA is aware of this problem and has not set a time for resolving it. The report urges the FDA to “promptly resolve the problem.”

If FDA continues to allow medical devices into the market without undergoing a tighter scrutiny review, “it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen’s health research group.

Originally posted at InjuryBoard by Jessica Smagacz

FDA Recall of Ophthalmic Surgical Device

Jessica Smagacz — Mon, 05 Jan 2009 12:07:56 GMT

FDA announced a recall on January 2 of UD 30654 of Healon D, an ophthalmic viscosurgical device (OVD). This device is manufactured by Advanced Medical Optics Inc. of Santa Ana, California.

On October 30, 2008, Advanced Medical Optics Inc. voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D. They recalled this product because they received complaints of inflammation after eye surgery including Toxic Anterior Segment Syndrome (TASS).

OVDs, FDA explains, are viscoelastic materials that are used to maintain space in the eye during surgery. They are typically applied using a small tube.

When the company initially recalled these products, they informed customers of the number and nature of the adverse event reports associated with the product.

By December 2, 2008, Advanced Medical Optics Inc. retrieved only 964 units out of the 1,450 distributed in the US.

Advanced Medical Optics Inc. received 66 adverse event reports associated with OVD! Tests were completed on these products and they revealed elevated levels of endotoxin (associated with post-operative intraocular inflammation and TASS). TASS is an acute inflammation of the eye that occurs after operation.

FDA is urging anyone who has possession of these units to remove them from inventory and contact Advanced Medical Optics Inc. at 1-877-AMO-4Life in order to make arrangements for return.

Originally posted at InjuryBoard by Jessica Smagacz

FDA Class 1 Recall: Stryker Cranial Implants

Jessica Smagacz — Wed, 31 Dec 2008 10:47:38 GMT

Stryker Leibinger USA, a firm based in Portage, Michigan, is recalling it Stryker Custom Cranial Implant kits product. FDA reported this product as recalled on October 24, 2008.

The products use: This product was used to correct trauma and or defects in the lower jaw, upper jaw and face or the cranium and face.

Reason for recall: Stryker is recalling this product because sterility cannot be assured.

Contact information: 269-324-5346, ext. 4258.

The company was notified of the problem before October 24; the letter advised them of the risk of serious infections.

FDA called this a class 1 recall. Class 1 recalls are “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.”

FDA advises consumers and health care professionals to report adverse reactions or quality problems experienced to FDA’s MedWatch Adverse Event Reporting.

Originally posted at InjuryBoard by Jessica Smagacz

Do you have PAGCL?

Jessica Smagacz — Sat, 08 Nov 2008 16:44:35 GMT

PAGCL stands for Postarthroscopic Glenhumeral Chondrolysis. PAGCL is a condition caused by the deterioration of cartilage around the shoulder area.

Recent studies have suggested the use of pain pumps implanted in the shoulder during surgery are linked to the development of PAGCL.

Please see our past blog on Pain Pumps Found to Lead to Permanent Shoulder Cartilage Damage.

According to Resource For the People, pain pumps are commonly used in the medical field as a solution for pain management. These pain pumps are used in arthroscopic surgery (designed to be less encompassing of the human body) that consists of two incisions. This procedure is quicker and the pain treatment and surgery is less complicated.

Although quicker and less painful, the use of these pain pumps suggests a correlation to PAGCL condition. This is a condition that is suggested to be irreversible. The only solution is to have another shoulder replacement surgery.

What should you do if you have developed PAGCL?

You need to consult your doctor immediately. Your doctor can recommend medication and the next steps to handle this condition. Additionally, you may want to consider contacting the attorneys at Childers, Buck, and Schlueter to see how they can help protect your legal rights.

Originally posted at InjuryBoard by Jessica Smagacz