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Recent Medical Device News

03-04-2012 FDA Announces Advisory Panel Meeting to Discuss Risks of Metal-on-Metal ImplantsThe FDA scheduled an expert advisory panel meeting for June 27-28 to discuss the risks and benefits of metal-on-metal (MoM) hip implants. The advisory panel will also discuss patient and practitioner...

02-04-2012 Consumer Reports Conclude Insufficient Testing for Medical DevicesAccording to Consumer Reports findings publicized last week, "the majority of medical implants are not tested to make sure they are safe." The report, which was featured in a CBS Investigative...

10-02-2012 Worldwide, Uniform Medical Device Code Awaits Approval in OMBIn an attempt to improve the system of tracking medical devices and the process of recalls, Congress voted for the FDA to "create a uniform device identification system for medical devices." This new...

06-01-2012 FDA Mandates Clinical Trials on MeshResponding to a fivefold rise in deaths, injuries, or malfunctions associated with TransVaginal Mesh devices, the FDA ordered Johnson & Johnson, C.R. Bard, and over 30 other medical device...

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Medical Device Recall is a critical consumer resource providing the public with information pertaining to medical device recalls, warnings, and alerts. We are consumer protection lawyers with decades of experience and have sucessfully represented hundreds of victims harmed by recalled or defective medical devices. If you or a loved one have been injured by a medical device please contact us for a free and confidential review of your potential legal claim.

FDA Announces Advisory Panel Meeting to Discuss Risks of Metal-on-Metal Implants

The FDA scheduled an expert advisory panel meeting for June 27-28 to discuss the risks and benefits of metal-on-metal (MoM) hip implants. The advisory panel will also discuss patient and practitioner recommendations and the treatment and management of patients given these devices.

The devices to be discussed consist of: 1) Metal-on-metal total hip replacement systems consisting of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component); and 2) Metal-on-metal hip resurfacing systems.

Consumer Reports Conclude Insufficient Testing for Medical Devices

According to Consumer Reports findings publicized last week, "the majority of medical implants are not tested to make sure they are safe." The report, which was featured in a CBS Investigative story, revealed that few, if any, medical devices undergo sufficient testing before they are implanted in unsuspecting patients. Instead of following strict approval process procedures, many medical device manufacturers are able to push their products to the market after minimal testing, some paperwork, and a payout of about $4,000 to the Food and Drug Administration (FDA). Many new products are then tested on patients after, rather than before, they are released onto the market - a policy which has undoubtedly led to the recent spike in medical product recalls.

TransVaginal Mesh Suits Consolidated

TransVaginal Mesh – one of the largest medical device controversies this year – is currently the subject of several multidistrict litigations (MDL), three of which were consolidated in a single MDL last month. District Chief Judge Joseph R. Goodwin of U.S. District Court for the Southern District of West Virginia is scheduled to head the proceedings. Defendants will include several TransVaginal Mesh manufacturers such as Boston Scientific, American Medical Systems, Johnson & Johnson’s Ethicon Inc, and C.R. Bard.

J&J Continues to Sell US Rejected Hip Overseas

Last week the New York Times reported that Johnson&Johnson has continued to push its hip replacement product in Europe and elsewhere, even though the product was banned from further sale in the US. The DePuy ASR Acetabular hip replacement system, which was deemed "unsafe" after an unusually high failure rate and formally recalled in August of 2010, was given to approximately 93,000 patients worldwide. Since the recall, Johnson&Johnson has continued to market in this country a similar hip replacement model (which also uses the faulty metal-on-metal components) through a "regulatory loophole that did not require a similar safety review."

Recent Medical Device Recalls & Warnings

LAST YEAR, OVER 437 MILLION DEVICES WERE RECALLED FOR FEAR THEY MIGHT KILL OR PERMANENTLY HARM PATIENTS.

DePuy ASR Acetabular Hip Devices Recalled.

Depuy recalled two of its devices- ASR XL Acetabular system and the ASR resurfacing system- after a publication from the Bone and Joint Registry of England a Whales determined that 1 in 8 patients required revision within the first five years. More info

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TransVaginal Mesh Warning

Recent studies found that TransVaginal Mesh may cause serious vaginal tissue erosion, infection, urinary incontinence, and pelvic organ prolapse in nearly 10% of patients. More info.

Zimmer NexGen Knee Replacement - High Failure Rate.

Zimmer has been under pressure from orthopedic groups to recall its NexGen Knee system, due to issues of failure in its cementless design. The NexGen Knee replacement system could have a failure rate of up to nine percent. More info

Zimmer Hip Durom Cup - High Failure Rates.

Zimmer suspended sales of its Durom Cup due to a unacceptably high failure rate among recipients. Zimmer cited procedural error as cause for the complications and rereleased the device with additional surgical instructions for the Orthopedic surgeons. More info

Diabetes Test Strips Recalled Due to Inaccurate Readings.

FDA issued a recall of several Glucose strips that are used to test the levels of sugar in a patients blood, affected lots suffer from diminished absorption of the blood on the strips and may lead to inaccurate glucose readings. More info

Fentanyl Transdermal Duragesic Pain Patches Recalled.

Duragesic pain patch has recalled fetanyl-release transdermal patch after the FDA determined that users were at high risk of accidental overdose. More info

Ortho Evra Birth Control Patches Linked to Blood Clots and Stroke.

Contraceptive patches were called into question after a dozen blood clot-related deaths, the FDA then issued a warning letter and required Ortho Evra include a stronger warning label. More info

CT Scan Machines Exposing Patients To Dangerous Radiation Levels.

Los Angeles hospital, Cedars Sinai, reported more than 200 patients had been exposed to 8 times the normal amount of radiation after having undergone CT perfusion scans. More info

Did You Know?

Nearly 2,500 medical devices were recalled for potential safety problems in 2008.

71 % of medical devices recalled between 2005 and 2008 were rushed to market (i.e. underwent an abbreviated FDA approval process).

1 in 8 patients who received a DePuy ASR Hip replacement will require revision surgery.

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Medical Device Recall is a consumer resource from lawyers engaged in assisting and representing consumers suffering from recalled or defective medical devices. Medical Device Recall provides important consumer information about the most serious FDA medical device recalls. The medical device products subject to FDA medical device recall are typically recalled from the market because there is a reasonable chance that the medical device could cause serious health problems or death. 1-800-448-5800.
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