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Uterine Fibroid Procedure May Cause Cancer, FDA Warns

The U.S. Food and Drug Administration (FDA) advised doctors on Thursday to stop using power morcellators in laparoscopic uterine fibroid removal surgeries because of cancer concerns. The agency said the surgical technique could unexpectedly spread cancerous tissue into a patient’s stomach.

The FDA recommended that doctors look into other treatment methods for symptomatic fibroids rather than using the tool to remove fibroids or a woman’s uterus laparoscopically, according to Law360. Despite the severity of the risks, the agency didn’t remove the nearly two-dozen power morcellators from the market. More Uterine Fibroid Procedure May Cause Cancer, FDA Warns

Intuitive Sales Drop as Da Vinci Lawsuits Pile Up

In a year where Intuitive Surgical has issued a series of recalls and been hit with an influx of lawsuits, the company is also seeing financial woes.

Intuitive announced its first-quarter revenue declined about 24 percent as sales of its robotic surgery system took a plunge. In a statement released by Intuitive, the company said it shipped 87 robots in the first quarter compared with 164 a year earlier. Intuitive also suffered a charge of $67 million to reflect estimated costs of settling product liability claims. Most of the claims are related to alleged complications from surgeries performed with certain robotic scissors or tip covers that have since been taken off the market, Bloomberg News reported. More Intuitive Sales Drop as Da Vinci Lawsuits Pile Up

Battery Defect in Ventilators puts Patients at Risk for Unexpected Lapse in Ventilation

Evita V500 and Babylog VN500 ventilators are being recalled by the Pennsylvania-based company, Draeger Medical, due to battery issues that could put patients at risk. The U.S. Food and Drug Administration (FDA) gave the recall their highest-risk Class I label.

The batteries installed in the Evita V500 and the Babylog VN500 ventilators may suddenly fail without triggering alarms or indicating a low battery supply, which puts patients at risk for an unexpected lapse in ventilation that could result in injury or death. There may be no indication of a diminished battery until all power is lost, according to MassDevice.com More Battery Defect in Ventilators puts Patients at Risk for Unexpected Lapse in Ventilation

Woman Files Lawsuit Against Biomet Over Defective Metal Hip

A lawsuit has been filed on behalf of a Colorado woman, alleging her Biomet metal-on-metal hip implant is defective and caused serious complications.

The lawsuit was filed by the national law firm of Parker Waichman LLP in the U.S. District Court for the Northern District of Indiana, South Bend Division and names Biomet, Inc. and Biomet, Orthopedics, LLC as defendants. The case will be part of the multidistrict litigation (MDL) before the Honorable Robert L. Miller, Jr. More Woman Files Lawsuit Against Biomet Over Defective Metal Hip

Jury Awards $1.2 Million to Plaintiff in J&J Transvaginal Mesh Case

A Texas jury has ordered Johnson & Johnson to pay $1.2 million to a woman who sued over one of the company’s lines of transvaginal mesh implants, Bloomberg News reports. The lawsuit, filed by 64-year-old woman Linda Batiste, alleged that the mesh device was flawed and caused serious injuries. Pelvic mesh implants are used to treat incontinence or sagging pelvic organs. Batiste’s alleges in her lawsuit however, that the device eroded inside her and caused pelvic pain.

More than 12,000 transvaginal mesh lawsuits are pending against Johnson & Johnson’s Ethicon unit over the company’s pelvic mesh devices. Plaintiffs allege that the transvaginal mesh causes severe complications, such as organ damage and painful sex. Most cases have been filed into the federal multidistrict litigation (MDL) underway in West Virginia.

Bloomberg reports that in Dallas state court, jurors concluded the TVT-O mesh sling was flawed and that Batiste deserved $1.2 million in compensatory damages. Last year, J&J was ordered to pay $11.1 million in damages to a woman who sued over the company’s Prolift device.

In 2010 alone, over 70,000 mesh devices were inserts in the United States to help strengthen pelvic muscles or support internal organs. As many of the lawsuits point out, such devices were never clinically tested before they were approved for sale.

J&J is not the only device maker facing litigation over transvaginal mesh. Many other manufacturers, including C.R. Bard, Boston Scientific and American Medical Systems are also being sued by women allege that the mesh implants are defective. Some of these cases have been filed into the West Virginia MDL, while others are filed in state courts across the country.

Due to safety concerns and mounting litigation, the U.S. Food and Drug Administration (FDA) has ordered J&J and 32 other device makers to study the rates of organ damage and other complications associated with pelvic mesh implants. In 2011, the agency also warned that complications are “not rare” and cautioned that the devices may be more harmful compared to other methods of treating pelvic organ prolapse.

In the federal MDL, a Magistrate judge found that Johnson & Johnson negligently lost or destroyed documents related to the transvaginal mesh litigation. Last week, a consumer advocacy group asked U.S. attorney general Eric Holder Jr. to open up a criminal investigation into the destruction of documents.

Thoratec’s HeartMate II Implantable Heart Pump is Subject of Class I Recall

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of Thoratec’s HeartMate II implantable heart pump.  A Class I is the agency’s most serious recall classification and is reserved for devices that have the potential to kill or seriously injure patients.

Five patients have been injured by the HeartMate II and four deaths were reportedly associated with a defect in the heart pump’s controllers. According to the company’s warning, the dead and injured patients did not receive adequate training on how to switch from an old controller to a new one. The controllers help circulate blood throughout the body, allowing the heart – which may be too weak to pump the blood on its own – to work less, MassDevice.com reported. More Thoratec’s HeartMate II Implantable Heart Pump is Subject of Class I Recall

Coloplast Agrees to Pay $16 Million to Settle Pelvic Mesh Lawsuits

Medical device maker Coloplast has agreed to pay about $16 million to settle lawsuits filed against the company by women who allege they were injured by its pelvic mesh products.

The Denmark-based company agreed in January to resolve about 400 lawsuits filed over the mesh inserts, which would provide a payment of approximately $40,000 for each claimant, according to Bloomberg.com. More Coloplast Agrees to Pay $16 Million to Settle Pelvic Mesh Lawsuits

Consumer Group Urges Attorney General to Investigate Ethicon

A consumer advocacy group is urging U.S. attorney general Eric Holder Jr. to launch a criminal investigation into accusations that Johnson & Johnson (J&J) subsidiary Ethicon destroyed documents in lawsuits filed over its pelvic mesh products.

Corporate Action Network sent an open letter to Holder calling for the probe into the documents’ destruction, MassDevice.com reported. Earlier this year, a federal judge found that Ethicon lost or destroyed a series of documents connected to its the multi-district litigation over its pelvic mesh devices. More Consumer Group Urges Attorney General to Investigate Ethicon

Biomet Settles M2A Magnum Metal Hip Lawsuits for $56 Million

Biomet Inc. announced that it will be pay at least $56 million to settle a multidistrict litigation involving its defective metal hip implants.

The lawsuit was filed on behalf of patients who allege injuries resulting from the M2a Magnum Hip Replacement System. The lawsuit claims that the device maker manufactured a defective metal-on-metal hip implant device that may lead to serious metal ion build-up in patients’ bodies. The litigation also involved allegations that the device may lead to metallosis (metal poisoning), difficulty walking, pain, and premature hip failure. These issues can lead to costly and painful revision surgeries to remove or replace the device. More Biomet Settles M2A Magnum Metal Hip Lawsuits for $56 Million

Stryker Settles Eight Rejuvenate Hip Lawsuits

Stryker has begun settling a portion of the more than 1,000 lawsuits it faces over allegations it sold faulty hip implants that injured patients.

According to FierceMedicalDevices.com, the company has reached a settlement with eight plaintiffs who filed a lawsuit against Stryker’s Rejuvenate metal hip implant. That represents a vast majority of the nine cases ordered into a mediation process at Superior Court of New Jersey for Bergen County. Since the cases have been resolved, 10 new cases will be added to the mediation. More Stryker Settles Eight Rejuvenate Hip Lawsuits