Category: Medical Devices

Posts related to Medical Devices

FDA Strengthens Rules On Transvaginal Mesh

Women Filing Lawsuits Now Due To Injuries Suffered After POP Treatment

This week the FDA responded to concerns about the safety of mesh implants to treat pelvic organ prolapse (POP) in women. They have been reclassified with its highest risk category and manufacturers of existing products must submit premarket approval applications within 30 months. According to a statement by the FDA, the applications are required “to support the safety and effectiveness” of the mesh products.

POP is caused when the bladder, bowel and uterus are no longer supported by weakened or stretched pelvic floor muscles. Women may develop POP as a result of childbirth, hysterectomy, or menopause. If left untreated, POP can cause pain and urinary leakage.

SurgeryIn the 1990s, gynecologists started using surgical mesh transvaginally to repair POP, reinforcing pelvic muscles and reducing recuperation time. The FDA okayed the [...]

New Study Shows Risk Of Second Vaginal Mesh Surgery

1 in 30 Women May Need Revision Surgery
medical device

Approximately 1 in 30 women opting for vaginal mesh surgery to treat urinary stress incontinence will have to either remove or replace the mesh within 10 years according to this study.

On September 9, 2015, JAMA Surgery published online the results of a 10 year study at Western University in Ontario, Canada. Researchers followed the results of 59,887 women who had mesh implanted by around 1000 surgeons over the course of the study. The data showed that after 5 years, 2.2% needed a revision surgery while the number increased to 3.3% after 10 years. This means a woman’s odds of needing to have a second mesh surgery could be 1 in 30.

One interesting conclusion noted by the researchers is that the patients of surgeons who did higher volumes of mesh surgery had better outcomes. Apparently, it doesn’t seem to matter if the surgeon specialized in gynecology or in [...]

Congress Questioning FDA Over Power Morcellator’s Risk To Women

Use Of This Device May Spread Cancer Cells After Hysterectomy And Uterine Fibroid Removal Surgeries
medical device

Last Friday 12 members of the US Congress sent a request to the US Government Accountability Office (GAO) asking them to investigate the FDA’s monitoring of a potentially dangerous gynecological device. The laparoscopic power morcellator, has been in use since 1993. The tissue dissecting tool has been linked to the spread of cancerous cells in hysterectomy or uterine fibroid removal surgeries.

The letter from Congress stated that, “Hundreds, if not thousands of women in American are dead because of a medical device known as the laparoscopic power morcellator.” The members of Congress are concerned as to why the power morcellator was widely used for 20 years before the FDA issued safety warnings about the possible hidden cancer risk.

When the FDA first approved the device in 1993, they concluded that the risk was small with only about 1 in 10,000 women having the hidden cancer cells that might be spread. In late 2013, after reviewing [...]

Man Awarded $9.1M For Defective Zimmer Hip Implant

Update On Hip Replacement Litigation
Hip Implant


Last week a Los Angeles jury awarded over $9 million to a man that had received a Zimmer Durom Cup hip implant in 2007 and had to have it removed a little over a year later due to failure of the hip replacement. Hundreds of other cases against the company because of its metal-on-metal hip implant are pending.

The plaintiff claimed that Zimmer was negligent in failing to warn the public about design defects in the Durom Cup hip replacement system which was removed from the US market in 2008.

Zimmer Biomet, which is based in Warsaw, Indiana, is only one of the companies currently being sued because of their hip replacement systems. Others include DePuy Orthopaedics, Inc. and Stryker Corp.

DePuy and Stryker Settlement Programs

DePuy which is a unit of Johnson & Johnson, recalled their ASR XL Acetabular Hip Systems and ASR Hip Resurfacing Systems. After settling some of these metal-on-metal hip system [...]


Legal Help For Women Harmed By The Mirena IUD

Many women are now turning to legal experts after experiencing severe complications as a result of using Mirena.

What is Mirena?

Mirena (Levonorgestrel) is an intrauterine contraceptive system (IUD) approved for women who have already had at least one child. It’s made of a soft, flexible plastic with a string or “tail” also made of plastic and is placed by a medical professional.

This birth control device contains the female hormone, levonorgestrel.  Available only by prescription, it is placed in the uterus where it slowly releases the hormone.  When it is in place, Mirena stops a woman’s egg from fully developing which prevents fertilization by a sperm and prevents pregnancy.  Once implanted, the system can be left in place for up to five years and is more than 99 percent effective at preventing pregnancy.

The U.S. Food and Drug Administration (FDA) also approved Mirena for use to treat heavy menstrual bleeding, primarily [...]

Mirena IUD lead to growing number of lawsuits

Women have been harmed by the Mirena IUD

Houston, TX March 15, 2013 – Mirena lawsuits continue to mount as more women are made aware of the dangerous injuries associated with the use of the IUD. The lawsuits allege that Bayer Healthcare Pharmaceuticals overstated the efficacy of Mirena while understating the potential safety concerns of the device. Plaintiffs claim they suffered serious injuries after the IUD perforated the uterine wall and migrated from its original position, which resulted in surgery to have the device removed.

Mirena was approved for contraception by the U.S. Food & Drug Administration (FDA) in 2000. The small, plastic t-shaped device contains the hormone levonorgestrel and is inserted into the uterus by a healthcare provider, where it may remain for up to 5 years. In 2009, the FDA cited Bayer for its Mirena promotions, stating they were misleading and downplayed risks associated with the device. Since being approved, there have been thousands of serious adverse complications reported to the [...]

Injured Because Of A Defective Hip Replacement Or Medical Device?

Medical devices are implanted in the patient usually by way of invasive, painful surgery or injection. Some such as hip implants, knee implants, or transvaginal mesh products become a part of the patient’s body. When the medical devices stop working as expected or causes harm, it is not a simple matter to repair or heal. In most cases, another invasive, painful revision surgery is required. This can result in extended recovery time and additional costly therapy. In certain cases, the defective device might cause permanent damage either to the patient’s organs or bones which may make recovery difficult if not impossible. Their quality of life may be less than they experienced prior to having the medical device implanted initially. Manufacturers of medical devices are expected to test all devices before releasing them to the public, but sometimes the premarket studies do not include enough [...]

DePuy Hip Replacement Lawyer

If you have had a hip replacement, you may need a DePuy hip replacement lawyer. On August 26, 2010, DePuy Orthopaedics, Inc. officially recalled two defective hip implant systems, the ASR Hip Resurfacing System and the ASR XL Acetabular System. The recall was ordered by the U.S. Food and Drug Administration (FDA) after receiving a high volume of complaints from patients that had received one of these defective DePuy hip implants. The New York Times* recently called the DePuy hip implant recall “The most widespread medical implant failure in decades.” After the recall, thousands of the estimated 93,000 all-metal hip replacement patients contacted a DePuy hip lawyer to find out if they may have a claim against the hip implant manufacturer. DePuy is a subsidiary of Johnson & Johnson.

The DePuy ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System have a 12 to 13 percent chance of [...]

You may need a Zimmer Hip Replacement Lawyer

Many patients treated with a Zimmer hip replacement are contacting a lawyer to see if they may have a claim for compensation.

The British Medical Journal (BMJ) along with BBC Newsnight recently published their results from an investigation on metal-on-metal implants such as the Zimmer hip replacement. The metal-on-metal Zimmer hip replacement may have exposed thousands of patients to toxic compounds due to their chromium-cobalt alloy. The grinding of the metal parts of the Zimmer hip replacement system can create metal debris and release toxic ions in the bloodstream. This can lead to damage to the surrounding tissue, muscles and bones in the hip area. There is some concern that the metal poisoning might also raise the risk of developing cancer or altering the patient’s own DNA.

The report stated that the manufacturers of the metal-on-metal hip implants, including Zimmer hip replacement systems and DePuy’s [...]

Stryker Hip Replacement Lawyer

You may need to contact our Stryker hip replacement lawyer today to see if you may have a claim for compensation.

Latest News on Stryker Lawsuits

Many of the initial test cases or “bellwether” cases have successfully settled. As a result, a second phase is now being planned in part due to the positive outcome experienced in the belwether cases and the settlements reached late in 2013 of 8000 DePuy metal hip cases.

It’s possible however, that Stryker may not settle cases of those patients that have not had a revision surgery. If you have, or think you may have a hip implant claim, do NOT feel that you must have a revision surgery based on our information. We are not medical experts and cannot begin to advise you on how to be treated. We do however, remind you of the importance of maintaining regular follow-ups with your orthopedist [...]

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