Washington Injury Attorney Blog

The Food and Drug Administration (FDA) met with medical device manufacturers, representatives of the medical community and health advocate groups today to discuss possible regulation regarding surgical mesh used to treat a pelvic organ prolapse. Surgical mesh is a medical device that has been linked with serious medical complications in some patients.

The recommendation of those at the meeting was to re-classify surgical mesh for pelvic organ prolapse surgery as a class III medical device. A class III device designation means that that the device needs premarket approval to evaluate the device's safety. Premarket approval is a much stricter process than the premarket notification process known as 510(k).

Through the current 510(k) process, manufacturers of medical devices only need to show that their product is equivalent to a device already on the market.

The FDA has received at least 2,000 reports of complications suffered by patients who had surgical mesh implanted trans-vaginally since 2008. In recent months, there have been reportedly 500 product liability lawsuits filed against manufacturers.

Complications associated with the surgical mesh include pelvic pain, incontinence, painful intercourse and infection. Another complication is the fact that the surgical mesh erodes or wears away the tissues surrounding the implant. Some patients have required multiple surgeries.

The Farber Law Group, a product liability law firm located in the Seattle area, represents patients with serious personal injuries due to defective and dangerous medical devices. With our help, you may recover compensation for your damages.

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Continue reading " FDA panel reclassifies surgical mesh for pelvic organ prolapse as a class III device " »

In the past decade, the number of car accident deaths have steadily declined. Unfortunately, that can not be said for pedestrian accidents. Every year, more than 4,000 people are killed in pedestrian accidents and nearly 70,000 pedestrians are injured.

Whether you are running, jogging or walking your dog, you need to be especially careful now that fall is upon us and the days are shorter.

One of the most common sense suggestions for pedestrians is to wear clothes so that you will be seen. A white shirt, a reflective vest and lights made for runners/walkers can help you stay visible. It is amazing the number of pedestrians who just do not make themselves visible.

The National Highway Traffic Safety Administration and the Centers for Disease Control provides the following safety tips for pedestrians:

• Cross at designated intersections where drivers most expect pedestrians.
  
• Pedestrians should be especially careful at intersections. Some drivers may fail to yield or they may fail to notice pedestrians when they make a turn.
  
• Avoid crossing freeways or highways as cars travel at high rate of speeds and pedestrians often miscalculate their ability to cross the highway.
  
• Do not cross train tracks except at marked railroad crossings and NEVER cross tracks unless barriers are not down.
  
• Wear reflective clothing and carry a flashlight.
  
• Walk or jog on sidewalks.
  
• If there is no sidewalk, walk facing traffic.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have been seriously injured in pedestrian accidents due to the negligence of a motorist and the family of those killed. With our help, you may recover compensation for your damages.

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A Leighton, PA, woman, was awarded $23M after she had to have both of her legs and a finger amputated due to a bacteria from a catheter entering her bloodstream.
Sharlee Ann Smoyer, 55, was being cared for at home by a home healthcare nurse, Jolynn Yurchak , under the employee of St. Luke's Miners Memorial Home care. Smoyer's attorney argued that the home care nurse's negligence in failing to report the infection in a timely manner, almost killed Smoyer and cost her limbs due to gangrene.

Smoyer's attorney, Matthew Casey, said:

"Sharlee Smoyer was one of St. Luke's most vulnerable home-care nursing patients and they refused during this trial to accept even the most basic responsibility for mistakes made in her care. Ms. Smoyer hopes that the verdict will result in St. Luke's redoubling its efforts to help prevent catheter-related bloodstream infections in the home-care setting."

The jury found that the home care nurse failed to provide the "standard of care" -- the kind of care that another medical professional would have provided given the same set of circumstances with the same level of education and training.

The medical malpractice award will pay for Smoyer's medical expenses, loss of earnings and for her future care.

The jury was also most certainly sending a message to St. Luke's Miners Memorial Home care to work on preventing catheter-related infections.

Central-line and catheters can introduce bacteria into a patient's bloodstream and can cause death and injuries like Ms. Smoyer's.

National Patient Safety Goals have set standards to decrease and eliminate catheter-related infections. Healthcare workers should be educated on potential complications and how to monitor the catheters and signs of potential infection. Hand washing, body draping, and anti-septic prep before inserting a catheter are all measures that must be taken to prevent infection.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who suffered serious injury due to medical malpractice and hospital infections including MRSA. With our help, you may recover compensation for your damages.

Source:

Jury awards Lehighton woman $23 million
The Morning Call
September 17, 2011

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Pelvic Organ Prolapse (POP) is a medical condition suffered by women where a woman's pelvic organs fall from their normal position and protrude into a patient's vagina. While the condition can occur to any woman, women who have had very long labors or large babies are more prone to the condition. Women who smoke, are obese or have strain injuries are also at increased risk to experience pelvic organ prolapse.

POP was often the cause of a hysterectomy -- removal of the uterus -- in women. Surgeons also have other surgical options which include repairs to the vaginal wall through a transvaginal procedure.

Surgeons have increasingly been using surgical mesh, implanted through the vagina, to repair the prolapse. Surgeons had an option of using a non-absorbable synthetic, an absorbable synthetic or a biolgic to do the repair. However, in most cases, surgeons used a non-absorbable synthetic polyproplene.

The FDA reports that 300,000 women underwent POP repair in 2010 alone and in 75,000 of those cases, surgeons opted for the mesh repair.

Now it has come to light that some women who have had a repair with non-absorbable surgical mesh have suffered some serious and some time debilitating complications.

On July 13, the U.S. Food and Drug Administration issued a notice that with who had the transvaginal mesh repair have a five fold increase of pain and injuries. Last week Public Citizen, a consumer advocacy group petitioned the FDA to have the medical devices pulled off the market.

Up to 600 women with serious injuries have filed lawsuits against some of the leading manufacturers of the surgical mesh including Johnson & Johnson. The lawsuits claim that the manufacturers were negligent in bringing the product to market and did not do due diligence in testing what they say is a defective product. So far, none of the lawsuits have gone to trial.

The Farber Law Group is closely monitoring news feeds from the FDA and keeping abreast of the latest developments. We are a personal injury law firm and we represent people who have been seriously injured by dangerous or defective products .

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In the past couple of years, quite a few medical devices have either been recalled or come under scrutiny after reports of patients being seriously injured or killed due to a defective device. In the case of DePuy's artificial hip implant, Johnson & Johnson's surgical mesh product for pelvic organ prolapse (POP) and the Myxo ETIlogix annuloplasty ring, these devices were approved by the FDA through the 510(k) process which allows new medical devices to come to market through a nominal premarket approval process.

Now, the U.S. Institute of Medicine, a non-governmental non-profit organization which provides unbiased and authoritative advice on science, medical and health issues, is calling for a complete overhaul of the FDA process for approving new medical devices.

A medical device can be a simple tool like a thermometer, bandage or complex such as pace-makers, artificial hips or MRI machines. The FDA is responsible for ensuring that a medical devices have a "reasonable assurance of safety and effectiveness" before it can come onto market. Devices that may pose some risk to patients must be cleared through the Section 510(K) process.

The 510(k) process is a "fast track" through FDA approval and allows manufacturers to claim that a new device is substantially equivalent to other devices and therefore do not require expensive medical scrutiny and clinical trials. In the case of the DePuy hip implant that was recalled, the design was of significant departure from previous hip implant designs but was still given market clearance.

The Archives of Internal Medicine published a study that found that medical devices that resulted in serious patient injury or death were more likely to have been approved by the FDA through the 510(k) process.

On July 29, 2011, the U.S. Institute of Medicine published the results of a study of the FDA approval process which found that the 510(k) process is flawed and rather than trying to fix it, the FDA should develop "an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." (Read the Press Release, "FDA Should Invest in Developing a New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance Process")

Pressure is on the FDA to change the approval of medical devices but also to put in place a system in which problems with the devices are tracked and patient symptoms noted.

Hopefully, the FDA will move forward with insuring patient safety from defective medical devices.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have been seriously injured by defective medical devices and through medical malpractice.

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A U.S. Food and Drug Administration (FDA) advisory panel is meeting next week to discuss problems associated with vaginal repair of pelvic organ prolapse (POP) in women using non-absorbable surgical mesh.

The panel is meeting after Public Citizen, a consumer advocacy group, petitioned the FDA to ban surgical mesh for transvaginal repair of POP.

Tens of thousands of women have suffered serious side effects when their surgeon used a transvaginal technique to implant the mesh. Patients report complications including vaginal tissue erosion, neuromuscular disorders, severe pain, infection, painful sexual intercourse, bleeding and organ perforation. In some cases, women have had to be hospitalized to treat the complications or to have the mesh surgically removed. Surgery to remove the mesh is often complicated because the mesh becomes embedded into the vaginal tissue. Some women have required two or more surgeries.

Public Citizen says that the transvaginal repairs using surgical mesh should be banned because this technique offers no benefits in comparison to other surgical options and because there is a high rate of serious complications, some of which are permanent and life-altering.

Currently, there are several manufacturers that market surgical mesh products for transvaginal repair of POP. These include:

• Gynecare Prolift Total, Anterior, and Posterior Pelvic Floor Repair Systems
  (Ethicon, Inc., Somerville, NJ)
  
• Gynecare Prolift +M Total, Anterior, and Posterior Pelvic Floor Repair Systems
  (Ethicon, Inc.)
  
• Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.)
  
• AMS Elevate Anterior and Apical Prolapse Repair System (American Medical
  Systems, Inc., Minnetonka, MN)
  
• Pinnacle Pelvic Floor Repair Kits (Boston Scientific Corp., Marlborough, MA)
  
• Avaulto Support System (C.R. Bard, Inc., Covington, GA)
  
• Polyform Synthetic Mesh (Proxy Biomedical, Ltd., Galway, Ireland)

The FDA 501(k) premarket notification system, a "fast track" in bringing a medical device to market, is again criticized with this mesh debacle. Like other medical devices, including the DePuy hip implant that has been recalled, surgical mesh systems were allowed by the FDA to come onto the market without clinical data which proved that the devices were safe and effective. All the while, the manufacturers and marketers promoted the devices while tens of thousands of women were harmed.

In recent months, more than 100 women have filed suit against the mesh system manufacturers seeking compensatory and punitive damages. The lawsuits claim that the companies were negligent in the defective product design.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are personal injury law firm that represent product liability and medical malpractice cases. With our help, you may receive compensation for your damages.

Source:Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse, Public Citizen, August 25, 2011

Related Posts: FDA warns about the risk of using mesh in Pelvic Organ Prolapse surgery