The FDA says that serious complications have been linked to surgical mesh that is implanted in the body to repair pelvic organ prolapse and stress urinary incontinence. While the federal agency had issued an early warning in October 2008 about health risks linked with using this medical device to treat SUI and POP, now the government wants surgeons and patients to know that serious complications are not rare. Also, the FDA says that it is unclear whether transvaginal POP repair using mesh is in fact more effective than opting for non-mesh repair to treat the same pelvic problems.

If you or someone you love suffered the following complications after undergoing transvaginal POP repair using surgical mesh, do not hesitate to contact our Charlotte, North Carolina defective medical device law firm today:

• Mesh erosion through the vagina
• Infection
• Pain
• Dyspareunia
• Urinary problems
• Organ perforation
• Bleeding
• Neuro-muscular problems
• Vaginal scarring
• Vaginal shrinkage
• Emotional issues

The FDA says that it has received more than 2,000 reports of complications from use of surgical mesh. Many of these reports came from the manufacturers of these devices. Some patients had to undergo additional surgeries and hospitalization and experienced impaired quality of life.

Our North Carolina transvaginal mesh lawsuit law firm cannot stress how important it is for manufacturers to make products that will not cause injury or other health complications for a patient. With so many women suffering from some type of pelvic prolapse—the Los Angeles Times reports that up to 50% of all women end up suffering from this condition, which involves organs (bladder, uterus, bowel, rectum, or intestines) slipping out of place following a hysterectomy, menopause, childbirth, or with age—this condition requires treatment more often than one would think. Some 75,000 such procedures are conducted annually.

Mesh used in pelvic surgeries under scrutiny, Los Angeles Times, July 25, 2011

FDA warns against surgical mesh to repair pelvic problems, Boston.com, July 13, 2011

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, FDA, July 13, 2011

Related Web Resources:
Pelvic Organ Prolapse, American Urogynecologic Society

Stress incontinence, MedlinePlus

More Blog Posts:
Approximately 1,000 DePuy Hip Lawsuits Already Filed Against Johnson & Johnson, North Carolina Injury Lawyer Blog, July 7, 2011

Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011

According to The Wall Street Journal, about 1,000 defective medical device lawsuits have been filed in federal and state courts accusing Johnson & Johnson of continuing to make its metal-on-metal hip joints even while knowing that there were problems with some of them. J & J’s DePuy Orthopaedics Inc. finally recalled the hip replacement devices last year, while promising to cover all medical expenses incurred as a result of problems with the device. If you believe that the pain that you or a love one is experiencing is because of a DePuy hip implant, contact our Charlotte, North Carolina DePuy defective medical device lawyers today.

The 2010 recall included about 93,000 artificial hips—the ASR XL Acetabular Hip Replacement product and the ASR Hip Resurfacing Systems—over concerns that their failure rate was too high. The National Joint Registry of England and Wales had found that within five years of hip replacement surgery with a DePuy product, 1 in 8 patients had to undergo a revision surgery because the medical device had failed. According to J & J, about 37,000 patients in the US and approximately 93,000 patients globally had received a recalled DePuy hip device. Those who have contacted DePuy since the recall was announced have complained of inflammation, infection, pain, and cobalt and chromium, which are both potentially toxic metals appearing in the blood stream.

Going through hip replacement surgery once is uncomfortable and disruptive enough without having to do it again because the implant used was defective or failed. Not only are there risks involved anytime one undergoes surgery, but the recovery time is often long and other health complications can result.

Hip Joints Set Off New Rush to Court, The Wall Street Journal, July 8, 2011

DePuy Hip Recall Guide

New DePuy hip implant gets FDA approval amid lawsuit over old one, MEDCity, June 17, 2011

National Joint Registry of England and Wales

More Blog Posts:
Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011

DePuy ASR Hip Replacement Products Recalled, North Carolina Injury Lawyer Blog, September 16, 2010

Johnson & Johnson Recalls Defective Duragesic Pain Patches, North Carolina Injury Lawyer Blog, January 5, 2009

According to a report in the Archives of Internal Medicine, there are questions as to whether the Food and Drug Administration is doing a good enough job of protecting Americans from defective medical devices. This is obviously an issue of concern for patients, as well as for our Charlotte, North Carolina defective medical devices attorneys who are familiar with how dangerous faulty/malfunctioning devices can be for patients.

Researchers looked at 113 devices that the FDA recalled between 2005 and 2009. The recalls were issued because of the health risks the devices posed. It now appears that 71% of these devices were approved without ever being tested on people—primarily because they were considered similar enough to at least one other product already in the marketplace. Just 19% of the products had to go through tougher review.

The FDA’s less strict approval process, which attempts to get medical devices out there sooner rather than later, is hurting patients. Yet, according to the Washington Post, seeing as over 19,000 medical devices were approved during those four years, there really weren’t that many recalls issued. FDA spokeswoman Karen Riley noted that many people have benefited from the approval of many of these medical devices. She did also say, however, that the researchers’ findings show a need for better safeguards. The agency is making 25 changes to ensure this.

While it is true that medical devices can save lives, defective ones have also been a source of serious injury and death. It is important that manufacturers make sure their products are safe before releasing them into the market and that the government does its job by checking to make sure a medical device is safe before placing its stamp of approval on it.

Examples of defective medical devices:

• DePuy Hip Replacement Systems
• Guidant Cardiac Defibrillator
• Medtronic Defibrillators
• Duragesic Pan Patch
• Nuvaring
• Knee Implants
• Guidant Pacemakers

Study of recalled medical devices faults lax FDA testing methods, The Washington Post, February 15, 2011

Medical Device Recalls and the FDA Approval Process, Archive of Internal Medicine, February 14, 2011

Related Web Resource:
US Food and Drug Administration

Related Blog Posts:
Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People, North Carolina Injury Lawyer Blog, November 24, 2010

Medical Device-Related Complications Send Over 70,000 Children to the ER Every Year, North Carolina Injury Lawyer Blog, November 24, 2010

Supreme Court Places New Limits on Products Liability Lawsuits Filed Against Medical Device Manufacturers, North Carolina Injury Lawyer Blog, February 20, 2008

A new report published in BMJ, a British medical journal, is questioning the US Food and Drug Administration’s ability to keep defective and dangerous medical devices out of the market. The paper contends that inadequate manpower, an insufficient budget, lack of authority, and the agency’s co-opting by special interests, medical devices makers, and political forces are rendering the FDA unable to do its job to protect the public.

The authors of the study, Dartmouth Institute for Health Policy and Clinical Practice instructor Shannon Brownlee and medical investigative journalist Jeanne Lenzer, talk about the deficiencies in the FDA’s post-approval surveillance process. For example, since the agency approved the vagus nerve stimulator (VNS) by Cyberonics 13 years ago, there have been reports of approximately 900 deaths involving people that used the medical device. The FDA still does not know what caused these fatalities or if a VNS even was a cause of death. Some 60,000 people are currently using a VNS, which is designed for treating epilepsy and is also approved treating depression. Cyberonics is seeking to widen the approval for VNS so that it can be used for treating traumatic brain injury, stroke, and obesity.

Recently, the FDA took back its approval of the Menaflex Collagen scaffold knee replacement device. The agency admitted that it approved the medical device without properly researching it because of political pressure and the flexible requirements that exist to fast-track certain devices. Under the 510(k) program, new medical devices can be approved quickly if their makers can show that the product works in the same that other medical devices currently in the market do.

In August, DePuy Orthopaedics recalled about 93,000 artificial hips over concerns that the medical devices had a 12 – 13% failure rate. Metal particles from the implants have also been known to cause cobalt toxicity.

Our Charlotte, North Carolina defective medical device lawyers know that it can be very upsetting to discover that you or your loved one developed health issues or now have to undergo yet another medical procedure because the manufacturer of your medical device was negligent.

Is the FDA doing its job?, Washington Post, November 3, 2010

Why the FDA can’t protect the public, BMJ, November 2010

FDA Determines Knee Device Should Not Have Been Cleared for Marketing, FDA, October 14, 2010

DePuy ASR Hip Replacement Products Recalled, North Carolina Injury Lawyer Blog, September 16, 2010

Related Web Resources:
US Food and Drug Administration

VNS Therapy, Cyberonics

DePuy Orthopaedics, Inc., a Johnson and Johnson unit, is recalling its ASR Hip Resurfacing Systems and ASR XL Acetabular Hip Replacement products. ASR Hip Resurfacing Systems is a partial hip replacement product, and ASR XL Acetabular Hip Replacement is a total hip replacement system. Some 93,000 patients around the world have been implanted with one of these medical devices.

The recall comes in the wake of information from the National Joint Registry (NJR) of England and Wales noting that within five years of the original hip replacement procedure involving one of these products, 1 in 8 patients had to undergo a second procedure known as revision surgery. Considering that many hip replacement patients tend to be older and may be suffering from other health issues, undergoing even one surgery can be tough and can result in complications. To have to undergo a second surgery can take an even greater toll on a patient’s health, as well as cause additional pain and suffering.

Although DePuy Orthopaedics has said that it will cover medical expenses, testing, and monitoring related to the recall, it is not known at this time what the company won’t be covering and whether patients will receive medical payments in a timely manner.

Your orthopedic surgeon can help you determine how well your ASR hip implant is working and whether you need to undergo a second surgery.

Signs of a possible problem with your ASR hip implant:

• Difficulty walking
• Pain when walking
• High level of microscopic metal particles around your hip (a blood test can help determine this)
• Dislocation of the implant
• Swelling

It is important that you contact the Law Offices of Michael A. DeMayo to find out if you have grounds for a North Carolina defective medical devices case.

Related Web Resources:
ASR™ Hip System Recall Guide, DePuy

DePuy Orthopaedics

National Joint Registry (NJR)

Michael A. DeMayo, a Charlotte, North Carolina personal injury lawyer, is now a member of the Multi-Million Dollar Advocates Forum, one of the most prestigious groups of trial lawyers in the country. Members must have won multi-million dollar verdicts, settlements, and awards for their clients. Attorney DeMayo, who is founder and president of the Law Offices of Michael A. DeMayo, is also a Life Member of the Million Dollar Advocates Forum. Less than 1% of US attorneys belong to this group, known for its excellence in advocacy and for having obtained for at least one client an award, settlement, or verdict of $1 million or greater.

Charlotte, Personal Injury Attorney DeMayo leads a team of dedicated professionals with over 100 years of combined legal experience. They are committed to obtaining the financial recovery that their clients and families are owed by negligent parties. Our North Carolina law firm represents victims and surviving family members with all types of injury cases, including those involving medical malpractice, automobile accidents, truck accidents, slip and fall, products liability, defective medical devices, dangerous drugs, nursing home neglect and abuse, motorcycle accidents, dog bites, pedestrian accidents, and workers’ compensation. The Law Offices of Michael DeMayo is located in Charlotte, Monroe, Hickory, and Lumberton, North Carolina. We also represent clients with South Carolina personal injury cases in the counties of Marlboro, Chesterfield, York and Lancaster.

Charlotte, North Carolina Car Accident Lawyer Michael A. DeMayo is also an active member of the community. Each year, his law firm awards college scholarships to a number of high school seniors for their innovative and creative ideas on ways to stop teens from driving drunk.

Multi-Million Dollar Advocates Forum & Million Dollar Advocates Forum

Michael A. DeMayo, Esq.

Verdicts & Settlements, Law Office of Michael A. DeMayo

According to a new study, more than 70,000 teenagers and children end up in the emergency room every year because of medical device complications. Other findings by the US Food and Drug Administration researchers:

• Approximately ¼ of the issues involve contact lenses use, which can lead to eye abrasions and infections.
• Hypodermic needles that break off in the skin is another common cause of medical-device-related child injuries.
• Ear tubes can cause infections.
• Illegal drug use involving hypodermic needles that break can also lead to injuries.
• Pelvic devices used to conduct gynecological exams on teenagers can cause skin tears.
• The most serious medical device-related issues involved chest catheters for cancer patient, implanted devices, and insulin pumps.

Two of the most common reasons for medical device-related to injuries to minors are misuse and malfunction. Also many medical devices used on kids were made for adults.

Our Charlotte, North Carolina defective medical devices attorneys want to remind you that you may be able to hold the manufacturer of a malfunctioning or a defective medical device liable for North Carolina products liability. Inadequate warnings or incomplete instructions can also be grounds for a case.

We know how horrible it can be to discover that the medical device your child is using is harming rather than helping him/her. In some cases, the medical professional that determined that your son or daughter should use the medical device must be held liable for North Carolina medical malpractice.

Medical Device Problems Hurt 70,000+ Kids Annually, NPR, July 26, 2010

Medical device problems hurt 70,000+ kids annually, BusinessWeek, July 26, 2010

Related Web Resources:
Injuries Among Children and Adolescents, CDC

Journal of Pediatrics

This month, The Law Offices of Michael A DeMayo participated in two community service events. The first event was Walk Like MADD, which is hosted by Mothers Against Drunk Driving. Charlotte Personal Injury Attorney Michael A DeMayo served as the honorary chair for the annual 5k walk, which took place on May 2. Proceeds from the walk will go toward helping drunk driving victims and fund programs to prevent underage drinking and drunk driving.

Over two dozen of the North Carolina injury law firm’s employees and their families took part in the event. Together, they helped raise over $2,500. Attorney DeMayo and his staff are familiar with the struggles that drunk driving accident victims and their families face. He and his law firm represent North Carolina and South Carolina clients that have been injured and those whose loved ones have died in drunk driving accidents in their pursuit to recover personal injury or wrongful death compensation from all negligent parties. Just last year, the National Highway Traffic Safety Administration reported that both states experienced the largest spike in DUI fatalities among all US states between 2006 and 2007.

This past Saturday, employees from the Charlotte branch of the Law Offices of Michael A DeMayo participated in another event, this one at a Habitat for Humanity house. They pulled up their sleeves and spent the morning hanging dry wall at the home, which is being built for a low-income family. The North Carolina personal injury law firm, which also has law offices in Monroe and Hickory, made a $15,000 donation to this worthwhile cause.

Attorney DeMayo praised Habitat for Humanity for helping so many people in the Charlotte community that are in need of affordable housing. He also touted the benefits that his employees reaped by volunteering for this “great, team building” experience.

The Law Offices of Michael A DeMayo, LLP also helps clients with injury or wrongful death cases involving medical malpractice, nursing home abuse or neglect, defective medical devices, products liability, dog bites, and workers’ compensation.

Related Web Resources:
Walk Like MADD, Charlotte, NC

Habitat for Humanity, Charlotte

NHTSA Ranks North Carolina and South Carolina as Two US States With Greatest Increase In DUI Deaths, North Carolina Injury Lawyer Blog, September 2, 2008

Johnson & Johnson is announcing the recall of two lots of Duragesic pain patches. The recall, by its PriCara Division, is being issued because tears in the patches could expose users to the product’s gel and may result in an overdose. The recalled patches were made by ALZA Corp.

Recalled lots include:

• Duragesic 50 mcg/hr patches, lot number 0817239
• Sandoz Inc 50 mcg/hr patches, lot number 0816851

J & J is conducting the recall with the Food and Drug Administration. This is not the first recall involving improperly sealed Duragesic pain patches. In February 2008, J & J recalled some 32 million Duragesic Pain Patches over similar concerns. In 2004, Janssen Pharmaceuticals Products recalled 75 patches over leakage concerns also.

In 2007, the Food and Drug Administration issued a warning that accidental overdoses have been associated with use of the pain patch. The FDA has received over 100 reports of deaths that may have been related to use of fentanyl pain patches.

Duragesic, also known as fentanyl, is an opioid pain reliever that is 100 times stronger than morphine. You are not supposed to use fentanyl if you have drug allergies or a history of mental illness, seizures, breathing problems, heart problems, drug or alcohol dependence, low blood pressure, depression, liver disease, kidney disease, a brain tumor, or a head injury. Direct skin exposure to the gel that is inside the patch can cause respiratory problems, nausea, drowsiness, sedation, serious health complications, or lead to fatal overdoses.

Direct Exposure to Duragesic’s Gel:
If you or anyone has come into direct contact with fentanyl gel, it is important that you wash the skin completely with water only. Do not use soap or rub the skin too much. Do not directly handle patches that are torn or have cut edges. Use gloves or tissue instead. You can also get rid of the patches by flushing them down the toilet.

Medical device makers and pharmaceutical drug manufacturers are supposed to make sure that their products are safe for consumer use and free from defects that can cause illness, injury, or death. If you or someone you love was injured by a defective or dangerous medical device, you may be able to file a products liability claim or lawsuit against the negligent manufacturer.

J&J Recalls Two Lots of Pain Patch, The Wall Street Journal, December 31, 2008

Duragesic Patch Recall Adds to Johnson & Johnson Patch Woes, News Inferno, February 13, 2008

Related Web Resources:

Duragesic

Johnson & Johnson

US Food and Drug Administration

The family of a man who died after he was implanted with a cardiac defibrillator is suing Boston Scientific for his wrongful death. They allege that the defibrillator was defective and caused his death. Boston Scientific used to be called Guidant Corp. Also named as defendants in the products liability lawsuit are Guidant Puerto Rico Corp. and Guidant Sales Corp.

Joseph Robert was implanted with an Implantable Cardioverter Defibrillator (ICD), a Medtronic InSync Sentry defibrillator with Guidant leads, on October 26, 2000. This device is designed to monitor the person’s heart and when there is rapid, abnormal heart rhythm, the ICD is supposed to send energy to the heart muscle so that the heart can beat at a normal rate again.

In 2005, Roberts was admitted to a hospital for an ICD upgrade to a Vitality 2 biventricular automatic implantable cardioverter-defibrillator. His original ICD was being replaced because it had been found defective and dangerous. Roberts died nearly three weeks after the second device was implanted.

Patsy Roberts, one of the plaintiffs in this products liability wrongful death case, says that in 2007, she found out that Boston Scientific recalled the Vitality 2 because it was considered dangerous and defective also.

The plaintiffs claim that the defendants were grossly negligent and engaged in fraud, misrepresentation, breach of express warranties, breach of continuing duty to warn, breach of implied warrant of fitness, and breach of warrant of merchantability. They also say that the defendants violated the Texas Deceptive Trade Practices-Consumer Protection Act.

They are asking for damages for Joseph’s pain, suffering, and mental trauma before he died, as well as for their own pain and suffering, loss of consortium, loss of affection, grief, and other associated costs.

In North Carolina and South Carolina, our defective medical device lawyers have represented victims and their families whose lives have been catastrophically affected by a defective Guidant cardiac defibrillator. We believe that manufacturers of defective medical devices and the other liable parties should be held financially liable for your pain, suffering, and associated costs.

Wrongful death suit filed against Boston Scientific over cardiac defibrillator, Southeast Texas Record, April 21, 2008

Sudden Cardiac Deaths, Get the Facts 2006, AmericanHeart.org

Related Web Resources:

Boston Scientific

FDA: Some Guidant Defibrillators Recalled, WebMD, June 17, 2005

Now, more than ever, it is important to speak with an experienced defective medical device attorney to discuss your case. In an 8-1 vote today, the U.S. Supreme Court voted to place new limits on defective medical device lawsuits filed against Medtronic Inc. and other medical device manufacturers: Patients cannot sue a medical manufacturer if the product that caused the injury was cleared by a strict federal review process.

In this latest case, the Supreme Court barred a lawsuit filed by the widow of a man who was permanently injured when his Medtronic heart catheter burst while he underwent angioplasty surgery. The Medtronic product had been gone through the U.S. Food and Drug Administration’s pre-market approval process. When the device burst, the patient developed a complete blockage and had to undergo emergency bypass surgery. He died three years ago.

The Bush administration and medical device manufacturers had both argued in favor of precluding state law claims with the more rigorous pre-market review process.

This new ruling could work in favor of medical devices makers that have been named as defendants in the thousands of defective products lawsuits that are still pending. It could also work in favor of drug manufacturers. Drug makers are also trying to get the U.S. Supreme Court to place limits on lawsuits filed by people injured from taking a dangerous or defective drug.

Lawsuits that will be most impacted by the ruling are cases involving medical devices that have undergone the FDA’s yearlong pre-market approval process. This is an arduous process, which is why only 43 new applications were filed in 2005. A fast-track review is available to new devices that are similar to products that are already being sold in the marketplace.

The Supreme Court’s ruling does leave room for defective medical device lawsuits filed under state rules that are considered parallel to federal requirements.

Our North Carolina and South Carolina defective products law firm has helped many injured patients and their families recover compensation from medical device makers and drug manufacturers. We have the experience and resources to help you explore your options and take the necessary and available steps to pursue your case.

Patient Medical-Device Suits Curbed by Top U.S. Court, Bloomberg.com, February 20, 2008

Justices Make It Tougher to Sue Medical Device Makers, The New York Times, February 20, 2008

Related Web Resources:

Read the Supreme Court Decision, Justia & Oyez

Medtronic, Inc.

Medical device manufacturer Medtronic wants the U.S. Supreme Court to rule that medical device makers are exempt from products liability lawsuits, if a device that caused the injury is FDA approved.

The specific case, Riegel v. Medtronic, stems from a personal injury lawsuit filed by the family of Charles Riegel, a man whose Medtronic-manufactured balloon catheter burst while he was undergoing a medical procedure to clear his arteries.

In the lawsuit against Medtronics, Riegel cited negligent design and labeling and manufacturing issues. The catheter was FDA approved. The lawsuit was thrown out at both the U.S. District Court level and the US Court of Appeals level before arriving at the Supreme Court.

Medtronics claims that amendments to the Food, Drug, and Cosmetic Act say that FDA-approved medical devices are preempted from product liability lawsuits in state civil courts. The amendments, however, do not say that federal standards are preempted by state common law claims. This, however, is what Medtronics is claiming and the Bush Administration supports with the device maker’s assertion.

If the Supreme Court decides that Medtronics is right, anyone injured by a defective medical device won’t be able to file a personal injury claim or lawsuit.

Last December, Medtronics agreed to pay $114 million to settle 2,682 products liability lawsuits by people who had used the company’s Marquis implanted cardiac defibrillators. A battery problem had caused some of the defibrillators, implanted in patients at risk of heart attacks, to fail. ICD’s had to be surgically replaced in 11,000 patients.

Last year, Medtronic announced an international recall of heart-defibrillator wires, which were fracturing at a rapid rate. Some 235,000 people have these wires implanted in their chests.

If you have been injured or suffered health problems or have had to undergo a medical procedure because of a defective medical device, you should contact our North Carolina or South Carolina products liability law firm immediately.

Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices, NewsInferno, January 3, 2008

Medtronic to Pay $114 Million In Settling Heart-Device Suits, The Wall Street Journal, December 21, 2007

Related Web Resources:

Riegel v. Medtronic, Supreme Court Docket

Medtronic