Transvaginal Mesh Failure
As reported from Nurenberg Paris
Many women who suffer pelvic organ prolapse (POP) or stress urinary incontinence (SUI), medical conditions that occur when the internal support structure of the vagina fails, undergo a surgical procedure in which a transvaginal mesh (TVM) is inserted to help hold the woman's internal organs in place. Rather than simply stitching tissue of the vaginal wall together, the transvaginal mesh is used to keep the organs - namely the urethra, cervix, and rectum - from falling out of place and "sagging" inside the body cavity.
In 2010, more than 75,000 women had transvaginal mesh surgery to repair pelvic organ prolapse.
Transvaginal Mesh Complications
A recent study regarding vaginal meshes published in the New England Journal of Medicine revealed troubling results with these procedures: women who had a transvaginal mesh inserted suffered higher rates of serious complications, including bladder perforation and pelvic hemorrhage and an increased number of adverse events after the surgery, such as urinary incontinence and pain during intercourse.
The U.S. Food and Drug Administration (FDA) warns, "The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain."
Furthermore, these problems can result in additional complications, such as the need for a second, "revision surgery," IV therapy, blood transfusions, and the treatment of hematomas or abscesses.
Update: The FDA issued an urgent safety communication advising patients and their healthcare providers to consider alternatives to transvaginal mesh. The FDA met to discuss a potential ban on the mesh, after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.
Is pelvic organ prolapse common?
Some estimates suggest that nearly half of all women between the ages of 50 and 79 have some degree of prolapse. The risk that a woman will need a surgical procedure to correct prolapse is about 11%, and about 33% of these women will need a second surgery to correct problems stemming from the condition or initial surgery.
What causes this condition?
Pelvic organ prolapse is a result of predisposition, race, and injury. Caucasian women are more likely to suffer the condition than African American women, and injury, childbirth, heavy lifting, and even smoking are also contributing factors.
What should I do if I had a problem with a transvaginal mesh?
If you or someone you care about has a transvaginal mesh used to correct pelvic organ prolapse and suffered any of the above symptoms, our law firm may be able to help. Contact us today to learn how.
The Implants Loophole
By BARRY MEIER
Published: December 16, 2010
A recently recalled artificial hip made by a unit of Johnson & Johnson, designed to last 15 years or more, is failing worldwide at unusually high rates after just a few years. One of the most troubled orthopedic implants of the past decade, this artificial hip — known as the A.S.R., or Articular Surface Replacement — was originally promoted as a breakthrough in design that would last longer and provide patients more natural movement.
But many patients soon developed inexplicable pain, and surgeons, when replacing the implant, discovered mysterious masses of dead tissue near the thighs of some patients.
Until late summer, officials at the Johnson & Johnson unit, DePuy Orthopaedics, the largest maker of replacement hips worldwide, maintained that the A.S.R. was performing on a par with competing devices. But interviews with doctors indicate that DePuy received repeated warnings that the implant was failing and that surgeons were abandoning it.
The brief and troubled life of DePuy’s A.S.R. hip points to a medical implant system that is piecemeal and broken on many fronts, critics say. Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. click here for the full story.
Johnson & Johnson DePuy ASR Hip Implant Recall Sparks Lawsuits
By NewsInferno – September 8th, 2010
Several lawsuits have already been filed over the Johnson & Johnson DePuy ASR hip implant. Last month, Johnson & Johnson issued a worldwide recall for the ASR XL Acetabular System and the ASR Hip Resurfacing System following complaints of device failure.
Johnson & Johnson announced the recall of the DePuy ASR Hip Implant system after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received one of the recalled devices had to undergo revision surgery within five years of receiving it. The recall involved the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur. Only the ASR XL Acetabular System was approved for use in the United States.
At least 93,000 people around the world have received one of the recalled Johnson & Johnson DePuy ASR hip implants.
According to a Bloomberg News report, lawsuits over the Johnson & Johnson DePuy ASR hip implant have been filed in federal courts in San Francisco and New Jersey, and in a state court in California. The San Francisco lawsuit was filed by a construction worker who received two implants in 2007. The plaintiff, 52-year-old Maurice Brigham, suffered “pain, swelling inflammation, infection and damage to surrounding bone and tissue” due to defects with the hip- replacement mechanisms, the suit claims. Brigham had one of the devices removed last month, but hasn’t been able to get a replacement and is now unable to walk, the suit said.
Brigham’s suit charges that Johnson & Johnson’s DePuy Orthopaedics unit knew for years many of the 93,000 patients with ASR hip implants required corrective surgeries because of the products’ defects, Bloomberg said. According to Bloomberg, a lawsuit in federal court in Newark, New Jersey also claims that DePuy was “fully aware” that the hip implant was defective, having received more than 300 reports of ASR hip failures.
Finally, a lawsuit filed in state court in Los Angeles contends that the plaintiff’s body rejected an Johnson & Johnson DePuy ASR hip implant because of a design flaw that allows metal to grind on metal within the mechanism, Bloomberg said. One New York plaintiffs’ attorney told Bloomberg that it’s likely more lawsuits involving the Johnson & Johnson DePuy ASR hip implant will be filed in the coming months.
J&J warned for illegal product sales
By The Associated Press (AP) – Aug 24, 2010
The Food and Drug Administration says Johnson & Johnson is selling a hip implant for unapproved uses and marketing an unapproved, high-tech system to guide doctors in implanting knee replacements. This news comes just a day after J&J's ninth product recall in a year the FDA issued another warning involving foul-smelling drug packages, contamination with tiny metal shards or bacteria, and drugs that might have the wrong amount of active ingredient.
At Medtronic, a Profit Goal for Training By BARRY MEIER
Published: September 10, 2009
Producers of medical devices — hardware like heart pacemakers and artificial hips — have long insisted that their financial contributions to teaching hospitals are meant to educate doctors, not to develop new customers for their products. But recently disclosed internal marketing documents of Medtronic seem to suggest otherwise.
The documents, a set of slides with revenue projections, calculate how much the company could expect to get back by paying for training fellowships for doctors. It is a return on investment any corporation would envy: 200 percent. The internal marketing presentation, disclosed by an Australian newspaper, The Age, was produced in 2007 by a Medtronic division in that country that sells devices for spinal surgery. The presentation briefly describes a “Global Fellowship Program” under which Medtronic would spend $1.5 million over three years to underwrite 18 fellowships in Australia and elsewhere. >full story
BOSTON — Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous. Dr. Laurence M. Epstein, a surgeon at Brigham and Women’s Hospital in Boston, specializes in extracting defibrillator cables made by Medtronic.
Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died. But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country. Click here for the full story.
On the same day last month that a federal judge in St. Paul threw out hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of those flawed products surgically removed. A slender electrical cable, or lead, connects an implanted defibrillator to a patient’s heart.
The risky operation went terribly wrong. As doctors extracted the device, a thin electronic cable, from the patient’s heart, a vessel was punctured, causing extensive bleeding. The 33-year-old patient, Mark Turnidge, died two days later, leaving behind a wife and two young sons.
“They told me he had suffered massive brain damage,” said his wife, Wendy Turnidge. Click here for the full story.
A widely used heart device recalled two years ago by Medtronic may be failing in patients at a rate significantly higher than previously known, a new report by two prominent cardiac specialists indicated.
The Medtronic device, known as the Sprint Fidelis lead, is an electrical cable that connects an implanted defibrillator to a patient’s heart. The study also indicated that the component’s failure rate might be increasing over time, a potentially troubling development for patient care. More than 235,000 people received the Sprint Fidelis leads before they were recalled, and many of those patients still have them in place. The device’s flaw, which made it prone to fracturing, caused some defibrillators to deliver unnecessary shocks to a patient’s heart or to not fire when needed to send a life-saving jolt. Click here for the full story.
Intra-Articular Shoulder Pain Management Pumps Linked with Injury A new study published in the American Journal of Sports Medicine has linked a number of commonly used intra-articular shoulder pain management pumps with serious cartilage damage. The results were presented at the 2008 meeting of the American Orthopedic Society for Sports Medicine.
The study incorporated a review of 177 patients who underwent arthroscopic shoulder surgery and found a higher incidence of cartilage damage in those who received an intra-articular pain management pump. The pain management pumps are surgically implanted to serve as a delivery system for pain medication following arthroscopic surgery.
Post Arthroscopic Glenohumeral Chondrolysis
Post arthroscopic glenohumeral chondrolysis (PAGCL) is an extremely painful medical condition characterized by postoperative deterioration of cartilage in the shoulder. Intra-articular shoulder pain management pumps deliver controlled doses of medication to the joint following arthroscopic surgery. Ironically, the pump may actually cause significantly more pain than that which it is designed to alleviate.
PAGCL is a debilitating condition because of its effect on the joints. Without cartilage, joints are not protected from friction, causing extreme pain and limited mobility. Currently, there are not a lot of options available for the treatment of cartilage deterioration like that associated with PAGCL.
PAGCL Symptoms
There are a number of common symptoms associated with the development of PAGCL that can be indicative of development of the painful condition. Some of the more common PAGCL symptoms include:
* Chronic shoulder pain
* Shoulder weakness
* Popping, clicking or grinding of the shoulder
* Shoulder stiffness
* Limited range of shoulder motion
If you have been implanted with an intra-articular shoulder pain management pump and begin to experience any of the aforementioned symptoms, you may have developed PAGCL. Symptoms typically develop between three and five months after surgery. However, it is not uncommon for symptoms to take as many as 12 months to fully develop.
Intra-Articular Pumps Linked with PAGCL
A number of commonly used intra-articulator shoulder pain management pumps have been linked with the development of PAGCL, including:
* Stryker PainPump
* Stryker PainPump Blockaid
* BREG Pain Care Infusion Pump
* Donjoy Pain Control Device
* Donjoy Accufuser Plus Pain Pump
* I-Flow On-Q PainBuster
Patients who have been treated with one of the aforementioned pumps should consult with their physician immediately to determine the best course of action.
Shoulder Pain Pump Lawsuits If you or a loved one has been injured as a result of a defective shoulder pain pump, you may be entitled to receive compensation. Medical device manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them to the public. Failure to adequately measure the effectiveness of a given product or inform physicians and consumers about any potential problems is considered negligent and may be grounds for personal injury litigation.
