Dangerous Devices

 Only five years after announcing a $4,400,000,000 settlement to resolve lawsuits involving defective knee and hip replacement systems, DePuy – a subsidiary of Johnson & Johnson - is now facing additional lawsuits over their most recent knee replacement system, the DePuy Attune.

Marketed on release as the most costly and research-intensive medical device in DePuy’s development history, the Attune Knee System has since exhibited questionable results in terms of both the safety and effectiveness of the device. In recent months, dozens of adverse event reports by clinicians and DePuy have been filed with the Food and Drug Administration’s Medical Device Adverse Event Reporting Database. Moreover, a recently published study in the Journal of Knee Surgery noted an unusually-high rate of revisions due to premature failures of the Attune Knee System. The authors further attributed the failures to design features inherent in the device, namely that the tibial portion of the system fails to adequately integrate into the tibial surface of the bone. As a result, the device becomes destabilized and/or loosened, and typically will require additional surgery to resolve.

Thousands of patients have been implanted with the Attune Knee System to date. Symptoms associated with these premature failures include:

• Loosening of the device
• Decreased range of movement
• Infection
• Bone loss
• Swelling
• Persistent pain
• Instability of the device
• Surgery to remove and/or replace the device

If you or a loved one have a DePuy Attune Knee System, please contact Daniel P. Kondos today.

IVC filters are small metal devices inserted into the inferior vena cava via access to the jugular or femoral vein. The umbrella-like filter shape allows the device to catch clots traveling through the bloodstream before they can reach vulnerable organs, preventing complications such as pulmonary embolism. The filters are typically used when blood-thinners are contraindicated, and come in two types: permanent and retrievable. To date, the focus of IVC filter litigation has primarily revolved around the poor design and inadequate safety and efficacy profile of the retrievable filter models.

The Controversy

In August 2010, the FDA issued a warning to doctors, alerting them about the risk of adverse events with retrievable IVC filters, such as those manufactured by Cook, Cordis and C.R. Bard. The agency indicated that the filters should be removed in many cases once the danger of a pulmonary embolism has passed.

At least 900 adverse event reports have been received by the FDA involving complications from IVC filters. One of the most common complaints is of the filter, or a piece of the filter, breaking off and migrating through the patient’s body. Perforation and tilting of the device has also been reported, and in many cases result in the inability to retrieve the device safely.

In May 2014, the FDA issued an updated safety statement indicating that patients may face an increased risk of problems with IVC filters the longer they remain in place, advising doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.

In April 2015, a study published in the Journal of the American Medical Association (JAMA) found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism. The researchers found that filter recipients were twice as likely to have a blood clot travel to their lungs than those on blood thinners.

A study published in August 2015 in a letter in JAMA warned that the long-term risks of IVC filters may negate any health benefits they provide in catching blood clots.

The FDA issued a warning letter to Bard in July 2015 for illegally marketing a device used to remove IVC filters, failing to report adverse events, failing to cooperate with the FDA, as well as highlighting problems with its Denali IVC filter.

Finally, in August 2015, NBC Nightly News aired a two-part special on the Bard Recovery IVC filter, one of the first retrievable devices on the market. In their report, NBC detailed failures in reporting known adverse events (including deaths), suppression of internal-data exhibiting how dangerous the devices are compared to competitors, and that FDA clearance was based on a forged document.

Injuries

• IVC filter migration
• IVC filter fracture
• IVC filter perforation
• Tilting of the IVC filter
• The inability to retrieve the IVC filter
• Pulmonary embolism
• Compromised respiration
• Stroke
• Death

If you or a loved one suffered from symtoms or other serious complication that might be tied to IVC Filter, please contact 

Daniel P. Kondos today. 

 Mirena injuries can be extremely painful, and may impact the lives of victims and their families for years or more. Mirena's complications may include uterine perforation, pelvic inflammatory disease, ovarian cysts, irregular bleeding, and amenorrhea. Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility can even be put at risk.

Mirena Deception

The Mirena IUD was originally approved as an intrauterine contraceptive, and later as a treatment for heavy menstrual bleeding in women who gave birth. It works by slowly releasing the chemical progesterone levonorgestrel into the uterus. Mirena is indicated for intrauterine contraception for up to 5 years. At that point, the system should be replaced if continued contraception is desired. Mirena is only recommended for women who have had at least one child.

Bayer has marketed Mirena as a way "busy moms" can simplify their lifestyle. One of the ways it did so was through "Mirena Parties." Working with the social networking site Mom Central, Bayer had created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. The program was presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner. The script followed by the nurse practitioner at one of these Mirena Parties included phrases like "look and feel great", "simple ways to reconnect with ourselves and our partners," and "more likely to be more intimate.

According to an FDA Warning letter issued to Bayer in December 2009, the claims made in the script "clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena.

The letter went on to say that the FDA was "not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great." The agency also said the script omitted certain information regarding the risks of using Mirena, and minimized risks by utilizing the statement look and feel great." Finally, the FDA faulted the script for including a statement that Mirena “has no daily, weekly, or monthly routines to comply with," which the agency said was false.

Bayer stopped holding Mirena Parties in early 2009. But because of such misleading information presented at these events, many women who chose Mirena for its purported convenience may not have been aware of its many serious side effects.

Mirena Side Effects

Since its approval, serious Mirena side effects have included ectopic pregnancy, intrauterine pregnancy (a pregnancy in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.

• Breast Cancer
• Endometrial Cancer
• Uterine Cancer
• Ovarian Cancer
• Thyroid Cancer
• Colon Cancer
• Gastric Cancer
• Cervix Cancer
• Prostate Cancer
• Pre-Cancerous Cells
• Rectal Cancer
• Anal Cancer
• Bladder Cancer
• Birth Defects

If you or a loved one suffered from a uterine perforation, ectopic pregnancy, infection or other serious complication that might be tied to Mirena, please contact 

Daniel P. Kondos today.

Transvaginal slings and meshes are medical devices used to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both SUI and POP occur with advancing age, child birth, and pregnancy; and both are associated with weakened musculature in the pelvic region, resulting in an inability to properly support internal organs. As a result, symptoms arise such as the inability to properly control bladder function, pain, discomfort, and the extrusion of internal organs into and/or from the vaginal entrance. The lifetime risk of undergoing an operation to treat POP or SUI by the age of 80 is estimated to be around 11.8%, and currently there are over 200,000 surgeries performed annually for POP.

Manufacturers pushed for the development of transvaginal mesh in part as a response to the low success rate of traditional surgical treatments for POP and SUI known as colpopexy, or colporrhaphy. These surgical techniques involve surgically cutting and stitching areas of weakened connective tissues. Success rates for these standard surgical treatments are low, and typically require revision and/or additional surgery on the same area in about 40% of cases. As a result, device manufactures looked to other areas of medicine for potential devices capable of treating POP and SUI, ultimately settling on synthetic and biological meshes which had exhibited success in treating, among other complications, hernias. Unfortunately for many patients, the FDA has recently stated that it is no longer “clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The Controversy

Transvaginal mesh was approved for use by the FDA based on the 510(k) approval process, which requires a showing of substantial similarity to previously approved devices. As such, the FDA required little to no safety testing for the approval and marketing of transvaginal mesh. Manufacturers have lauded the use of transvaginal mesh as an alternative method of treating POP and SUI using a minimally invasive procedure, without the need of trimming the vagina or suturing mesh to the vagina. While methodology using transvaginal mesh has exhibited a higher success rate (i.e. a lower failure rate) compared to colpopexy and colporrhaphy, failure rates are still relatively high. For example, researchers report the need for additional surgery as upwards of 30%, depending on the device, procedure, and affected anatomical area.

Of greater concern than the rate of failure is the introduction of adverse events specific only to the use of transvaginal mesh. For example, in 2005, researchers out of Germany and Switzerland reported over 15% of patients experience mesh erosion and exposure. In 2006, Mentor Corp. became the first manufacturer to pull a vaginal sling device, OBTape, from the market. Specifically, after only three years on the market, it was apparent the device was defective as it failed to account for the necessity of allowing nutrients and oxygen to flow through the device and into the woman. Due to these complications and others, the FDA issued a bulletin in 2008 warning surgeons and patients of potential safety concerns, based on both published findings, and over 1,000 adverse events reported to the FDA’s adverse event reporting system between 2005-2007.

On July 13 2011, the FDA issued a follow-up to their 2008 warning intended to further underscore the risks of transvaginal mesh. Specifically, the FDA is now reporting that adverse events previously denoted as being rare, are now being recognized as not rare. For example, between 2008-2010, an additional 2,874 adverse event reports were submitted to the FDA. Of the adverse events, the most common and consistent complication was erosion, which often requires multiple surgeries to repair, can be debilitating in some women, and in some cases, further surgery fails to correct the initial problem. Finally, erosion can result in additional problems for male partners who may experience irritation and pain to the penis during intercourse due to mesh exposure.

In addition to erosion, the FDA warns of additional complications. For instance, mesh contraction (shrinkage) is now known as a predominant complication often associated with severe pelvic pain, pain during intercourse, and/or an inability to engage in intercourse. Additionally, the FDA and independent research has exhibited perforation of the bladder, blood vessels, and/or bowels occurs in around 3.5% of surgeries. Finally, the complications such as infection, pain, bleeding, pain during intercourse (dyspareunia), urinary problems, recurrent prolapse, vaginal scarring/shrinkage, neuro-muscular problems, and emotional problems have all been observed.

As transvaginal mesh was approved by the FDA with little to no safety testing, only requiring a showing of substantial similarity to previously approved products, little is known about the long-term safety and effectiveness of these devices. As a result, many surgeons and medical experts have gone on record in their respective peer-reviewed journals to state that these devices should be treated as experimental, and that informed consent (i.e. giving the patient all material information about the products risks and benefits) is impossible given the lack of medical evidence regarding the “risks, benefits, and overall safety and efficacy…sufficient to regard them as established medical practice.” Still other researchers have gone even further, suggesting that “until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials.” In response, the FDA Obstetrics-Gynecology Devices Panel will convene in early September 2011 to discuss and make recommendations regarding the safety and effectiveness of these devices.

Complications and Symptoms

• Mesh erosion and exposure through the vaginal wall
• Pain
• Urinary problems
• Recurrence of prolapse
• Recurrence of incontinence
• Infection
• Pain during sexual intercourse
• Inability to engage in intercourse
• Vaginal scarring and/or shrinkage
• Bladder, bowel, or blood vessel perforation

• Johnson & Johnson®
  • Ethicon® TVT
  • Gynecare® TVT
  • Gynecare® Prosima
  • Gynecare® Prolift
  • Gynemesh® PS
• Boston Scientific®
  • Advantage™ Sling System
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Arise®
  • Lynx®
  • Pinnacle®
  • Solyx®
• C.R. Bard
  • Avaulta Plus™ Biosynthetic Support
  • Avaulta Solo™ Synthetic Support
  • Faslata™ Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • Avaulta Plus™ Biosynthetic Support
  • Avaulta Solo™ Synthetic Support
  • Faslata™ Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
• American Medical Systems
  • Sparc®
  • MiniArc®
  • Monarc®
  • In-Fast®
  • BioArc®
  • Elevate®
  • Perigree®
  • Apogee®

If you or a loved one have suffered If you or a loved one have suffered from any side effects from transvaginal mesh please contact Daniel P. Kondos today.

 Designed by Johnson and Johnson’s subsidiary, the ASR total hip replacement device was released in 2005 after obtaining 510k clearances from the FDA. Such clearance allowed the manufacturer to enter the market without first evaluating the safety and effectiveness of the device on the basis of ‘substantial similarity’ to previously cleared devices.

The purported advantage of the device was two-fold. First, the device used a chromium-cobalt alloy, hypothesized to reduce wear damage and consequently last longer. Second, instead of using traditional adhesive cement, or screws to bind the device to the skeleton, the ASR is covered in a porous metal coating, facilitating natural adhesion via bone growth into the pores. Since its release, 93,000 devices have been installed worldwide.

The Controversy

Since 2005, the ASR device has suffered multiple blows from academic, medical, and government reports; ultimately resulting in DePuy recalling the device in July of 2010[1]. The magnitude of such a catastrophic failure is strongly evidenced by Johnson and Johnson’s most recent financial statement indicating the company had set aside $992 million dollars in anticipation of litigation[2]. These funds will be used to litigate, and settle, claims arising from both the defective nature of the device, as well as potential heavy metal poisoning.

Evidence of the substandard nature of the ASR device began to surface in 2008, with reports by both the FDA and the British HMRA (the British equivalent to the FDA). In their report, the MHRA detailed evidence of ‘genetic damage in patients with certain metal hip implants,’ including those with the same components as the ASR. In addition, the report cites the potential for systemic immunotoxic effects, local immune effects, and increased levels of metal in serum [3]. In the same year, the FDA reported over 400 complaints from or about patients with the ASR device. Thirteen percent of patients with the ASR device required a second surgery to replace the defective device[4].

A year later, the Australian Joint Registry investigated metal on metal bearings, concluding that both the Zimmer Durom, and the DePuy ASR exhibited higher than average revision rates. Specifically, the authors pointed out that 41% of the devices exhibited loosening, while noting a pattern of extensive wear markings, corrosion, and some carbide precipitation (which can affect wear and mechanical performance)[5].

Subsequent reports support the conclusion that the ASR is an inferior device. Difficulty installing the device, as well as getting it to adhere to the body, have resulted in unreported data from the UK and Wales Joint registry, suggesting a failure rate requiring revision between 11-13%[6]. There have also been subsequent studies pointing to the danger of having heavy metal particles, which enter the bloodstream after separating from the device during movement, accumulating in the body. Specifically, clinical research has shown that a small percentage of patients with a metal-on-metal device similar to the ASR exhibited adverse reactions to metal debris, requiring revision. These patients further exhibited higher blood levels of Cr and Co ions than asymptomatic patients[7]. Genotoxicity, which can alter the structure or integrity of genetic material in an organism, has also been reported by the British Committee on the Safety of Devices[8]. The danger of this form of toxicity is that it can result in cancer, or if the damage occurs in reproductive cells, inherited disorders in offspring. Finally, as these metal ions are excreted through the kidneys, internal damage can be exacerbated in those with renal failure, or those at risk of renal failure.

Symptoms

• Unexplained hip pain
• Difficulty standing or walking
• Loss of mobility
• Intense lift-off pain, noted as the most common symptom
• Behavioral effects associated with heavy metal poisoning

If you or a loved one have a DePuy hip implant, please contact 

Daniel P. Kondos today. 

The Zimmer Nex-Gen Flex Knee Replacement is a medical device used to cap the femur and tibia at the knee. Unlike the more common implanting method, which requires using a traditional adhesive cement to bond thigh bone and implant, the Zimmer device was designed with a porous fiber metal coating facilitating attachment via natural bone growth into the device. The postulated advantage of such a design is greater longevity of the device by circumventing the issue of cement, and its propensity to break down over time.

Since the release of the device in 2003, Zimmer has reported sales of over 150,000 of the devices. In 2009, these sales represented 2% of their $1.76 billion in sales.

The Controversy

While the device continues to remain on the market, questions about its safety and effectiveness have begun to surface. In 2010, a former Zimmer consultant and orthopedic surgeon at Rush University Medical Institute delivered a presentation to the American Academy of Orthopedic Surgeons, detailing his disturbing findings about the effectiveness of the device. Their data revealed that one year post surgery, 9% of patients required revision surgery, while another 36% demonstrated signs of loosening indicating potential impending failure. Furthermore these patients reported an uncommon level of pain relating to the new knee. Not surprisingly, the authors concluded their report by stating, “This component is still commercially available but should not be used for any patient.”

Since the report by Dr. Berger, a multitude of supporting research has been published echoing concerns that the device is inherently unsafe. These reports have included studies done in Korea as well as the United States.

Symptoms

Symptoms of a defective Zimmer Nex-Gen CR Flex Knee replacement include

• Loosening of replacement knees
• Unexplained pain after knee replacement
• Knee stiffness, or constant pain in the knee
• Limping
• Trouble placing weight on the knee
• Diminished joint movement

As a result of these defects, many devices may require revision surgery to correct complications associated with looseness and device migration. Others may require replacing the device with a more effective and reliable model.

Contact Us

If you believe you or a loved one have a defective knee implant, please contact Daniel P. Kondos today.

 Since entering the market in 2006, the Zimmer Durom Cup has been implanted in over 13,000 patients nationwide, and was initially heralded as a major advancement in total hip replacement surgery. Specifically, the Durom Cup was designed with the intention of creating a device that would last longer, as well as fuse to the skeleton naturally as opposed to requiring screws. To achieve these ends, the ace tubular shell was coated with a porous material, allowing natural bone growth to occur into and within the shell, the result being a natural fusion between device and skeleton.

The Controversy

Since the release of the device, its safety and effectiveness have come into question based on data suggesting excessive failure rates, the suspension and eventual termination of sales, and lawsuits against Zimmer by both patients and shareholders. In 2008, Zimmer reported setting aside $69 million in anticipation of litigation.

In April 2008, Dr. Lawrence Dorr, a former consultant for Zimmer as well as an orthopedic surgeon with over 30 years experience, released the first adverse report detailing unacceptable failure rates associated with the device. Specifically, one year after implanting the device, 15% of patients required revision. Among the remaining population, an even greater number of patients exhibited signs of impending failure. According to the New York Times, Dr. Dorr disclosed this data with Zimmer but the company declined to take action until the results were made public by the American Association of Hip and Knee Surgeons. In July 2008, Zimmer pulled the device from the market temporarily, and ultimately discontinued sales in 2010.

While Zimmer initially indicated in a follow-up study of their own design that up to 5.7% of implants would need to be replaced in the US and Europe, alternative investigations have suggested a higher rate of failure. The most recent study, conducted at the University of Wisconsin, compared outcomes following total hip replacement using two different devices one year after surgery. The data collected by the authors indicated that while none of the more modern alternative devices failed, the Durom Cup exhibited a striking 11% failure rate. Furthermore, patients with the failed device exhibited pain and discomfort indistinct from pre-operation levels.

In both the Wisconsin and Dr. Dorr studies, closer inspection of the failed device revealed an absence of proper fusion between cup and bone, suggesting design flaws. Consequently, the device can separate and migrate, pushing the metal hip socket against the bone to produce excruciating pain. As a result, the patient may require surgery, rehabilitation, and in-patient hospital monitoring.

Finally, recent evidence suggests that the metal-on-metal design of the device can lead to arthroprosthetic cobaltism, resulting in genotoxity and the potential for changes in the structure or integrity of genetic material in an organism. The danger of this form of toxicity is that it can result in cancer, or if the damage occurs in reproductive cells, inherited disorders in offspring. Finally, as these metal ions are excreted through the kidneys, internal damage can be exacerbated in those with renal failure, or who are at risk of renal failure.

Symptoms

• Start up stiffness and pain when rising from a chair or getting out of a car after three months 
  post-operation
• Sharp groin pains when moving from bent to upright positions or when lifting the leg straight up
  when lying down
• Difficulty climbing stairs
• Inability to walk distances
• Reliance on a cane when walking outdoors
• Behavioral effects associated with heavy metal poisoning

If you or a loved one have or had a Zimmer hip implant and have been diagnosed with any of the above, please contact Daniel P. Kondos today. 

Medtronic’s InFUSE bone graft system is both groundbreaking and unique in many aspects. The FDA approved InFUSE/LT-CAGE in 2002 as a combination device comprised of InFUSE, a collagen sponge used as a carrier for InFUSE, and a spinal cage called the LT-CAGE to hold all three components together1. While the cage and collagen matrix don’t necessarily represent a groundbreaking discovery, the development of InFUSE changed the landscape of spinal surgery.

Arguably more accurately described as a new drug or even biologic, InFUSE is a recombinant human bone morphogenetic protein (rhBMP-2) which stimulates new bone growth by mimicking a protein naturally produced by the human body. To put this in perspective, most, if not all, previous spinal fusions required either harvesting the patient’s own iliac crest bone or the use of cadaver grafts, in order to gather enough BMP to stimulate bone growth and achieve spinal fusion. As both autologous and cadaver bone grafts have their own inherent drawbacks, such as graft rejection or pain at the site of harvesting, Medtronic found themselves in a wide open market once the system was approved by the FDA. Unfortunately for Medtronic, the FDA also implemented a number of very stringent controls on the use and marketing of InFUSE.

The Controversy

Since FDA approval of InFUSE, Medtronic has captured the majority share of the spinal fusion market, and has realized billions in profit from sales. However, while some of their sales are certainly a result of developing a new, groundbreaking treatment, recent findings show much more was at work driving those sales.

Perhaps the most egregious actions undertaken by Medtronic are allegations, and findings, that Medtronic not only sponsored many of the studies touting InFUSE for both on- and off-label procedures, but also wrote and published the studies and paid the authors tens of millions of dollars in return. Worse yet, when these studies were critically reviewed by The Spine Jounal, which dedicated an entire issue to the topic, unbelievable ethical violations came to light. For example, in 13 studies funded by Medtronic, encompassing over 700 patients, not a single adverse event was reported. In one study at Walter Reed Army Medical Center, the author simply made up data. In another, adverse events previously reported to the FDA during the approval process disappeared when published in a scientific journal. In yet another, Medtronic authored an article and purposefully excluded adverse event data. With such glowing reviews permeating the literature, it’s no wonder surgeons throughout the country began using InFUSE in off-label procedures. These surgeons were denied the full story.

By reporting perfect or near perfect safety, the original studies might have led others to widespread off-label use of the product with some potentially catastrophic outcomes. Revised estimates of adverse events are:

1. Posterior lumbar interbody fusion techniques: 25-50% risk of associated adverse events.
2. Anterior lumbar interbody fusion: 10-15% risk of adverse events.
3. Anterior cervical fusion: 40% greater risk of adverse events in the acute postoperative period including potentially life-threatening complications.
4. Posterolateral fusions: equivalent or greater early postoperative risk of morbidity compared with ICBG harvesting for this dosage; 16-20% of rhBMP-2 subjects had adverse back and leg pain events, a probable two to threefold increase in the first three months after surgery over control groups.

While we still don’t know the full extent of injuries associated with InFUSE, some of the risks being reported to the FDA include:

1. Severe inflammation
2. Severe infections
3. Massive bone loss
4. Graft migration
5. Loss of fixation
6. Epidural Hematoma
7. Retrograde ejaculation
8. Persistent bladder retention
9. Severe back and/or leg pain
10. Overgrowth or uncontrolled bone formation (ectopic bone growth)
11. Male sterility
12. Cancer

In many cases, patients will need revision surgery to correct adverse events associated with InFUSE. Further, it now appears that many of these associated risks may be untreatable.

If you or a loved one have undergone spinal fusion using Medtronic’s InFUSE bone graft, and have experienced any side effects, please contact Daniel P. Kondos today.