Friday, November 30, 2012

My tumor growth levels pre and post revision coupled with my chromium and cobalt levels (2 of 2)

Interesting to see how the tumors grew with the revision and how the tumors appear to be receding 12 months after the revision as the chromium and cobalt levels recede.

The revision occurred on Nov of 2011.  The tumors are listed  in the first chart.  You can see how from the date of the revision in 11/11 through 4/12 the tumors were growing.  By July of 2012, the tumors began to stabilize.

The chromium and cobalt levels are in the second chart.  You can see the dramatic decrease in the levels which likely resulted in the tumors stabilizing.  Both of my oncologists commented that it seems for now, the tumors are stabilized.  This is very good news.  We are not sure for how long but I would be happy if they just don't grow again.  While the Cr and Co is not gone, hopefully, the growth of the tumors will continue to be stabilized.

You can see in the chromium and cobalt chart that there was a drastic decrease in blood metal levels over the year following the revision. So the levels after the 3/9/11 reading are all post revision levels.

Wednesday, November 28, 2012

My Tumor growth data post hip revision ( 1 of 2)

Pre revision:

I was released from 5 years of cancer monitoring post nephrectomy with no signs of recurrence of the cancer.....then the hip revision happened in 2012 and one month later, look what happened

Post revision:


Tomorrow, I will show you how the decreasing Cr and Cobalt levels map to the stability of the tumors.  Very interesting stuff indeed.  Some say all of of these relationships might be coincidental:
  • I was released from 5 years of CT monitoring post nephrectomy  (removal of one of my kidneys due to a cancerous growth.)  The first table above shows that my scans were pretty clear for 5 years.
  • One month following the revision, all of these tumors grew.  I believe there is a relationship between the tumor growth and the revision due to the documented research findings of oxidative stress which is caused with these metals. In a revision surgery, it has certainly been demonstrated  that more metal sloughing occurs at the time of revision surgery which is perfectly logical with all of the chopping and twisting and turning that occurs to remove a prosthetic.
  • Since the revision a year ago, my chromium and cobalt levels have dropped dramatically.  I will add those measures to these dates so you can  see the relationships now in the tumor stability.
All completely fascinating. 

Tuesday, November 27, 2012

MR Imaging of Metal-on-Metal Hip Prostheses

    2013 Feb;21(1):155-68. doi: 10.1016/j.mric.2012.09.005.



    Division of Musculoskeletal Imaging, Department of Radiology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.


    Metal-on-metal (MoM) hip arthroplasty was expected to provide benefits over metal-on-polyethylene systems. After widespread placement of MoM implants, outcomes have been disappointing. MoM implants are associated with higher serum levels of metal ions, adverse periarticular soft tissue reactions, and increased long-term failure rates. In light of these findings, it is crucial that patients with MoM implants be closely monitored for adverse effects. MR imaging is ideally suited for assessment of these patients and complements standard clinical evaluation and laboratory testing. This article reviews the background of MoM implants, emerging data on complications, strategies for using MR imaging, and MR imaging findings in patients with reaction to metal.

    Delayed sciatic nerve palsy following resurfacing hip arthroplasty caused by metal debris.

    2012 Nov 14;2012. pii: bcr2012006856. doi: 10.1136/bcr-2012-006856.



    Joint Reconstruction Unit, Royal National Orthopaedic Hospital, Stanmore, UK.


    The rapid rise in the incidence of failed metal-on-metal hip articulations in recent years has led to many patients requiring complex revision surgery. These failed metal prostheses may produce local metallic debris, which promotes both local and systemic adverse effects. We report an unusual case of failed metal-on-metal resurfacing hip arthroplasty presenting with ipsilateral buttock pain and foot drop 6 months after surgery. After thorough investigations, the metal-on-metal bearing was revised to a metal-on-polyethylene total hip replacement. This resulted in marked improvement in the systemic symptoms, inflammatory marke and metal ion levels postoperatively. However, neither clinical nor neurophysiological sciatic nerve recovery followed. The patient eventually required tendon transfer surgery for her persistent foot drop.

    Monday, November 26, 2012

    Literature Summary of Chromium and cobalt levels (2 of x)

    A few months ago, I published the summary of the findings from the American Academy of Orthopedic Surgeons Of their review of all of the key studies done on the MoM hip implants.  they reviewed 3038 documents that were consistent with their standards of review to reach conclusions re the MoM hip issues.

    Metal-On-Metal Hip Implants-a Technology Overview by the American Academy of Orthopaedic Surgeons ( 1 of x)

    I just completed my follow up on the metal levels in my body over time (pre and post surgery). You can see the levels  below: (my revision took place in November of 2011.

    chromium BloodCobalt Bloodchromium SerumCobalt Serum Cr24 hour urineCo 24 hour urine
    1/4/201128 mcg/l34 mcg/l
    1/30/201186ug/l10 ug/l
    2/9/201121.6 ug/l24 ug/l
    3/29/201146.85 ng/l28.5 ng/ml
    3/8/20127.5 mg/l2.5 mg/l 
    7/3/201211.74 ng/l1.57ng/l

    I am really taken aback at the levels found in the literature summarized by the American Academy of Ortho surgeons (AAOS) from their literature survey. Specifically, I was interested in seeing the low levels of Cr and Co pre and post revision vs my levels. My levels were really high compared to what was found in the literature. See that table  for Chromium levels and  cobalt levels from the various studies

    Thursday, November 22, 2012

    Biomet Hip Replacements

    Drug Watch

    Biomet, a medical device manufacturer, was founded in Indiana in 1977. In 2007, Biomet was purchased by a group of private companies, including Goldman Sachs Capital Partners and the Blackstone Group. Today, Biomet’s annual sales top $2.5 billion, its products are distributed in 90 countries, and it employs more than 7,000 people around the world. In 2010, Biomet’s U.S. hip implant sales were $312.9 million, accounting for 12 percent of the domestic hip implant market.
    The company has contributed a number of new technologies to the orthopaedic device industry, including direct molded polyethylene, titanium alloy reconstructive products and PPS porous plasma spray coating. Biomet has expanded to dental implants, bone-healing technologies, and products to treat trauma, sports injuries and spinal injuries. However, replacement devices for the hip, knee, shoulder and other joints remain a large part of Biomet’s products lineup.

    Despite Biomet’s success, it has had its share of problematic devices, specifically the M2a Magnum hip implant products and the Stanmore and Exceed ABT devices with optional metal liners. The problems stem from their metal-on-metal design. MoM hip implants like the M2a Magnum, Stanmore and Exceed ABT can cause a variety of complications, including metallosis, which is metal poisoning that occurs when metal particles are released into the blood from the artificial joint. The U.S. Food and Drug Administration (FDA) received hundreds of reports of complications from doctors and patients who have used the M2a Hip implant line of products, however, the devices have not been recalled. A number of patients filed lawsuits against the company for complications such as pain in their hips, dislocation and soft tissue damage that necessitated revision surgery.

    Biomet’s Hip Replacement Products

    Biomet manufactures hip replacement devices for all types of hip replacement surgeries. These devices include primary femoral and acetabular components, as well as revision components. Revision components are used in surgery to replace faulty or failed implants from the original hip replacement surgery. Biomet’s implants come in a variety of materials such as ceramic, metal and polyethylene plastic. The company claims that components manufactured with its exclusive E1 Antioxidant Infused Technology have a lower wear rate than other polyethylene products.

    Biomet also produces a number of metal-on-metal (MoM) hip replacement prostheses — which use two or more metal components. In addition to its popular M2a Magnum line of implants, Biomet manufactures other MoM designs, including the Biomet Stanmore and Exceed ABT . According to Biomet, the company produces the widest range of MoM hip devices in the industry. They have also improved upon the MoM monoblock component design. Unlike modular hip systems, which include a number of interchangeable parts, the parts of monoblock implants are designed as a single piece. Acetabular monoblock components, which are Biomet’s specialty, come with the liner, cup and ball as one piece; monoblock femoral components come with the ball, neck and stem as one piece.

    Monoblock acetabular components are used without screws and are pushed into the hip socket. The porous coating on the outside of these implants encourages bone growth without the need for screws to hold the implant in place. Monoblock acetabular implants do not rely on a locking mechanism to hold the liner in place because the liners are machined into the inside of the cup. Some studies have shown that these one-piece components have less debris buildup because there are fewer moving parts.
    Primary Femoral Components
    Answer Hip SystemBalance Femoral Component
    Bi-Metric Porous Primary Femoral ComponentBi-Metric Interlok Femoral Component
    Bio-Groove HA Hip SystemBiomet Hip Fracture Femoral Component
    Bio-Moore II Hip SystemGeneration 4 Polished Hips System
    Integral Centralizer Femoral ComponentIntegral Reduced Proximal Profile Femoral Component
    Rx 90 Smooth Primary Femoral ComponentStanmore Hip System
    Mallory-Head Interlok Femoral ComponentTaperloc Hip System
    Revision Femoral Components
    Bi-Metric Head/Neck Replacements
    Bi-Metric Long Stems
    Integral 180 Femoral Component
    PLR Proximal Loading Revision Stem
    Reach Modular Revision System
    Reach Revision System
    Rx 90 Revision System
    Mallory-Head 1pc Calcar Femoral Component
    Mallory-Head Modular Calcar Revision System
    Arcos Modular Femoral Revision System
    Primary Acetabular Components
    Bio-Clad Polyethylene Acetabular ComponentC2a – Taper Acetabular System
    Full Hemisphere Solid Acetabular ComponentM2a – Ringloc Liner
    M2a – Taper Acetabular Hip SystemM2a – 38 Metal-on-Metal Acetabular Hip System
    QSAC Quadrant Sparing Acetabular ComponentRanawat/Burstein Polyethylene Acetabular Component
    RingLoc Acetabular LinersRingLoc Acetabular Series
    RingLoc Bi-Polar Articulating Hip SystemRx 90 Low Profile Acetabular Component
    Rx 90 Polyethylene Acetabular ComponentTri-Spike Acetabular Component
    Universal Acetabular ComponentVision Acetabular Component
    Mallory-Head Radial Acetabular ShellM2a-Magnum Large Metal Articulation
    Revision Acetabular Components
    Biomet Tri-Polar Acetabular System
    Freedom Constrained Liner
    Healey Flanged Revision Acetabular Component
    Par 5 Acetabular Reconstruction System
    Recovery Protrusio Cage
    Mallory-Head +5 Acetabular Component
    Regenerex Acetabular Reconstruction System

    Biomet’s M2a Magnum Hip Implants

    The company released its lucrative M2a line of MoM implants in 1996, beginning with the M2a RingLoc. From 1999 to 2009, more than 110,000 M2a devices were implanted. According to Biomet, the M2a design increases long-term performance, allows for a wider range of motion and decreases dislocation.
    The M2a line includes the following models:
    • 28mm M2a-Taper
    • 32mm M2a-Taper
    • M2a-38
    • M2a-Magnum
    • M2a-Magnum Tri-Spike
    • M2a-RingLoc
    The M2a Magnum Large Metal Articulation device was released in the Unites States in 2004 and is one of the company’s bestselling devices. Following the release of this device, all M2a implants were consolidated under the M2a Magnum brand. These devices are monoblock implants, and each M2a model has slight differences in design to accommodate different patient needs. The M2a Magnum line includes several acetabular products, all of which are made up of the cup (or shell), metal liner and metal ball. The M2a Magnum products are intended for use with a non-cemented surgical technique and can be used for primary or revision surgery.

    In M2a Magnum products, the acetabular (hip socket) cup’s outer surface is coated with porous titanium alloy that encourages bone growth, and the inside of the shell is made of cobalt chromium (CoCr) alloy. All of the components of the M2a Magnum line are metal, and surgeons have the choice of a few stems that are designed to work with this prosthesis. These implants are designed for active people, and the larger head diameter has the potential for more than 160 degrees of motion. Surgeons also have a wide range of head sizes, allowing them to more closely fit the patient’s anatomy. The downside to these larger heads is that the surface area rubbing against the inside of the cup is larger, and this increases surface wear. This means more metal particles may be released into the blood and surrounding tissues.

    The M2a Magnum Large Metal Articilation System is endorsed by former Olympian Mary Lou Retton, who suffered from hip dysplasia and damage to her hips from her career as a gymnast. Retton received a total hip replacement using this device, along with Biomet’s Taperloc Hip Stem, in 2005 at the age of 37.

    Problems with the M2a Magnum Metal-on-Metal Hip

    The M2a Magnum products may offer greater range of motion and less wear, but the implants are not without their problems. In fact, 450 adverse events have been reported to the FDA by patients and doctors related to M2a Magnum products, and the number will most likely grow. These events include pain, swelling, premature device failure and fracture.

    Another problem with the M2a Magnum line is metallosis, which can occur with any metal-on-metal implant. When the metal surfaces of ball and socket rub against each other, they release metal debris. The debris can cause damage in the tissues around the joint, leading to several problems such as tissue discoloration, tissue necrosis (death), pockets of fluid called pseudotumors, groin pain, swelling, and loosening of the prosthesis leading to dislocation or fracture.

    The M2a Magnum uses cobalt chromium (CoCr) in the inside of its shell and also for the ball, which can lead to excessive metal particles being released into the blood. Patients implanted with the M2a Magnum have suffered from pain, pseudotumors, extensive soft tissue damage and loosening of the component less than a year after implantation. All of these conditions require revision surgery to correct. In addition, the metal particles in the blood can travel to other organs and cause complications.

    Biomet Hip Replacement Lawsuits

    The M2a Magnum line was approved for distribution in the United States by the FDA under its 510(k) approval system. This means that it was not tested prior to release, since similar products already existed on the market. Because of the growing number of people developing pain and disability as a result of the M2a Magnum, the number of lawsuits filed against Biomet over the design is also growing.

    The judicial panel on multidistrict litigation ordered that the cases be consolidated and transferred to the Northern District of Indiana, where Biomet is headquartered. The panel also noted the growing number of complaints alleging that the metal-on-metal design of the M2a Magnum causes dangerous levels of metal particles in the blood and surrounding tissues.

    The year 2012 was a difficult one for Biomet. In March, Biomet was sued by the Securities and Exchange Commission (SEC) under the Foreign Corrupt Practices Act. The SEC claimed that Biomet and its subsidiaries bribed doctors in Argentina, Brazil and China to use its products from 2000 to 2008. Biomet reportedly kept false records of these bribes, claiming they were “commissions,” “royalties” or “scientific incentives.” The company agreed to pay $22.9 million to settle the charges.

    New Zealand’s Regulatory Agency Issues Zimmer Durom Cup Warning

    Perry Larkin | November 21st, 2012 | Posted in Zimmer Hip Lawsuits
    The Zimmer Durom Cup has been the recipient of numerous complaints and resultant filings of Zimmer hip lawsuits. Problems such as device failure, premature loosening, metal contamination, pain and instability have been reported. Each federal lawsuit filed because of Zimmer hip has been centralized in the ongoing multidistrict litigation located in New Jersey.

    Due to the complications with the device, Zimmer suspended sales in 2008, but no recall was issued. Following an investigation, Zimmer Orthopaedics found that the device was not defective and it was re-released onto the market a month later with updated surgical instructions. By then, hundreds of affected patients had already chosen to file cases seeking compensation for their injuries. In addition, Dr. Lawrence Dorr, a prominent orthopedic surgeon, warned colleagues of his patients experiencing premature failures of their devices.

    If a patient was not warned, they still may be eligible to file a lawsuit.

    Zimmer Durom Cup is the fifth device to receive an international warning

    On October 26, 2012 the New Zealand health regulatory agency, Medsafe, issued a warning to doctors and patients regarding the Zimmer Durom Cup hip device stating that it has a higher likelihood of failure than comparable hip devices. This warning alerts doctors and patients to be vigilant about possible Zimmer hip complications.

    Along with the Birmingham Modular Health, the Smith and Nephew R3, the Mitch TR, and DePuy ARS, the Zimmer Durom Cup is the fifth metal-on-metal device to receive an international warning.
    Months ago, surgeons in New Zealand were asked to monitor patients who received metal-on-metal devices such as the Zimmer Durom Cup on an annual basis. This device was first released onto the market in New Zealand in 2003, but the company discontinued it in June of 2011. During the time it was available, it was used in a total of 252 implants in the country.

    Report states around 16% of Zimmer Durom Cup patients will experience problems

    According to Medsafe, around 16% of people implanted with the Zimmer Durom Cup will experience problems. This is higher than the average of 10% failure rate that is seen with metal-on-metal devices in general.

    Dr. Stewart Jessamine, the Medsafe Group Manager, states, “There is a greater awareness by manufacturers and regulators about these devices, which is why were are seeing more of these alerts.”

    Metal implant complications can lead to many problems including death

    A plaintiff filing a case alleging Zimmer Durom Cup complications is likely to claim metal contamination and premature loosening. The way the device is formulated, a metal cup is placed inside a metal socket and the components have the potential to rub against each other during normal wear and tear. This might shed tiny shards of metal—cobalt and chromium—into the joint’s surrounding tissues.

    This type of metal contamination might lead to tissue damage, pseudotumors, inflammation, and possibly death. It can also lead to loosening of the implant. Plaintiffs claim that Zimmer should have provided a better warning regarding these risks.

    Wright Medical Hip Replacements

    Wright Medical Technology Inc. is headquartered in Arlington, Tenn., and has been designing, manufacturing and marketing joint implants since 1950. About 60 percent of the company’s sales come from its hip and knee products. The company sells its products in more than 60 countries and had $480 million in worldwide sales for the first eight months of 2012. The company employs about 1,300 people globally and has branches in Canada, Japan and Europe.

    While it is also known for its foot and ankle devices, the core of the Wright Medical product lineup has always been hips and knees; it controls about 2 percent of the U.S. hip and knee market. The company’s contributions to the innovation of hip replacements include its ceramic hip system, hard-bearing surfaces and proprietary neck modularity. Studies have shown that hard-bearing surfaces such as ceramic or metal produce less particle wear when paired with another hard-bearing surface as opposed to a soft-bearing surface like polyethylene plastic.

    Wright uses alumina oxide ceramic to manufacture its LINEAGE liners and femoral heads to create an industry-leading ceramic-on-ceramic hip system. According to Wright, this particular coupling of ceramic parts generates less wear debris than ceramic-on-plastic or metal-on-plastic systems. Some studies have corroborated this data, revealing that after nine years, alumina-on-alumina hip prostheses had a 97.8 percent survival rate. Ceramic-on-ceramic prostheses are not without their problems, however. People who received these implants have reported squeaking in the joint, and ceramic has a tendency to fracture.

    Wright has experienced success with its ceramic-on-ceramic products, though the same cannot be said for its metal-on-metal (MoM) products. Wright’s CONSERVE line of MoM hip replacement systems and its Profemur Z Stem have caused a number of complications in people who received these implants. Like other MoM implants, the CONSERVE hip system is prone to shed metal particles into surrounding tissues and the blood, leading to high levels of metal and metal toxicity. This may lead to metal poisoning (metallosis), tissue necrosis (death), loosening and other serious problems. The Profemur Z Stem is also under scrutiny because it is prone to fracture and fail early. A number of people have already filed lawsuits against Wright as a result of early device failure, pain, excessive metal ions in the blood and the need for expensive revision surgery because of the faulty design.

    Wright Medical’s Hip Replacement Products

    Wright Medical manufactures a wide variety of hip replacement devices, including components made from ceramic, metal and polyethylene plastic. The products are designed to be used to correct a variety of hip problems, from osteoarthritis to trauma and fractures. Wright’s hip replacements systems can be used with cemented or non-cemented techniques for primary and revision hip replacement surgery, and hip resurfacing.
    CONSERVE Femoral Surface Replacement
    CONSERVE PLUS Total Resurfacing Hip System
    Acetabular Systems
    DYNASTY Acetabular Cup System
    GLADIATOR Bipolar Hip System
    INTESEAL Acetabular Cup System
    LINEAGE Acetabular Cup System (Polyethylene)
    PROCOTYL E Acetablar Cup System
    CONSERVE Total Hip with BFH Technology
    CONSERVE Total A-CLASS Advanced Metal with BFH Technology
    Femoral Stems
    PERFECTA Plasma Spray Stems
    PROFEMUR E Hip Stems
    PROFEMUR LX 5/8 Stem
    PROFEMUR TL Total Hip System
    PROFEMUR Total Hip System
    PROFEMUR Z Hip Stems
    PERFECTA RS & IMC Slim Neck
    PERFECTA Total Hip System
    Revision Systems
    LINK MP Reconstruction Hip Stem
    PROFEMUR LX 5/8 Revision Stem
    PROFEMUR R Revision Prosthesis

    Wright Medical’s CONSERVE Hip System and PROFEMUR Z Stem

    Wright Medical’s CONSERVE hip replacement line was created to respond to the demand for durable implants for younger, more active people. One of the greatest concerns that doctors face when younger patients develop hip problems is finding an implant that can withstand an active lifestyle. According to Wright Medical, its CONSERVE MoM implants provide excellent range of motion with low particle wear and long-term dependability. The larger femoral head (ball) size of the CONSERVE implants closely mimics the natural anatomy of the hip and allows up to 169 degrees of motion. In addition, the high-carbon, cobalt chrome cup and cobalt chrome ball are designed to reduce wear. This linerless design is referred to as a monoblock design because the acetabular cup and the liner come as one piece. The outside of the cup features a beaded, porous coating that encourages bone growth. The femoral heads range from 36mm to 54mm and are among the largest in the industry.

    Wright also claims its CONSERVE hip replacement designs reduce the chance of soft tissue impingement, which can lead to dislocation. Some studies have shown that increasing the size of the ball results in fewer dislocations.
    The products included in this line of hip replacement products are:
    • CONSERVE Plus Total Hip Resurfacing System (2009)
    • CONSERVE Total Hip with BFH Technology (2003)
    • CONSERVE Total A-CLASS Advanced Metal with BFH Technology (Patent pending)
    The CONSERVE Total Hip acetabular cup and ball are designed to be used with a number of stems, including the PROFEMUR Z. The PROFEMUR Z is a modular neck and stem system that is made of titanium alloy. The femoral stem fits inside the thigh bone and connects to the neck, which in turn connects to the ball. The PROFEMUR Z is designed for use with a minimally invasive surgical technique and simplifies insertion into the bone. The stem is dual tapered, and the upper half of the stem is rectangular in shape. The surface of the stem is grit-blasted to create a rough surface that allows better bonding with the bone.

    The PROFEMUR Z system includes the stem and a choice of six interchangeable neck pieces available in two lengths. Modular necks and stems allow surgeons to customize length for each patient to provide a better fit, especially in complex revision surgeries. However, there is growing concern in the orthopaedic community regarding the stability and design integrity of modular stems. In fact, metal necks and metal stems can create friction and problems similar to the metal ball-metal cup issues.

    Problems with CONSERVE Plus and PROFEMUR Z System

    Wright Medical claims that its CONSERVE line of hip replacement systems offers superior design that reduces wear and dislocation rates. However, the CONSERVE Plus Total Hip Resurfacing System has demonstrated higher than normal failure rates. The Food and Drug Administration (FDA) has received reports of more than 200 adverse events of device failures, severe pain in the hip and groin, loosening and high metal toxicity in the blood because of the metal-on-metal design of CONSERVE Plus implants.

    While no recall has been issued yet, the CONSERVE Plus bears a striking resemblance to the DePuy ASR. The ASR was recalled after a high number of device failures caused severe complications in a number of people. Many who received the ASR device have since filed lawsuits against DePuy. Like the DePuy ASR, Wright’s CONSERVE Plus is a cementless, monoblock device with a cup and large femoral head made from cobalt chromium. The cups of both implants feature beaded porous coating. These two systems are also marketed to active individuals. Another similarity between these devices is the unusually high revision rate. According to the National Joint Registry of England and Wales, the five-year revision rate for the CONSERVE Plus is 8.36 percent. This rate is second only to the DePuy ASR, with a rate of 9.63 percent.

    Because of its metal-on-metal design, the CONSERVE Plus system can cause a number of problems.
    The FDA warns that metal-on-metal hip devices like Wright’s CONSERVE hip replacement systems can cause the following adverse effects:
    • Pain in the groin, hip or leg
    • Limp or decrease in ability to walk
    • Swelling in or near the hip joint
    In addition, metal-on-metal implants are known to cause metallosis. This is a condition caused by an excessive amount of metal particles in the blood.
    The FDA warns that metallosis can cause problems involving other parts of the body such as the heart, nerves, thyroid and kidney, including:
    • Chest pain, shortness of breath
    • Numbness
    • Changes in vision or hearing
    • Fatigue
    • Feeling cold
    • Weight gain
    • Urinary trouble
    The PROFEMUR Z stem is also a source of concern for many hip replacement recipients and their doctors. According to a report from the Australian National Joint Registry, 1 in every 9 patients who received a PROFEMUR Z stem has been forced to undergo revision surgery due to device failure. Complications such as corrosion, femoral neck fracture and fretting were reported. Fretting occurs when two opposing surfaces rub together and cause wear damage. Several lawsuits have already been filed, claiming negligence and faulty design. When the CONSERVE Total Hip is used with a PROFEMUR Z stem, the resulting complications can be exponentially worse.

    Wright Medical Hip Replacement Lawsuits

    Both the CONSERVE Plus and PROFEMUR Z stem have been implanted in thousands of people, some of whom have filed lawsuits after having to undergo revision surgery to correct painful complications such as metallosis, loosening, severe pain, device failure and device fracture. One man filed suit against Wright in 2011 after the titanium neck of his PROFEMUR Z stem fractured while he was getting dressed for work. He had to have emergency surgery when his hip suddenly gave out and he suffered intense pain. Surgeons had to remove the fractured bits of titanium from his body.
    Many suits have also been filed against Wright Medical for problems with the CONSERVE hip replacement systems. These lawsuits were consolidated under one judge in the U.S. District Court for Northern Georgia. The complaints allege that the device releases high levels of metal particles in the blood that can cause loosening and device failure because of Wright’s faulty metal-on-metal design.
    Wright is no stranger to lawsuits. After an investigation that started in 2007, the federal government sued the company for questionable business practices involving bribing doctors to use their products. In order to avoid admitting any wrongdoing, the company agreed to pay $7.9 million in fines in 2011.

    Smith and Nephew Hip Recall

    Drug Watch

    Smith & Nephew is a London-based medical device manufacturer that manufactures several lines of joint replacement systems for hips, knees and shoulders. The company is the fourth largest manufacturer of hip implants in the United States, with a 12.1 percent market share and $313 million sales in 2010. It has also had its share of defective devices and hip implant recalls, however. In the United Sates, many recalls of defective joint implants are voluntary and initiated by the manufacturers. This usually happens when too many adverse events occur as a result of the device. The U.S. Food and Drug Administration (FDA) will step in if the manufacturer refuses to voluntarily recall a defective product. In 2012, Smith & Nephew issued a voluntary recall for the metal liner in one of its hip implant devices, the R3 Acetabular System.

    The R3 Acetabular System was released in Europe and Australia in 2007, and in 2009 the hip replacement system was launched in the United States. Smith & Nephew initiated a worldwide recall of the metal liner in its R3 Acetabular System on June 1, 2012, after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation. About 7,700 R3 devices have been implanted worldwide since 2009. The device experienced a higher than normal revision rate — 6.3 percent in four years compared with the average of 2.89 percent for primary total hip replacements. In the recall, Smith & Nephew stated that the metal liner was not “performing as well” as the company expected and that it was “not satisfied with the clinical results.”

    However, the company still claims that the modular R3 Acetabular System is designed to enhance stability and give surgeons more options. The R3 system remains on the market and now includes a cup made of plastic, metal or ceramic; a femoral head made of the company’s proprietary OXINIUM Oxidized Zirconium, cobalt chrome or Biolox ceramic; and a liner made of OXINIUM or cross-linked polyethylene (XLPE) plastic. When used with the metal liner, the R3 Acetabular System can become a metal-on-metal (MoM) implant. Like other companies that manufacture these types of implants, Smith & Nephew marketed the metal liner option of the R3 Acetabular System as durable and wear-resistant. However, instead of long-lasting durability, an alarming number of these implants have failed prematurely.

    Complications and Problems with the R3 Acetabular System

    Complications and problems relating to the metal liner of the R3 Acetabular System may be the result of its MoM design. The metal liner is made of cobalt and chromium. Cobalt-chromium implants have been shown to release ions into the body, and studies have revealed that chromium and cobalt ions are carcinogens linked to blood poisoning and genotoxicity (DNA damage). The ions can cause local tissue reactions that destroy muscle and bone and spread to other organs. Cobalt has also been linked to cardiomyopathy, or heart muscle disease. The deterioration of bone and muscle around the implant can lead to loosening and device failure. All of these complications have been known to lead to metallosis, which is also known as metal poisoning.

    Studies by Australia’s National Joint Replacement Registry and the United Kingdom’s National Joint Registry did not find evidence of metallosis–metal poisoning–­occurring in patients who were implanted with the metal liner of the R3 Acetabular System. However, patients did experience metal sensitivity and other complications that can lead to metallosis. It is important to note that MoM hip implants manufactured by other companies have presented metallosis as a complication, and this may be a future concern for R3 Acetabular System recipients.

    After the recall, the company sent out “hazard alert” letters to doctors who had implanted the metal liners, claiming that the recall was a “precautionary step.” Smith & Nephew also said it was unable to identify one single reason for the device failure, but there were reports of “infection, dislocation, metal sensitivity, loosening/lysis and fracture.”The letter further instructed doctors to follow up with their patients if they had received the liner.

    While there have been no recalls for the OXINIUM ceramicliner of the R3 Acetabular System, the U. S. Food and Drug Administration (FDA) issued a warningin December 2010 to Smith & Nephew for this component. Specifically, Smith & Nephew did not follow protocol in documenting manufacturing procedures, including sterilization of the product and machine settings used to manufacture the titanium rings in various ceramic inserts. The FDA also noted that batches of the products did not meet minimum sterilization requirements. The FDA concluded that these practices and others were “not in conformity with the Current Good Manufacturing Practice (CGMP) requirements.”

    Smith & Nephew Lawsuits

    Almost 4,000 of the R3 Acetabular metal liners were used in the United States between 2009 and the June 1, 2012, recall. Because of its metal liner, people who received this implant have suffered a number of complications. Studies have already shown that a high number of R3 Acetabular Systems with the metal linerfailed prematurely and required revision surgery.


    [From connie:  note this is not a recall notice for the R3. This article is merely pointing out some potential issues with this device.]

    Tuesday, November 20, 2012

    Riegel v. Medtronic, Inc

    I wonder why I have never heard of this case before?  Pretty amazing statute and process re medical devices... a story to write a book about in terms of how we make laws to protect patients and then proceed to allow loopholes to get around the laws!

    I can't quite characterize this story but it is worth reading.

    Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), is a United States Supreme Court case in which the Court held that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

    It modified the rule in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).


    Testing Manufacturer Liability in FDA-Approved Device Malfunction

    The Supreme Court’s ruling in Riegel v. Medtronic, Inc., may prevent consumers injured by medical devices that have FDA premarket approval from receiving compensation.

    Ryan Bailey and Kristin E. Schleiter, JD, LLM

    In 1996, an Evergreen Balloon Catheter, marketed by Medtronic, Inc., burst during Charles Riegel’s angioplasty [1]. The catheter had been granted premarket approval (PMA) from the Food and Drug Administration (FDA) in 1994. While the manufacturer’s instructions recommended that physicians inflate the catheter to only 8 atmospheres, the treating physician in Riegel’s case inflated the catheter to 10 atmospheres before it burst. As a result, Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery.

    Riegel and his wife filed a product liability complaint against Medtronic. A federal district court dismissed the complaint, holding that federal legislation—the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act [2] preempted the state negligence and liability claims the Riegels cited in their case against Medtronic. The case eventually made its way to the U.S. Supreme Court.

    Riegel v. Medtronic, Inc. brings to light a conflict between manufacturers who have obtained FDA approval and injured patients who want to retain the option of seeking restitution for damages resulting from defective medical devices [3]. Patients who believe defective devices caused their injuries take little comfort in knowing that the devices had FDA approval. Conversely, device manufacturers who received FDA approval after extensive review want to avoid repeating the review process in the courts. In Riegel, the Supreme Court addressed whether the preemption clause of the Medical Device Amendments bars state law claims that challenge the safety and effectiveness of a medical device given premarket approval by the FDA.

    Summary of the Medical Device Amendments of 1976

    The Medical Device Amendments (MDA) of 1976 established three regulatory classes of medical devices. Class I medical devices, which include elastic bandages and examination gloves, are subject to “general controls,” such as labeling requirements [4]. Class II medical devices, which include powered wheelchairs and surgical drapes, are subject to “special controls,” such as performance standards [4].

    The most regulated medical devices are those in Class III, which the amendments define as devices that support or sustain human life, are “of substantial importance in preventing impairment of human health” or “present a potential, unreasonable risk of illness or injury” [4]. Class III medical devices include replacement heart valves and the catheter used on Charles Riegel. These devices are subject to a rigorous premarket approval (PMA) process that includes:
    • full reports of all studies and investigations of the device’s safety;
    • a complete statement of the device’s components, ingredients, and properties;
    • a detailed description of the methods used in, and the facilities and controls used for, the manufacture and processing of the device;
    • samples of device components required by the FDA; and
    • a specimen of the proposed labeling [1].
    The FDA grants premarket approval to Class III devices only after determining that there is reasonable assurance of their safety and effectiveness [5]. In making this determination, the FDA weighs any probable benefit to health from the use of the device against any probable risk of injury in light of available alternatives. For example, a ventricular assist device for children with heart failure was approved, despite a survival rate of less than 50 percent in children using the device, because no other device had a higher survival rate [1]. However, a Class III device that fails to meet PMA requirements is considered unmarketable [4].

    At issue in Riegel was the Medical Device Amendments’ preemption clause. In general, preemption clauses provide that federal laws that conflict with state laws will trump, or “preempt” them [6]. The preemption clause in the Medical Device Amendments prohibits states from establishing a requirement with regard to any device intended for human use that is different from, or in addition to, any federal requirement applicable to the device [5]. The preemption clause also forbids states from establishing any requirement that relates to the safety or effectiveness of a device intended for human use [5].

    How Safe is Safe Enough?

    The dispute in Riegel centered on the amount of regulation necessary to ensure the safety and effectiveness of medical devices. Medtronic argued that letting state claims proceed against devices that had passed the premarket approval process would usurp the power of the FDA, because the PMA process was designed to assure the safety and effectiveness of medical devices [7]. The Riegels countered that Congress never intended the FDA’s power to regulate medical devices to negate the right of private citizens to sue negligent manufacturers [8].

    The Riegels also contended that FDA regulations alone were not enough to protect consumers, since no amount of rigor in the premarket approval process could predict all possible outcomes or problems with a device and its use. Without the threat of litigation, the Riegels argued, manufacturers could attempt to hide safety flaws from the FDA [9].

    Medtronic challenged the plaintiffs’ assertion that the threat of litigation would improve product safety. Instead, it argued, state restrictions would reduce innovation in the development and availability of beneficial medical devices [7]. Moreover, Medtronic argued, because manufacturers factor the cost of potential litigation into product prices, increasing the threat of litigation would increase the cost of health insurance and put some devices out of reach of potential consumers [10].

    Interpreting the Medical Device Amendments and Applicable Precedent

    To settle this dispute, the Supreme Court turned to judicial precedent and the plain text of the Medical Device Amendments’ preemption clause. In particular, the Court relied on its 1996 decision in Medtronic v. Lohr. In Lohr, the Supreme Court had ruled that the Medical Device Amendments preempt state requirements only when the FDA has established “specific counterpart regulations or there are specific requirements applicable to a particular device” [11]—in other words, only when the FDA has a regulation that covers the same safety aspect or the same device that the state requirement covers. The Court rejected the Medtronic contention that general labeling requirements for all medical devices fall under this “specific counterpart” description [10].

    Unlike general labeling requirements, premarket approval entails an in-depth review of a specific medical device. Writing for the majority, Justice Scalia stressed that the premarket approval process for medical devices is one that is rigorous and highly individualized [1]. The Court held that because “premarket approval is specific to individual devices” it constitutes “federal safety review” which, under the Medical Device Amendments, preempts state law [1]. Because the Medtronic catheter that burst during Charles Riegel’s angioplasty had premarket approval from the FDA, state claims against its manufacturer were invalid under the Medical Device Amendment and Lohr [1]. In support of this holding, Justice Kennedy emphasized during oral arguments that, if state law damage claims were not preempted by federal regulations, state juries would be asked to repeat the demanding review process already completed by the FDA for any potentially hazardous device [3].

    The Effect of the Ruling

    By ruling against the Riegels, the Supreme Court refused to allow injured patients to sue device manufacturers whose products pass the FDA’s findings of adequate safety. This ruling prevents courts from enforcing state regulations on medical devices with premarket approval unless those restrictions are identical to corresponding FDA restrictions. Going forward, this may prevent consumers injured by such devices from receiving adequate compensation [8]. Though consumers are not completely without legal recourse—they can still bring suit against negligent manufacturers under state laws identical to FDA requirements or against negligent physicians—the Supreme Court has immunized PMA medical devices from many product liability suits founded in state law, leaving some injured consumers without a common source of judicial remedy [1, 10].


    Medical device classification

    The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

    Device Class and Regulatory Controls

    1. Class I General Controls
      • With Exemptions
      • Without Exemptions
    2. Class II General Controls and Special Controls
      • With Exemptions
      • Without Exemptions
    3. Class III General Controls and Premarket Approval

    The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.

    Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product. A discussion of the meaning of intended use is contained in Premarket Notification Review Program K86-33.


    xxx [from connie]


    I think the hip device was  a class three  device and it did go through the 501K process which I believe essentially  was a "fast track" to the market. Not sure if it was a class two device as it was in Europe for a long time.




    Medtronic Vs Lohr


    Facts of the Case


    The Medical Device Amendments of 1976 (MDA) provides for "the safety and effectiveness of medical devices intended for human use," and classifies such devices based on their level of risk. Class III devices pose the greatest risk and, thus, are subject to a rigorous premarket approval (PMA) process. However, two statutory exceptions to this process exist. Because Medtronic, Inc.'s pacemaker is a Class III device found substantially equivalent to a pre-existing device, it can avoid the PMA process. In 1990, Lora Lohr's Medtronic pacemaker failed, allegedly according to a defect. Lohr and her spouse filed a Florida state-court suit, alleging both negligence and strict- liability claims. Medtronic removed the case to federal district court. The court then dismissed the case as pre-empted by 21 USC section 360k(a), which provides that "no State...may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under [the MDA] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the Act]." Reversing and affirming in part, the Court of Appeals concluded that the Lohrs' negligent design claims were not pre-empted, but that their negligent manufacturing and failure to warn claims were. (This case was decided together with 95-886, Lohr et vir v. Medtronic, Inc.)

    Do the Medical Device Amendments of 1976 pre-empt a state common-law negligence action against the manufacturer of an allegedly defective medical device


    Decision: 5 votes for Lohr, 4 vote(s) against

    Legal provision: Federal Food, Drug, and Cosmetic, and related statutes
    No. In an opinion delivered by Justice John Paul Stevens, the Court held that the Court of Appeals decision was reversed insofar as it held that any of the claims were pre-empted and affirmed insofar as it rejected any pre-emption defense. In a 9-0 vote, the Court allowed the lawsuit based on alleged defects in the pacemaker's design to proceed. In a 5-4 vote, the Court allowed the lawsuit to proceed on its claims of alleged defects in its manufacturing and failure to warn. Justice Stevens reasoned that the MDA was not intended to pre-empt "traditional common-law remedies against manufacturers and distributors of defective devices," as long as they paralleled federal requirements


    Reclassification of Hip devices in Europe from Class 2b to class 3.

    Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices was issued in August 2005, at the behest of France and the United Kingdom. The Directive altered the classification of those devices from Class IIb to Class III for several reasons: the hip, knee, and shoulder are complex joints, the hip and knee are weight bearing joints, the hip and knee are extremely sophisticated implants, shoulder implants are a more recent technique, and hip, knee, and shoulder replacement surgery is increasing in younger patients. Member states were required to transpose the directive into national law by 1 March 2007 and apply its provisions by 1 September 2007.

    US  Classification of Hips in the US now:


    Tuesday, May 24, 2011

    WASHINGTON – Today, U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, wrote Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) commending her Agency’s recent decision to require medical device manufacturers to conduct post-market surveillance for high-risk, metal-on-metal hip implants. In his letter to Hamburg, Kohl suggests that more surveillance of high-risk devices is still necessary, particularly for devices that were approved through the FDA’s fast-track review process.

    Last month Kohl held a hearing examining the FDA’s role in protecting patient safety as part of the medical device approval process. The hearing featured testimony from Ms. Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall.
    Kohl writes: “As stated in the hearing, it is unacceptable that so many high risk, Class III devices continue to be approved through the 510(k) process.

    However, it is encouraging that, during our hearing, FDA pledged to finish either reclassifying the devices or requiring Premarket Approvals (PMAs) for Class III devices currently considered through the 510(k) process. Completing this review is essential to protect the public health.”

    The April 13th Aging Committee hearing is archived online at:

    Full text of the letter copied below.

    May 24, 2011
    Dr. Margaret Hamburg
    The Food and Drug Administration
    10903 New Hampshire Avenue
    Silver Spring, MD 20993

    Dear Commissioner Hamburg:

    I applaud your decision to require medical device manufacturers to conduct post-market surveillance for high-risk, metal-on-metal hip implants. The Food and Drug Administration’s (FDA) use of its 522 regulatory authority will help improve our understanding of the health risks metal-on-metal implants pose to patients. FDA should continue to advance its surveillance of high-risk devices, especially those that have been approved through the fast-track, 510(k) process.

    As you know, last month, the Special Committee on Aging held a hearing entitled, “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process,” in which Dr. William Maisel of FDA participated. The hearing highlighted the problems with metal-on-metal hip implants. A victim of the DePuy ASR hip implant recall, Katie Korgaokar, testified to the distress she experienced with revision hip surgery as a result of the faulty hip implant.
    As stated in the hearing, it is unacceptable that so many high risk, Class III devices continue to be approved through the 510(k) process. However, it is encouraging that, during our hearing, FDA pledged to finish either reclassifying the devices or requiring Premarket Approvals (PMAs) for Class III devices currently considered through the 510(k) process. Completing this review is essential to protect the public health.

    Metal-on-metal hip implants are an example of these Class III devices being cleared through 510(k). It is imperative for patient safety that Class III devices like metal-on-metal hip implants have appropriate review before being marketed to patients, and rigorous oversight once the devices are marketed.

    Again, I applaud and support FDA’s efforts to protect the public health through more vigorous post-market surveillance. I look forward to continue working with FDA to improve post-market device oversight, specifically to ensure that there is adequate post-market surveillance of high-risk devices, like the metal-on-metal hip implants.

    Herb Kohl
    United States Senator

    [from connie]

    Remarkable if you think about all of this went into a full circle:

    1) Hips are classified as a type 3 device  which is a device  that requires premarket approval
    2)  However....the 501 K process allows a fast track to market  if the hip is similar to others on the market so many went through this fast track to get onto the market.
    3) Now in 2011, this Senator wants to ensure premarket approval  of these hips which, if you go back to the beginning of this post was a statute put into  effect  in 1976 which facilitated companies like Medtronics to  have a "get out of jail free card" re liability for manufacturers through this very PMA process ! 
    4) While this law was clarified in 1996, (so it was in effect for 20 years), to ensure that after 20 years, this PMA process was not really  enacted to provide shelter for manufacturers against liability claims, it seems as though we have come full circle with all of these shenanigans!  So from 1976-2013 (37 years) we attempted to deal with the problem of "how do you protect patients safety"...and then proceeded to provide all of the loopholes to work around any of the patient safety legislation.

    If this story doesn't send you into hysterical laughter, you may just want to cry!


    Monday, November 19, 2012

    Government listens to PEALS expert

    Newcastle University in England

    The expertise and advice of a PEALS academic could result in new, tougher laws on the regulation of medical implants. In the wake of problems with metal on metal hip implants, which were investigated by Dr Pauline McCormack (PEALS) and Professor Tom Joyce (Mechanical & Systems Engineering, Newcastle University), and then the PIP breast implant scandal, the Government launched an investigation into how implants are regulated.

    Dr McCormack and Professor Joyce were asked to give evidence to the Science and Technology Select Committee and their recommendations have been accepted by the committee in its report, released this week. The report could lead to new laws if Parliament gives approval.

    Pauline investigated the views of people with failed metal on metal hip implants and explored their thoughts on the current system of medical device regulation, including how the system could be improved for the future. These views were presented to the Select Committee in written and oral evidence. Currently there is little transparency over how medical implants were approved for use, the results of any pre-clinical experiments and who approved them. Also failed implants are often just thrown away so there is no chance to learn why they may have failed. This was deemed unacceptable by Professor Joyce and Dr McCormack and the Select Committee agreed.

    Pauline said: “To our knowledge we’re the only people working directly with affected patients to research the impacts of their hip implant failures and so we thought it was crucial that we present our findings to the Committee. We highlighted patients’ disappointment with the current system of regulation and testing which was causing unnecessary suffering and adding cost to the NHS. There are ongoing reviews into medical device regulation at the EC in Brussels and the FDA in America so our findings have the potential for wide-ranging impact if the report is accepted by Parliament and if other countries follow that lead.”

    PEALS have been collaborating with Newcastle University’s bioengineering team led by Professor Joyce who began investigating the problem of metal hips as far back as 2008.
    If you have a failed metal on metal hip implant and would like to contribute to the research, you can complete a questionnaire about your experiences here.


    For those patients who have not contributed to this study with your story, I strongly suggest you do. This group has spent a great deal of time studying this issue with the Depuy hip and Tom Joyce was one of the three people involved in brining this issue to light in England, far before the US became aware of the issues.  See this link for a background of the New Castle University Group: Also look at this post: