Greater Likelihood of Hip Implant Failure among Women

 New studies seem to point to the fact that women fare less favorably than men after receiving a hip implant. This study comes on the heels of FDA scrutiny of metal-on-metal hip implants in particular. California researchers studied 35,000 cases of artificial hip implants finding the failure rate for women three years post-op was about 2.3 percent while the failure rate for men is approximately 1.9 percent. This includes all types of artificial hip devices—ceramic, polyethylene and metal-on-metal.

Necessity for Hip Implants

The primary reason for implant failure among women was due to dislocation of the artificial implant. The purpose of hip implants is to relieve pain and give back a certain level of mobility to the patient. Arthritis and injuries are often the cause of this lack of mobility and chronic pain. The more active lifestyles of many Americans have resulted in younger and younger recipients of artificial hip devices. For many people the operation provides much-needed relief so while this research should not dissuade those who really need hip replacement surgery from proceeding, women in particular should be very cautious about the type of hip implant they receive.

Problems with Metal-on-Metal Hip Implants

While the metal-on-metal hipimplants are used less frequently among women, they tend to cause the greatest number of problems. In fact, the failure of the all-metal hip implants among women was nearly twice that of the same all-metal implants in men. The all-metal hip implants, while marketed as having a life expectancy of fifteen years or more have suffered many different problems which have caused several manufacturers to recall their all metal hip implants. Lawsuits number in the thousands against these manufacturers from implant recipients who have suffered tissue destruction and death, chronic pain and bone loss, leading to the necessity of a revision surgery. Many of these patients have had metal toxicity and metal poisoning as well, suffering a variety of adverse health symptoms as the cobalt and chromium levels build to dangerous levels in their bodies.

Potential Reasons for Higher Failure among Women

Director at the Hospital for Special Surgery in Manhattan, Geoffrey Westrich, notes that in a separate study he and his collaborators found that women tend to wait longer before they agree to hip implant surgery and they typically report greater amounts of pain than men. The study which found that women are more likely to suffer hip implant failure was funded by the FDA and the specific results were published in JAMA Internal Medicine. Women’s typically smaller joints dictate a smaller femoral head be used in the hip implant.

Those smaller heads have a greater risk of dislocation, leading to revision surgery. Women also tend to have a higher degree of bone density loss, particular after menopause which could also contribute to the higher number of revision surgeries for women. Women considering an artificial hip implant surgery are cautioned to choose a model—other than a metal-on-metal implant—which has been on the market a substantial number of years with the fewest amount of patient problems. 

Following the First DePuy ASR Trial

Kransky v. DePuy—the first ASR metal-on-metal hip implant trial-began on January 25^th in Los Angeles County. Loren Kransky received an ASR hip implant in 2007 and due to severe adverse health effects underwent revision surgery in 2012. Revision surgery is widely considered to be riskier than the original surgery and has a longer recovery time as well. At this time there are over 10,000 lawsuits from recipients of the ASR. On the first morning of the trial Co-Counsel Michael Kelly walked the jury through the original ASR design, the lack of testing prior to marketing and the extreme levels of harm suffered by the Plaintiff as a result.

Risks of the ASR

Kelly referenced documents which clearly reflected DePuy’s knowledge of the potential risks of the ASR—and their lack of action or further studies regarding the implant. Graham Isaac, a DePuy scientist sent an e-mail to other employees which in essence stated that under certain conditions the ASR is susceptible to extreme metal ion levels. Isaac stated in the e-mail “The concern, it has the potential to seriously affect our business.” In other words, while there was concern that the defective product could affect the financial bottom line, there was no evidence of concern for the people who would be receiving the implants.

DePuy’s Counterclaims

DePuy and Johnson & Johnson maintain that Mr. Kransky had an infection—unrelated to the ASR implant—and that the infection was the only reason for the revision surgery. The attorney for DePuy and Johnson & Johnson stated that the cobalt and chromium in the ASR were not responsible for Mr. Kransky’s problems. He further stated that the ASR was thoroughly tested and researched and that Mr. Kransky’s illnesses and adverse medical conditions were due to a history of smoking as well as kidney and heart disease and diabetes.

Safety Improvements Not Implemented

Kransky’s attorney then introduced an e-mail from bioengineer Chris Hunt regarding the health hazards of the ASR as well as introducing a deposition by Mr. Flett regarding Project ALPHA. ALPHA was the code name for a re-design of the ASR which would make certain changes which would increase the safety of the implant. One letter was introduced which stated “a small improvement to geometry could represent a large improvement for many patients.” Removing the groove on the ASR cup would greatly reduce the friction experienced by ASR recipients to approximately three times less than the original design yet these simple design changes were not implemented, presumably because of financial considerations.  Plaintiff’s attorney also introduced an exhibit which clearly showed that the DePuy ASR failed its own safety test and rather than make alterations to the device DePuy simply altered the test. 

Metal Ion Backlash

In the early days of the trial, a DePuy marketing executive, Randall Kilburn, testified regarding a marketing team meeting in July of 2007 in Chicago. During this meeting a Power Point presentation was show with a title of “What Scares us the Most in the Year Ahead?” Of the nine items listed, “Metal ion backlash” was number one.  Kilburn was asked if he was aware of the fact that surgeons were complaining about excessive ion debris shedding from the ASR. Kilburn answered, “When it was malpositioned, yes.”  During the second week of the trial jurors heard that a 2011 internal DePuy study showed that 35.8% of ASR hips failed within four and a half years, requiring revision surgery for the recipient.

Testimony from Kransky’s Daughter

Despite the claims of Johnson & Johnson and DePuy regarding other causes of his illnesses, Kransky’s daughter, Jennifer Flynn gave a moving description of her father as a once self-sufficient man whose health deteriorated rapidly after receiving a DePuy ASR hip implant. Within three years of the implant, Flynn stated, her father needed help bathing and using the bathroom and was soon in a wheelchair, living in a nursing home with round-the-clock medical attention. When her father initially complained of a metallic taste in his mouth Flynn’s first reaction was that he was being poisoned. In response to DePuy’s defense that Kransky’s other illnesses were the direct cause of the implant failure Dr. Robert Harrison testified that the cobalt and chromium ions released into Kransky’s body and bloodstream were the cause of the failure of the implant.

Harrison further stated that Kransky’s normal white blood cell count and lack of fever during his surgery clearly showed that it was not an infection nor underlying health problems which necessitated the revision surgery rather the toxic metals. Graham Isaac, the engineer for DePuy was asked whether he considered 50 plus micrograms of cobalt to be a safe level he answered “that would be high.” According to the California Poison Control any level of cobalt above 7 micrograms per liter are considered harmful—Mr. Kransky’s levels were 53.6 on September 1, 2011—almost eight times the “acceptable” level.

Managing Perceptions

Further into the trial, Plaintiff’s counsel introduced an e-mail message dated May 2, 2008 from Paul Berman, head of DePuy Marketing Department. The e-mail stated that while a cup redesign would ultimately be required, the “short-term action is to manage perceptions.”  This same e-mail detailed the multiple safety concerns regarding the ASR and noted that as an employee of Johnson & Johnson & DePuy he did not feel comfortable with marketing the ASR.

Testimony of Plaintiff During Fourth Week

The Kransky v. DePuy trial is currently in its fourth week and on February 19^th Loren Kransky testified that he dreaded the revision surgery he had a year ago, however he was in constant pain, unable to walk and believed he was being systematically poisoned from the chromium and cobalt ions shearing away from the ASR metal hip implant. Kransky-who had undergone 25 prior surgical procedures-believed the revision surgery could kill him. Kransky stated “I’m going to die either way. One would be slow and one would be fast. I took the lesser of two evils.” During cross examination of Kransky, J & J attorney, Michael Zellers suggested that a fall Kransky allegedly took prior to having the ASR implanted suggested balance problems caused by Kransky’s other medical conditions. It is expected that this trial may well set the tone for the thousands to follow. The MDL consolidated Federal trials are set to begin in May, 2013 and July, 2013.