Tuesday, January 1, 2013

Stryker Rejuvenate and ABGII Hip Implant Recipients Beware: The Stryker PER Letter and What it could mean for You

strykerIt appears that some recipients of the Stryker Rejuvenate or Stryker ABGII hip implant may have received a Product Experience Report or “PER” Letter from Stryker Orthopedics in response to either the patient, or the patient’s doctor, or even the patient’s treatment facility notifying Stryker of any issues with a specific implant. Although these letters appear on their face to be fairly innocuous (simply thanking the patient or doctor for the submission of their Stryker hip implant issues and indicating they will be putting together a PER for the patient), there are serious issues to consider. Stryker requests that the patient grant them permission to obtain all of the patient’s medical records so they can more fully conduct their investigation of the issue.

Another Broadspire Letter in the Works?

Although Stryker is not offering to pay for revision surgery at this point, is not asking patients to waive their rights to future recovery and is not requesting that any removed implants be turned over to them, there are other potential issues at hand. First and foremost, by allowing Stryker access to your highly personal medical records, not only can they label you a potential claimant, they could conceivably blame the failure of your Stryker hip implant on any number of things found in your medical history.

When DePuy issued the recall of their ASR hip implant, they contracted with a company called Broadspire to send out a letter to ASR hip implant recipients which essentially offered to pay for revision surgery for those “qualified” patients. In return, the patient may waive future rights of recovery and allow DePuy access to removed ASR implants. Unfortunately, some of these patients found later on that DePuy claimed their hip implant issues were not hip implant issues at all, but were rather related to other health problems rather than the hip implant itself.

Recall of the Stryker Rejuvenate and Stryker ABGII Hip Implants

As a bit of background information regarding the Stryker ABGII and the Rejuvenate, both hip implants were recalled this past July, less than four years after receiving FDA approval. The Rejuvenate was approved first, in June of 2008, then the ABGII later in November of 2009. Both implants were considered very innovative due to the two-piece modular neck and stem which allowed surgeons much more freedom in choosing the best size for individual patients.  The idea behind the newer design was that by using a ceramic head, there would be no metal ion shear like that found in other metal-on-metal designs.

Corrosion Leading to Potential Metallosis

Later, however, it was found that there was a significant risk of corrosion at the neck juncture which could lead to metal ions being released into the body, and the company listed this risk as a reason for the recall. In addition to neck juncture corrosion, the small metal trunnion found at either end of the neck piece which allowed the components to snap together were found to result in corrosion when body fluids became trapped beneath. Although the level of metal ions being released into the body is unlikely to be as great as those in the all-metal hip implants, there are very real risks from any level of cobalt and chromium being introduced into the body.


Results of Cobalt and Chromium

When the corrosion occurs and the microscopic ions of cobalt and chromium are released into the body, they will either become lodged in surrounding tissues or enter the bloodstream. When the metals burrow into tissues, the body, sensing a foreign substance, sends white blood cells to fight the onslaught. The surrounding tissues will become inflamed, cause significant pain to the implant recipient, and, eventually, tissue death and bone loss can occur, causing the implant to fail completely. Once an implant loosens or fails due to these tiny metal shards, revision surgery becomes necessary.

When the metals enter into the bloodstream, a wide variety of serious medical issues can result. Neurological, renal, cardiovascular and thyroid issues can occur, and, in some cases, DNA disruption can take place. Memory loss, loss of vision or hearing, gastrointestinal disorders, skin disorders, Pseudo-tumors and balance issues can also be a result of cobalt and chromium poisoning, and the effects are not easily reversible, even once the implant is removed. As of this juncture, the FDA has received over 60 reports of Stryker hip implant problems or failures regarding the ABGII or Rejuvenate and many of those devices failed within eighteen months of implantation.

DePuy’s Former CEO Now Working For Stryker

Should you have received a PER letter from Stryker, there is yet another fact to consider: David Floyd, former CEO of DePuy during the recall of the ASR which has amassed tremendous legal fees for the company thus far, is now, according to the Houston Chronicle, working for Stryker as head of Stryker’s orthopedic unit. Between working for DePuy and working for Stryker, Floyd worked briefly for Ortho Workx, an initiative aimed at boosting the orthopedic sector. Many DePuy ASR implant recipients trustingly waived their right to recovery away when they received the Broadspire letter, believing DePuy intended to do the right thing and take care of their expenses for revision surgery. Unfortunately, that was not always the case.

How Stryker Could Use their PER Letter

Many DePuy ASR hip implant recipients found that once they released their medical records and waived their right to recovery, DePuy found they were not entitled to reimbursement for revision surgery or other medical issues related to the implant. The health problems experienced by the implant recipients were blamed on such things as being overweight, being extremely active, or suffering a prior injury. While Stryker’s PER letter seems fairly harmless, a letter similar to DePuy’s Broadspire letter could certainly be in the works considering David Floyd is now working for Stryker. There is no third party oversight involved in the PER letter which means Stryker is free to reply simply with a “best assessment” of the performance of their Rejuvenate and ABGII implants.

Using Caution When You’ve Received a PER Letter

In any case, releasing your medical records to the company means those records stand a very real chance of being used against you in the event of a future lawsuit and Stryker will have gained a serious advantage over you. It is important to think carefully before signing a PER requested “Authorization to Use or Disclose Health Information” and agreeing to release your medical records to Stryker. Remember that revision surgery for the Rejuvenate and ABGII are considered much riskier than for other metal-on-metal implants. The stem of Stryker’s recalled implant is buried deeply within the femoral bone therefore when a surgeon must remove it, there is a very real risk of the femur fracturing or even shattering. The operating time is considerably longer as is the recovery time following the surgery. Revision surgery can result in huge medical expenses as well as time away from work. Don’t jeopardize your entitlement to compensation.
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Author: Andrew Sullo
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