Bone growth/spinal fusion stimulators are a supplement form of therapy designed to help enhance the bone’s natural healing process. This process is highly important in ensuring that spinal fusion surgery is successful. However, several implantable spinal fusion stimulators have been recalled due to high risks to patients. In November 2018, Zimmer Biomet recalled 1,360 Zimmer Bone Growth Stimulators units on the risk that they could be contaminated with chemicals or bacteria. The Food and Drug Administration (FDA) gave this recall a Class I status.
The Class I Recall of Zimmer Bone Growth Stimulators was given because there is a reasonable possibility that the use of implantable bone growth stimulators is linked to severe adverse health consequences or death. The recall covers devices manufactured and distributed between February 2015 and March 2017. Problems with the Zimmer Bone Growth stimulator largely involve a lack of validation and quality control. According to the FDA, this can cause adverse bacterial infections that can turn out to be fatal. This Recall was more of an expansion of an earlier warning given to Zimmer Biomet - the manufacturer. A year before the recall, the FDA officials were aware of the risks associated with the Zimmer bone growth stimulator.
What is the Zimmer Bone Growth Stimulator?
A bone growth stimulator is a medical device that helps in bone regrowth. It is a supplemental type of therapy that is valuable to physicians and patients when it comes to recovery from spinal fusion surgery. A person undergoes spinal fusion surgery when movement causes severe pain, and the patient has no other options. Since bone is a living tissue just like muscle and skin, it will heal itself when injured or broken if provided with the right conditions and stimulation.
The bone growth stimulator is a small device implanted in a soft pocket of tissue in the lower back and to the side of the spine. Bone fragments are directly placed between vertebrae bones that are to be fused. The process of osteogenesis begins once the surgery is completed. Osteogenesis refers to the process by which the body grows back bony tissues. The Zimmer bone growth stimulator is intended to be in place for several months, usually 6-12 months. A bone growth stimulator is designed to aid the process and heightens the body’s healing process. The spinal connection process is encouraged by electrical charges applied to the surgical area to help the body grow bone tissue quicker. A bone growth stimulator may be used with or without other devices designed to help with the fusion. This process is expected to restore a patient’s spine together with all the important functions attached to the bone.
Given that spinal fusion surgery is major surgery, doctors only recommend this to patients when there is absolutely no other option available. Patients who may be more suitable for a bone growth stimulator are those who are having a multi-level spinal fusion or have previously had a failed spinal fusion. Furthermore, patients suffering from vascular disease, osteoporosis, obesity, renal disease, diabetes, and alcoholism may be at greater risk for needing a bone regrowth/spinal fusion stimulator.
However, Zimmer Biomet discovered that some of its devices had dangerous toxic chemicals, placing them at risk for causing potentially fatal complications for patients. According to the FDA reports, Biomet bone growth stimulator contains higher levels of toxic chemicals, which may cause tissue and organ damage. These harmful chemicals may cause toxicity known as Cytotoxicity, which may cause toxicity in tissues and organs. Biomet spinal fusion stimulator side effects may as well include paralysis, additional surgeries, chronic infections, and in some cases, death.
In 2017, the FDA started receiving complaints from patients who used the Zimmer bone growth device and experienced severe infections. Instead of taking action to correct the situation, the FDA did nothing. Instead, the agency allowed the manufacturer to issue a voluntary recall in February 2018. Re-inspection of the bone growth stimulator production facility exposed the company’s unwillingness to correct the flaws in the manufacturing process. Zimmer Biomet officials promised further corrective action that just never materialized.
Zimmer Bone Growth Stimulator 2017 Recall
On April 20, 2017, the FDA indicated that Zimmer Biomet had sent an “Urgent Medical Device Removal” notification to all individuals affected by the device. Zimmer customers were instructed:
- To isolate all affected recalled products
- Review notifications and convey the information to all necessary personnel.
- Return the form by fax or email to the manufacturer
- Zimmer Biomet sales reps were required to remove the defective devices from the facility. Customers who purchased the device directly from Zimmer are to follow the instructions on the “Certificate of Acknowledgement” form provided by Zimmer in order to return the device
- Surgeons were advised to monitor patients 3-6 months postoperatively for any person who has been implanted with SpF XL IIB or SpF PLUS-Mini Implantable Spinal Fusion Stimulators
According to the manufacturer, SpF XL IIB or SpF PLUS-Mini Spinal Fusion Stimulators provide what is described as an Adjunctive Treatment for Lumbar Spine Fusions. As indicated on Zimmer’s website, more than 100,000 devices have been implanted and are meant to improve fusion success rates. The devices are designed to offer a constant dose of electrical stimulation for at least 6 months.
The reason for the 2017 recall was due to the devices’ failed cytotoxicity test, which measures a devices’ compatibility with a human body. This test is part of the biological evaluation done to all medical devices before they’re approved by the FDA. The Zimmer bone growth stimulators had a positive cytotoxicity test, which indicated that the devices contain potentially harmful chemicals at levels that could be dangerous to the patient. When released, the chemicals can be toxic to organs and tissues in the human body. Cytotoxicity can cause infections and long-term hospitalization as a result of paralysis, revision surgeries, and death. For this reason, the FDA labeled this as a Class I Recall, which is only reserved for products that could cause serious complications or death. The recall affected 33 serial numbers for devices manufactured between October 11, 2016, and January 18, 2017, and distributed between March 28, 2017, and April 6, 2017.
2018 Recall of Zimmer Bone Growth Stimulators
More than 1,360 Zimmer implantable bone growth stimulators were recalled on the risk that they could be contaminated with chemicals or bacteria. The Class I recall covers devices manufactured between February 2015 and April 2017 and distributed between April 2015 and March 2018. Devices recalled include the:
- SpF PLUS-Mini Implantable Spinal Fusion Stimulator
- EBI OsteoGen Implantable Bone Growth Stimulator
- SpF-XL IIb Implantable Spinal Fusion Stimulator
According to the FDA, the voluntary recall was mainly due to the lack of sufficient validation and controls to make sure that end products were not only clean but free from chemical residues and bacteria. The FDA warned that the lack of adequate validation and controls may or may not cause severe side effected for the patient including tissue death, infection, additional surgery for wound treatment and/or device removal, the need for long-term antibiotic, impaired wound, and bone healing, swelling and infection around spinal cord, the potential for secondary gastroenteritis, damage to other organs or death.
The agency inspected the North Campus plant in Warsaw in 2016, detailing several violations. In a lengthy response that December, Zimmer Biomet documented its action plan in amending the issue, highlighting that company-wide audits put in place. Zimmer stated that it cleaned house immediately after the inspection, substituting 5 operations and quality executives in its move to revive the facility back into compliance.
However, a re-inspection carried in April 2018, revealed significant violations of the quality system regulations, including failure to show that its process for corrective and preventive actions can make sure that the plant attains finished product specifications and the lack of adequate training procedures. Furthermore, the inspecting officers also discovered problems with the Northern Campus facility’s design validation process, its CAPA implementation, and its handling of non-conformance, in accordance with the warning letter.
In a May 2017 letter, Zimmer Biomet provided the following instructions to different groups of customers:
- Distributors to isolate any products in inventory and send them back to Zimmer Biomet. They should also identify all consignees with the product so as to reconcile all remaining product
- Hospital risk managers to set aside any recalled device for a distributor or sales representative pick-ups
- Consignees to inform affected members of the recall and return an acknowledgment of responsibilities
- Surgeons to continue monitoring patients with devices that fall into the recalled categories
Zimmer Bone Growth Stimulator Side Effects
A contaminated spinal fusion stimulator can give rise to a wide array of health issues for patients receiving therapy. Some of the common side effects for chemical or bacterial contamination include:
- Tissue death
- Surgery for device removal
- Additional surgery for wound treatment
- Impaired wound and bone healing
- Secondary gastroenteritis
- Long-term antibiotic therapy
- Organ Damage
- Infections around the spinal cord (epidural abscess)
- Swelling around the spinal cord
Unfortunately, though the device has been recalled, some patients may not yet know that the health problems they are experiencing are caused by the Zimmer Bone Growth Stimulator. If the defective device is not removed, it may cause additional injury. Some injuries may already have occurred during the treatment period.
Zimmer Bone Growth/Spinal Fusion Stimulator Revision Surgery
A spinal fusion stimulator is designed to work within 6 months to 1 year, but with the poor manufacturing quality controls, a majority of patients will require a second surgery after the original one. This is considered an adverse event related to the bone growth stimulator itself. Revision surgery poses a greater risk to patients because it is usually more invasive for the surgeon to perform, and may require procedures to reconstruct the damaged area. Revision surgery is more costly and invasive and usually requires a much longer recovery and rehabilitation period. Patients who have experienced premature failure of the stimulator or cytotoxicity may file lawsuits against the manufacturer.
Bacterial Infections Linked to Medical devices
When it comes to sporadic bacterial infections, a person cannot do much about the condition. In some cases, device makers may not be responsible for damages because infections may be directly associated with surgical procedures and not the device. However, a chronic lack of oversight is a completely different case. If a defective device is put on the market, individuals have harmed a result, and the manufacturer does not take any steps to remedy the situations, the manufacturer may be held accountable for the infections.
The bacterial infections resulting from a lack of control can cause severe and deadly conditions. The number of new antimicrobial agents has been on the decline over the years, and resistance to antibiotics has increased significantly. Moreover, bacteria that accumulate in the production stage may be 10,000 times tougher compared to bacteria that accumulate at the treatment stage. In general, the risk of infection increases with the complexity of the surface.
Dangerous Medical Devices and Claim for Damages
Medical device manufacturers are legally held to very high standards. Individuals implanted with these devices are generally already in poor health and prone to infection. However, many manufacturers take shortcuts as they rush to sell as many devices as possible. The shortcuts generally occur during the production stages, including:
- Design: Some medical devices suffer from design defects. Manufacturers have a duty to pinpoint these errors before the devices go into production and cause harm to consumers. For this reason, they are usually strictly responsible for any damages.
- Manufacturing: Other devices appear fine on the drawing board. However, a mistake in the production process renders the device hazardous. This mistake could be anything, such as a screw out of place.
Medical device manufacturers can also be held liable for damages caused by marketing defects. Typically, manufacturers have a duty to warn consumers about the risks associated with a device. This duty is discharged by warning healthcare practitioners about a dangerous product in accordance with the learned intermediary doctrine. The logic behind this doctrine is that a physician is the best position to understand the risks and benefits of a product and establish whether to use it on a patient.
Other cases also encompass negligence, which is typically a lack of ordinary care that results in damages. If it is proven that the device has a defect, you may be able to recover compensatory damages under a theory of negligence or strict liability. In a case involving strict liability, you may recover compensation by just showing that the device was defective, and you suffered harm as a result. Damages in both defective product and negligence cases, such as those involving Zimmer Bone Growth Stimulator, include restitution for economic losses, like medical bills, and non-economic losses, like pain and suffering. Furthermore, in many dangerous medical device cases, punitive damages are also available.
Moreover, if a loved one was implanted with a Zimmer bone growth stimulator and died as a result of toxic chemical exposure and fatal organ damage; you may be able to file a wrongful death claim against the manufacturer. In jurisdictions that require proof of negligence, the plaintiff must establish:
- The manufacturer’s duty of care,
- A breach of that duty,
- The breach caused injury, and
- Actual damages.
Funeral and burial costs may be available in a wrongful death case involving defective products.
Medical Device Manufacturers Put Profit over People
Medical device manufacturers have a duty to provide customers with safe products and warn consumers about the potential risks associated with their products. Zimmer has a duty to offer its customers safe products. If there are risks of harm linked to their devices, they also must provide proper warnings. If the manufacturer failed to do this, they should be held accountable for any injuries and the consequences of failing to warn about the risks they were aware of or should have known about. This is meant to ensure that doctors and patients can have an open and serious discussion about whether the medical device in question is the best option for the patient’s condition.
A patient may not be at ease, for instance, accepting a certain implant knowing very well that the side effects and complications may be fatal. Likewise, a patient may not wish his/her medical devices changed to another to manage their condition, knowing that the new device offers similar risks as the one he/she already has. However, many medical device manufacturers put profit over the wellbeing of consumers, resulting in severe injuries and damages. If you were harmed by the Zimmer Biomet Bone Growth Stimulator, you should hold the manufacturer liable for the harm.
Overview of Spinal Fusion Mass Torts
This is not the first time that Zimmer Biomet has recalled a product. The company has struggled with supply chain and quality control problems for some years, which have resulted in multiple recalls and thousands of lawsuits for the injury and losses cause by Zimmer devices. In 2016, for instance, Zimmer recalled its Comprehensive Reverse Shoulder, a shoulder implant meant to help restore arm movement. The company also recalled its Persona Total Knee Replacement in May 2019. The company also recalled its NexGen knee devices and the Durom Cup, a hip device.
Individuals sue over failed spinal fusion for several legal grounds. Below are some of the most common reasons for this type of lawsuit:
- A surgical implant’s defects were linked to its manufacture, design or marketing
- The manufacturing company was aware or should have been aware of the defects
- The surgeon was negligent while performing the surgery
- The manufacturing company did not warn its customers regarding the implant’s defect and potential harm.
- A surgical implant was placed into the market as safe and effective when the manufacturer knew very well that it was not.
The Zimmer Bone Growth Stimulator recall does not absolve the company of responsibility to patients. Patients who have been injured by the dangerous device or those who have to undergo revision surgery to replace the device may be eligible to receive financial compensation for the damages. Some manufacturers will try to contact affected patients to discuss their case and offer a small settlement. If the patient accepts the settlement, they waive their rights to get any additional help in the future. Patients who have used the Zimmer Bone Growth Stimulator should be aware of the recall but should also work with an attorney before agreeing to any settlement.
What to do if Your Spinal Fusion is Causing Problem
- Talk to your Doctor
As a spinal fusion patient, you undoubtedly are in close contact with your physician and can be able to rule out routine issues when they arise. Consulting with your physician is usually a good step because while something like back pain might be a sign of too much pressure on your spine; it could mean something else for your doctor. Just check with your doctor to ascertain it is not something serious.
- Talk to an Attorney
Every state has a statute of limitations, which is the time limit to file a legal claim. If you miss this deadline, you will no longer be eligible to file a claim. Some states allow one year for personal injury lawsuits; it is therefore important to do this as soon as you know that the device could be causing harm.
Find Help with a Zimmer Bone Growth Stimulator Mass Tort Near Me
If you or someone you know underwent spinal fusion surgery and suffered adverse consequences as a result of the Zimmer Bone Growth Stimulator, Consumer Alert Now can help you understand your options and get the legal help you need. It may be possible to become part of a mass tort. We can connect you with an attorney who can evaluate your case to determine whether you have a basis to bring a lawsuit against Zimmer Biomet. Call Consumer Alert Now anytime at 800-511-0747 or fill our online contact form for a free consultation. We provide our service to people all over the country.