The human body has a remarkable ability to heal itself. From scabs that form over cuts as new skin grows, to bones that fuse after breaks, to immune responses that fight off infection, our bodies frequently have the capacity to fix damage done to them. Some bodily damage is so severe that surgical intervention, including temporary or permanent medical device implants, may be required to assist the body’s healing natural process.
Surgical implants are usually defined as medical devices manufactured from metals, plastics, ceramics, and biomaterials in contrast to transplants which use biomedical materials (living tissues, organs and bone grafts). Surgical implants can provide support to existing tissue and organs, act as prosthetics (replacement body parts), deliver medication, or monitor body functions.
Although they are created to help a human body in some way, the body itself frequently rejects a surgical implant's presence. Any foreign object in the body can trigger a natural immune response design to break it down and/or expel it from the body. When designing and testing surgical implants, medical device manufacturers must therefore carefully examine how the body reacts and whether alternative materials or designs may offer the same benefits with less risk to a person’s health. Unfortunately, not all surgical implants are tested as rigorously as they should be, and they may end up failing, malfunctioning, or causing serious collateral damage to the body.
Estimated to be a $400-billion industry, medical device manufacturers may feel intense pressure to introduce surgical implants to the market before longer-term clinical trials are completed. In some cases, surgical implants were approved for use in humans when the only product testing completed had been done on animals and human cadavers.
A defective surgical implant may cause serious injuries, permanent disability or death. Remediation or removal surgeries disrupt lives and put a patient at risk of post-surgery infection or complications for a procedure they would likely not have needed if the surgical implant was properly designed, manufactured and/or tested.
If you or a loved one have experienced serious health issues you believe may be linked to your surgical implant, have an implant that has been the subject of a recall notice, or have required surgery to remove, replace or otherwise fix the implant, you may be eligible for compensation for your injuries and losses. Gluckstein Personal Injury Lawyers’ surgical implant team is ready to listen to your story, answer your questions, and offer options for how you and your loved ones can move forward.
Examples of surgical implants.
Whether they are intended for cosmetic purposes, to monitor body functions, to deliver medications, as replacement body parts, or to provide some form of support to existing tissue, bone or organs, surgical implants have been designed for many different parts of the body. Examples of some common surgical implants include the following devices:
- cardioverter defibrillators and pacemakers detect and stop irregular heart beats or provide an electrical current to restart a heart if a person experiences a cardiac arrest.
- coronary stents are tubes which supply blood to the heart and keep arteries open in patients with heart disease.
- insulin pumps provide timed and measured doses of insulin for diabetics.
- gastric stimulators provide electrical stimulation to the stomach to assist in weight loss or gastroparesis.
- artificial hip, knee, shoulder, elbow, wrist, finger and toe joints replace broken, worn or otherwise deteriorating joints in the body.
- phakic intraocular lenses are plastic or silicone inserts which permanently eliminate the need for glasses or contact lenses.
- breast implants are used to augment existing breast tissue or to replace breast tissue that has been removed as a preventative measure or as a treatment for disease such as cancer.
- penile implants are semi rigid or inflatable devices designed to assist men experiencing erectile dysfunction.
- cerebral spinal fluid shunt systems are used to treat hydrocephalus by draining excess fluid from the brain and moving it to a part of the body where it can be absorbed through the circulatory process.
- metal screws, rods, pins and plates are often used temporarily or permanently to strengthen, replace or secure other devices to bones.
- artificial discs replace spinal discs that have deteriorated or been damaged by trauma.
- intrauterine devices offer temporary or permanent birth control by blocking pathways in the uterus or fallopian tubes necessary for conception.
- cochlear implants are devices designed to provide a sense of sound to the severely hard of hearing or profoundly deaf.
- hernia and trans-vaginal mesh are net-like implants used to treat pelvic organ prolapse or urinary incontinence.
The surgical implants approval and monitoring process.
When manufacturers apply for approval to bring medical device implants to the market they must meet certain requirements and provide evidence to demonstrate their product is not unreasonably dangerous, that known or potential health and safety risks have been mitigated, and that the product’s net benefits outweigh its risks. The amount and type of information required by Health Canada depends on the class of medical device (assigned based on risk of use). Manufacturers will often supply data from their own clinical trials and/or post-market data if the device has previously been approved for use in another country.
Once approved, Health Canada conducts post-market inspections and monitoring. Recent changes to medical device laws mandate that hospitals and healthcare facilities must report serious incidents to the ministry. However, manufacturers remain primarily responsible for reporting incidents involving their surgical implants. To determine whether an incident is reportable, Health Canada states it must meet the following three criteria:
- an incident occurs - the incident may be a malfunction or failure of an implant in real world use or information from device testing performed by the manufacturer, user or other party.
- the device caused or contributed to the incident - when assessing the link, manufacturers should err on the side of caution if there is uncertainty and/or if there are multiple devices and/or drugs involved. The opinion about the link should be based on available information from a health professional, information about previous or similar incidents, complaint trends, and any other pertinent information.
- the incident leads to one of these outcomes - the death of a patient, user or other person; serious deterioration in the state of health of a patient, user or other person; or the potential for death or serious deterioration in health of a patient, user or other person.
When you’ve been hurt.
Although the government has introduced recent changes to strengthen the surgical implant approvals and monitoring process, medical device defects will continue to seriously hurt or kill some people. Implants which received approval prior to these more stringent regulations remain in thousands of people and some defects only become apparent after years of use.
If you or a loved one have experienced unexpected, adverse medical outcomes you believe may be linked to a surgical implant, or if you’ve received notice of a recall involving these implants that requires you to have unanticipated remediation surgery or removal surgery, you may be eligible for compensation for your losses.
Gluckstein Personal Injury Lawyers has developed a team of knowledgeable, skilled and experienced medical product liability lawyers available to assist people with actionable claims against manufacturers, regulators, and other people involved in approving and distributing defective surgical implants. Consistently ranked as one of Canada’s top personal injury firms by our peers in the legal sector, we have a strong record of getting results for our clients.
How we can help.
When you call us for your free, no obligation initial consultation, we’ll attentively and compassionately listen to your story. After explaining your legal rights, our team can outline some of your options for seeking justice and a sense of closure. If we believe we can negotiate fair financial compensation for your claim or win a court judgement in your favour, we will offer to become your trusted legal representative and tireless advocate.
With our extensive network of medical experts and experienced medical device liability lawyers, we can handle even the most complex and challenging cases. Our confidence in our ability to assist our clients means we will not ask you to pay any legal fees or expenses for our services unless we are successful in bringing you monetary compensation.
As a firm renowned for our commitment to full-circle client care, you are never just a case number to us. We treat our clients as we would treat our own family and continue to care about your well-being long after legal proceedings end.
Learning that something surgically implanted in your body could harm your health, cause permanent disability or even result in death is unimaginably distressing. You should know you do not have to face your fight for fair compensation alone. Choose Gluckstein Lawyers to join you on your journey as you seek justice for what’s been done to you. Together, we can work to give you hope there are better days ahead.
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