Injuries caused by medical implants result in personal injury cases for which medical chart reviews are an important consideration. While medical implants have many advantages, and can restore flexibility and mobility to people who suffer from health conditions such as arthritis or have experienced a debilitating injury, they can cause considerable harm if they are defective or if the surgeon makes a serious mistake during the implant procedure. Artificial knees, hips, and shoulders are now replacing deteriorated joints. Pacemakers, stents, and lab-bands are extending life. Ocular and dental implants help people enjoy life more. The global medical implant industry exceeds $200 billion, and it is estimated that almost 20% of all adults have received an implant of some type.
An important concern is the quality and reliability of these medical implants. Poor device quality is a reality, and has paved the way to a number of lawsuits. New drugs are tested and approved to ensure their safety and effectiveness. However, medical implants are not required to undergo clinical trials. Many of these devices are designed to be implanted and last ten or even more years, while the safety testing measures are inadequate. In fact, most medical implants are approved on the basis of “substantial equivalence,” via the FDA’s 510 (k) protocol. This means that if an implant is substantially equivalent to an implant already on the market, it may be easily approved. Under the 510 (k) protocol, medical device makers need only file paperwork and pay a fee to federal regulators.
The most common medical devices associated with injuries are the following.
- Hip implants: A large number of people with advanced arthritis go for total hip replacements each year, which involves surgically replacing the hip joint with a prosthetic. Johnson & Johnson’s DePuy Orthopaedics’ hip implant with a new all-metal design got FDA clearance via the 510 (k) process. The device proved dangerous, because the metal eroded releasing metallic particles into the blood and surrounding tissue of the joint, causing excruciating pain. The British Hip Society estimates that the failure rate of the DePuy implant was so high that almost half of all patients who got the implant required surgery within 6 years to fix problems. This implant was recalled in 2010, but by then almost 100,000 people had already received it.
- Surgical mesh: Transvaginal surgical meshes for prolapsed repair and bladder support came on the market in the early 2000s. The mesh was packaged in a “kit” with tools for insertion and marketed to doctors as an easier way to do a surgery that traditionally required special additional training. However, this device has proved disastrous to many women, who experienced complications ranging from chronic and constant vaginal pain, vaginal bleeding, inability to sit for more than an hour at a time, inflammatory reactions, incontinence, hemorrhages and leg weakness among others. “Erosions” were another issue, caused when the product enters surrounding tissue, protrudes out of a body structure or tissue and into surrounding organs causing holes and hemorrhaging. These meshes were also cleared on the basis of their “substantial equivalence” feature. A study in the journal Obstetrics and Gynecology found that 15 percent of women treated with vaginal mesh had complications. Boston Scientific recalled its surgical mesh called ProteGen Sling in 1999, following numerous complaints of infections, injuries, and pain. More than ten years after this, Johnson & Johnson faced hundreds of lawsuits over a surgical mesh device that was very similar to the ProtoGen Sling. It was only in July 2011 that the FDA admitted that serious complications with mesh are not rare, and may expose patients to more risk, and in January 2012 ordered manufacturers to conduct studies of surgical mesh.
- Breast implants: These medical implants have been associated with the development of a rare type of non-Hodgkin’s lymphoma known as anaplastic large cell lymphoma or ALCL. The FDA agrees with the WHO’s designation of breast implant-associated (BIA) anaplastic large cell lymphoma or BIA-ALCL as a rare T-cell lymphoma that may develop following breast implants. In 359 reported cases of cancer, 231 included information about the implant surface, 203 were textured implants, and 28 were smooth implants. Among the 312 cases wherein the implant’s contents were known, 186 were filled with silicone gel and 126 with saline. There have been deaths associated with the cancer.
What can be the reasons for such implant failures?
- Most companies manufacturing these devices focus on profit, though they claim that their primary responsibility is towards their patients. As such, they may bring implants to market quickly and aim at selling as many as possible since there is no requirement for an expensive clinical trial.
- Another reason is that the regulators guided by the government work with industry leaders to bring innovative medical implants to the market with a view to benefit patients as well as manufacturers. If the lean is towards the industry, the regulator could end up advancing the concerns of the industry it is charged with regulating. Moreover, “innovative” implants may be given a patent more easily.
- There is a lack of transparency regarding the approval process. For instance, if the implant was approved in the EU, the information is confidential and it becomes difficult to evaluate how an implant was tested and what the test results were.
So how can the concerns related to medical implants be addressed effectively? The Consumers Union, the advocacy arm of Consumer Reports puts forth the following recommendations.
- Must require that implants and other life-sustaining medical devices are tested as rigorously as drugs.
- Create a unique identifier system or IDS for implants, to enable patients to be quickly notified about recalls and safety problems.
- Create national registries to spot problems quickly and notify patients.
- Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
- End the practice of “grandfathering” high risk new implants and life-sustaining devices.
Other ways of ensuring safe medical implants include undertaking phased introduction of new medical implants at specialist centers where all details of the implants and the procedures are fully tracked. The implant could be introduced to the larger section of the public once its efficacy is shown after a certain amount of time. Patient safety should be the priority of regulators.
Meanwhile patients hurt or injured by a medical implant should be careful when deciding to sign any document releasing the manufacturer from liability, in an attempt to reach some sort of financial settlement. If the document is signed, the patient cannot pursue further compensation and will be foregoing any further legal recourse. As providers of medical record review for attorneys handling product liability and personal injury cases, we understand the importance of medical implant testing before making it available to patients. All medical devices must be put through all testing and validation before they are released to the market.