The healthcare industry in this country is in perpetual conflict with itself. On the one hand, it exists to help people when they are sick or injured, or in a vulnerable position. On the other, it exists to generate money.
And it generates a lot of money. In 2021 alone, healthcare spending accounted for 18.3% of the country’s Gross Domestic Product (GDP) – about $4.3 trillion dollars, or $12,914 per person. This doesn’t account for over-the-counter medications and products, like pain relievers or bandages.
The pursuit of financial gains has incentivized hospitals, surgical facilities, and practices (private or otherwise) the adoption of new medical devices or drugs that lack comprehensive clinical validation, as manufacturers strive to capitalize on market demand. As attorneys handling both product liability and medical malpractice claims throughout Georgia, we have seen first-hand just how dangerous this can be.
What you should know about atherectomies
A recent New York Times article has shed light on a growing industry that provides potentially risky treatments to millions of Americans dealing with peripheral artery disease (PAD), a condition characterized by plaque buildup in leg arteries. Dr. Jihad Mustapha, a central figure in this field, operates multiple vascular clinics and collaborates with medical device manufacturers like Philips. Despite evidence showing that many PAD patients could be effectively managed with medication and lifestyle changes, this industry encourages procedures like atherectomies, which utilize wires or lasers to remove plaque.
These interventions can be expensive and may not provide significant benefits to patients. The surge in these procedures is likely attributed to changes in Medicare payments and financial incentives from device manufacturers. This lack of strict regulation enables doctors to profit from procedures that might not be necessary, putting patients at risk and generating substantial revenue. Despite concerns about complications and amputations linked to such interventions, financial support from device manufacturers persists, raising questions about the appropriateness and necessity of these expensive procedures and medical devices.
Do these medical devices actually work?
The vascular industry operates within a realm of limited oversight. Numerous medical devices navigate the Food and Drug Administration’s (FDAs) clearance process with minimal supporting data on their efficacy. Clinics operating within this industry are not held to the same safety standards as hospitals. Regulatory bodies often levy modest fines and allow doctors to continue practicing, even when unnecessary procedures are identified.
Originating in the 1980s, atherectomy devices were initially created to alleviate arterial blockages, a purpose that even back then was marked by controversy. Doubts regarding their safety and efficacy emerged through studies, particularly in relation to their application in heart treatments.
Subsequently, these devices found their way into the market for treating leg blockages, spearheaded by various companies. The FDA maintains a relatively low threshold for authorizing atherectomy tools and other medical devices. Essentially, companies need to demonstrate to the FDA that their devices are akin to those already in existence, a criteria that facilitates their approval process.
What is the FDA’s device approval process?
The 510(k) FDA approval process for medical devices has long been a topic of debate due to its relatively lenient standards. Under this pathway, a medical device can gain clearance for market entry if it can be demonstrated that the device is substantially equivalent to a device already legally marketed (a “predicate device”). This process aims to expedite the approval of new devices by leveraging the similarities with existing ones.
However, critics argue that the 510(k) process has significant drawbacks. One major concern is that it allows new devices to be approved based on their resemblance to older devices that might not have undergone rigorous scrutiny themselves. This creates a situation where a chain of devices can be approved with minimal original clinical data, leading to a potential accumulation of suboptimal or unsafe devices over time.
Furthermore, the 510(k) process doesn’t always require comprehensive clinical trials for the new devices. Instead, manufacturers often rely on lab testing and simulations, which might not accurately reflect real-world usage or potential complications. This lack of robust clinical evidence can raise questions about the safety and effectiveness of newly approved devices.
In an article published by the National Library of Medicine, research findings showed that a “study using the FDA’s 510(k) and PMA medical device database, 28,556 devices were reviewed. Although 97% of recalled devices had received 510(k) clearance, devices with PMA had 2.7 times the hazard of recall and 7.3 times the hazard of high-risk recall compared with devices with 510(k) clearance.”
This meant “that, despite the requirement of clinical trials, high-risk devices approved via PMA were associated with greater safety concerns than previously reported; in addition, most recalls are for 510(k) devices, raising safety issues.”
The relatively low standards of the 510(k) FDA approval process have led to concerns about patient safety and the quality of medical devices in the market. Critics argue that more stringent criteria, especially for devices with higher risk profiles, could help ensure that only devices with proven safety and efficacy are allowed to reach the hands of medical practitioners and patients.
What is peripheral artery disease?
According to the Centers for Disease Control and Prevention (CDC), Peripheral Artery Disease (PAD) is a vascular condition that affects the arteries outside of the heart and brain, primarily those supplying blood to the limbs, most commonly the legs. It’s a form of atherosclerosis, which is the buildup of plaque within the arteries. In PAD, this plaque buildup narrows and stiffens the arteries, reducing blood flow to the limbs. This decreased blood flow can lead to a range of symptoms and complications.
Symptoms of PAD can vary but often include pain, cramping, or discomfort in the legs, thighs, or buttocks during physical activity. This pain, known as claudication, typically subsides with rest. As the condition progresses, pain might occur even at rest or while sleeping. In severe cases, PAD can lead to tissue damage, ulcers, and even gangrene, which might necessitate amputation.
PAD is often linked to other cardiovascular risk factors, such as smoking, high blood pressure, high cholesterol, diabetes, and obesity. These risk factors contribute to the development of atherosclerosis, which is a key factor in the development of PAD.
Diagnosis of PAD involves various methods, including physical examinations, medical history assessment, and non-invasive tests like the ankle-brachial index (ABI) to measure blood pressure in the legs. Imaging techniques like ultrasound, angiography, and magnetic resonance angiography might also be employed to visualize the blood vessels and assess blood flow.
Treatment of PAD aims to alleviate symptoms, slow disease progression, and reduce the risk of complications. Lifestyle modifications such as smoking cessation, regular exercise, a healthy diet, and managing underlying health conditions like diabetes are fundamental. Medications can be prescribed to manage symptoms, control risk factors, and prevent blood clots.
In more severe cases, procedures might be necessary. Angioplasty involves inflating a small balloon within the narrowed artery to widen it and improve blood flow. Stent placement can also be done during angioplasty to help keep the artery open. In advanced cases, bypass surgery might be considered to reroute blood flow around the blocked artery.
Early diagnosis and comprehensive management are essential in mitigating the impact of PAD. Regular check-ups, especially for individuals with risk factors, can help identify the condition before it becomes severe. Maintaining a healthy lifestyle and following medical advice are crucial steps in managing PAD and reducing its impact on overall health and quality of life.
PAD and amputation
PAD can ultimately lead to the serious and concerning complication of amputation. This progression occurs due to the gradual narrowing and blockage of arteries that supply blood to the limbs, typically the legs. As PAD advances, the reduced blood flow limits the delivery of oxygen and nutrients to the muscles and tissues, leading to a condition known as critical limb ischemia (CLI).
CLI is characterized by severe pain, non-healing ulcers, and tissue damage in the affected limb. Without adequate blood flow, the tissues become deprived of vital nutrients and oxygen, which are necessary for cell survival and healing. As a result, even minor injuries or cuts on the foot or leg can develop into non-healing wounds that are susceptible to infection. If these wounds progress and infections worsen, tissue necrosis (cell death) can occur, leading to gangrene.
Gangrene is a grave condition where a significant portion of tissue dies due to lack of blood flow and infection. In cases of severe gangrene that cannot be successfully treated with antibiotics, surgical intervention is often required to prevent the spread of infection to other parts of the body. Unfortunately, in many instances, amputation might be the only viable option to save the patient’s life and prevent the infection from becoming life-threatening.
Early detection, timely medical intervention, and effective management of PAD to prevent the progression of the disease is critical to mitigate the risk of amputation.
If you’ve received a diagnosis of PAD and are confronted with the potential of amputation, enlisting the assistance of a Harris Lowry Manton LLP attorney can be a pivotal step. Our seasoned personal injury lawyers with experience in medical cases can offer indispensable guidance during this trying time. They possess the legal acumen to dissect your situation comprehensively, evaluating if medical negligence, subpar treatment, or inadequate care played a role in your PAD-related complications. By delving into the intricate details of your case, our attorneys can construct a robust legal strategy, leveraging their investigative skills and collaboration with medical experts to pinpoint any negligence or errors that contributed to your circumstances.
This steadfast advocacy extends to negotiations with insurance entities, healthcare providers, and relevant parties, ensuring you receive a just award that encompasses medical expenses, future care necessities, pain and suffering, and any other pertinent damages. In the unfortunate event that an award is not attainable outside the courtroom, our legal team is equipped to adeptly represent your interests during litigation proceedings, offering both legal and emotional support as you navigate the complexities of seeking compensation and justice in the face of amputation due to PAD-related challenges. To schedule a free consultation, call us in Savannah or use our contact page.
Steve Lowry is an award-winning litigator who has secured record-setting jury verdicts on behalf of his clients. A passionate advocate for individuals who have been harmed by the actions of others, Steve has won numerous top 10 verdicts in Georgia.
Read more about Stephen G. Lowry here.