Atherectomy is a medical procedure used to remove plaque from arteries, aimed at improving blood flow and preventing blockages. However, this technique has been linked to serious complications, including the need for limb amputation. Some medical professionals have even exploited the atherectomy procedure for financial gain, leading to unnecessary surgeries, legal battles, and patient suffering.
Written by :
Catherine Turner
Edited by :
Grace Johnson
HawkOne System Recall
Medtronic PLC recalled nearly 100,000 HawkOne Directional Atherectomy Systems after catheter tips broke during use, causing life-threatening complications. This recall, a result of 163 FDA complaints and 15 injuries, led to a Class I designation, signifying a high risk of serious health consequences or death from these peripheral artery-clearing devices.
Medtronic Bribery Allegation
Whistleblower Tom Schroeder from Beckton Dickinson initiated a lawsuit alleging Medtronic engaged in a bribery scheme at a Kansas veterans hospital, favoring its atherectomy devices. This resulted in unnecessary, dangerous procedures and about $5 million in yearly excess costs. Highlighted in a CNBC investigation, one egregious case involved a patient undergoing a procedure with 33 devices, showcasing severe medical imprudence.
Surge in Atherectomy Lawsuits
Investigations revealed a surge in malpractice lawsuits against doctors like Dr. Jihad Mustapha for unnecessary atherectomies, leading to patient harm and amputations. These doctors, exploiting mild artery disease cases, profited by overbilling Medicare and Medicaid, causing legal repercussions and spotlighting a troubling trend in healthcare malfeasance.
$25 Million Award in Philadelphia
Eddie Parks won a $25.9 million verdict against Temple University Hospital after a knee injury mismanagement led to his leg's amputation. A Philadelphia jury found the hospital and Parks' orthopedic surgeon liable for medical malpractice following a 39-day stay in 2018, resulting in significant legal and financial repercussions.
Government Incentives and Atherectomy Risks
A ProPublica investigation revealed that changes in Medicare's payment incentives since 2008 possibly spurred unnecessary atherectomies, with a 60% increase from 2011 to 2014. Payments for these procedures surged, implicating the top 5% of performing doctors in potential financial conflicts, resulting in $1 billion in government payments, and raising concerns over healthcare ethics. [1]
Atherectomy is a minimally invasive surgical procedure designed to remove atherosclerotic plaque from diseased arteries. It is primarily used to treat Peripheral Artery Disease (PAD), where plaque buildup leads to narrowed or blocked arteries, affecting blood flow.
The surgery involves small catheters equipped with cutting, shaving, or laser devices to clear the arterial blockage. Despite its effectiveness, atherectomy carries risks and potential complications.
Atherectomy procedures, while generally safe, can lead to several complications. The most common include bleeding at the catheter insertion site, arterial dissection, and embolization, where debris from the plaque can block other blood vessels.
More severe but less common complications are artery perforation and critical limb ischemia, leading to the need for amputation if not managed promptly.
These issues arise due to the mechanical nature of the procedure, patient-specific factors like the extent and hardness of the plaque, and the skill level of the operating physician. These complications not only extend hospital stays but also significantly impact the patient's quality of life and long-term health outcomes.
Atherectomy complications can range from minor issues to more serious conditions leading to amputation in severe cases. Navigating the legal aftermath of such devastating consequences can be challenging.
Explore your legal optionsPeripheral Artery Disease (PAD) is treated through lifestyle changes, medication, and various surgical procedures aimed at restoring blood flow to the affected limbs.
Treatment starts with managing risk factors like smoking, diabetes, and high blood pressure. Medications may include cholesterol-lowering drugs, blood pressure medications, and antiplatelet agents.
For more severe cases, surgical options like angioplasty, stenting, bypass surgery, and atherectomy are considered.
Atherectomy is unique in its ability to physically remove plaque, offering a beneficial option for cases where other methods might not be suitable, though it's important to weigh the procedure's benefits against its risks and long-term efficacy.
Atherectomy can be performed using different techniques, including directional, rotational, orbital, and laser atherectomy.
Each type has its own set of devices, like the SilverHawk for directional atherectomy or the Jetstream for rotational atherectomy.
These methods differ in their approach to plaque removal, suitability for different types of blockages, and specific risks, necessitating careful selection based on the patient’s condition and artery anatomy.
There have been many significant developments in the legal field concerning atherectomy, with cases that highlight the procedure's risks and the ensuing legal battles. These incidents cover a broad spectrum of issues, from medical malpractice to corporate misconduct, and offer a glimpse into the serious and often contentious nature of atherectomy in the medical field.
While it is a vital procedure for treating severe arterial blockages, atherectomy has come under scrutiny due to its association with some severe patient outcomes, including amputations. Such complications have sparked numerous lawsuits, underscoring the procedure's risks.
The legal battles associated with atherectomy often center on claims of negligence. Allegations typically point to the improper execution of the atherectomy procedure or a failure to provide the necessary patient monitoring and follow-up care.
The details of these incidents are typically uncovered in legal proceedings. Court documents and evidence presented at trial reveal the allegations and the procedural outcomes leading to severe complications, including permanent harm and amputations.
The outcomes of these legal challenges vary, with some culminating in substantial settlements or judgments favoring the plaintiffs, highlighting the essential need for strict medical protocol adherence and patient safety prioritization.
Among the many legal controversies, Medtronic, a leading manufacturer of atherectomy devices, stands out due to serious allegations. Accusations against the company assert unethical conduct, specifically that it bribed Veterans Affairs (VA) doctors to use their atherectomy products preferentially.
The allegations against Medtronic suggest that the company improperly influenced doctors at the Veterans Affairs (VA) to use their atherectomy products, leading to concerns about the fairness and honesty of medical decisions.
As a result of these accusations, the trust patients place in the healthcare system has decreased, and the public's view of Medtronic has worsened. These issues have also started wider discussions about the need for ethical behavior in healthcare.
Developed by Medtronic, HawkOne and TurboHawk are atherectomy devices used to remove plaque from arteries and enhance blood flow for patients with vascular diseases. These devices recently faced a recall due to malfunctioning issues, such as clogging, breakage, or a decline in operational effectiveness during procedures.
The malfunctions of the devices were primarily linked to the cutting mechanism, which, when less effective or non-functional, could result in inadequate plaque removal or, more severely, arterial damage.
Such malfunctions have raised concerns about the potential for patient harm, including the risk of injuries that might necessitate further surgical interventions to rectify the issues caused by these devices.
The decision to recall HawkOne and TurboHawk was driven by these safety concerns, highlighting the need for meticulous quality control and ongoing vigilance in the medical device sector to safeguard patient well-being during atherectomy treatments.
Another prominent controversy regarding atherectomy comes from a case in Michigan, where a doctor has been accused of conducting unnecessary amputations due to excessive and improperly executed atherectomy procedures.
In this case, the doctor allegedly performed a higher number of atherectomy interventions than medically necessary, often on patients who might not have required such invasive treatment.
The motivations behind these actions are suspected to be financially driven, with allegations suggesting that the doctor benefited monetarily from the increased number of procedures.
The case has sparked a significant outcry, leading to calls for more stringent checks within the healthcare system to prevent such abuses of medical practice and ensure patient safety and trust are upheld.
In a scenario reminiscent of Michigan's atherectomy-related issues, a Maryland physician faced allegations of performing unnecessary atherectomy procedures, leading to severe consequences like amputations.
Similar to the Michigan case, this physician is accused of excessively conducting these surgeries, often on patients without a clear medical need, primarily driven by financial incentives.
It's alleged that this approach resulted in significant financial gain for the physician, highlighting a problematic pattern across states. These actions have not only raised ethical concerns within the medical community but also sparked a broader debate on the need for stringent oversight to prevent such exploitation and ensure patient safety and trust.
There's an ongoing debate about how money affects medical decisions, especially when it comes to atherectomy. Many are concerned that doctors might perform this procedure more often than necessary because they are motivated by financial incentives rather than solely considering what's best for the patient's health.
The upsurge in atherectomy procedures in recent years can arguably be attributed to the profit-driven nature of modern healthcare. Financially, these procedures are highly rewarding for physicians and healthcare institutions due to favorable reimbursement policies.
Changes in healthcare billing and the incentivization of more lucrative, procedure-based practices have led to an increased focus on atherectomy as a preferred treatment option.
Studies and reports have highlighted how, particularly in the US, the healthcare payment structure has evolved in a way that procedures like atherectomy are more financially incentivized than less invasive, conservative treatments.
This shift has not only financial but also clinical implications, affecting decision-making processes and potentially leading to a preference for surgical interventions over alternative treatments, even in cases where the latter might be equally effective.
Doctors performing atherectomy procedures have seen their profits surge, with some earning millions of dollars. This financial gain raises concerns about the potential for conflicts of interest, where the decision to perform such procedures could be influenced more by personal gain than by patient health needs.
As public Medicare data reveals, a small number of doctors, mostly vascular surgeons, interventional radiologists, and cardiologists, have been responsible for a majority of atherectomies across the country.
A ProPublica study relying on public Medicare data reveals that, between 2017 and 2021, these doctors earned nearly $1.5 billion from almost 200,000 procedures. At the top of this list is a radiologist from Beverly Hills who earned almost double the reimbursements of any other doctor in America for over 7,000 atherectomy procedures. [2]
The escalation in atherectomy procedures driven by profit motives has led to increased risks for patients, including the dire consequences of amputations. The financial incentives for these high-cost procedures can lead to an overuse of atherectomy, sometimes in situations where it may not be clinically warranted.
This overuse has real-world consequences for patients, with reports indicating a rise in serious complications, such as unnecessary amputations, due to aggressive or inappropriate use of atherectomy. Patients, often unaware of the financial dynamics influencing their treatment, may be subjected to risky medical procedures that could have been avoided.
The ethical concerns in these cases are profound, highlighting a conflict between the financial interests of healthcare providers and the fundamental medical principle of "do no harm," necessitating a reevaluation of how patient care decisions are made in the context of financial gain.
While it can offer relief and improved blood flow for patients with artery disease, atherectomy can have potential risks and long-term effects that need to be carefully considered.
Recent studies have shed light on the concerning rates of amputation following outpatient atherectomy procedures. They reveal that while atherectomy can be effective in certain cases, there is a significant risk of severe complications, including the need for amputation.
For instance, research indicates that the amputation rate post-atherectomy can be alarmingly high, especially when the procedure is performed in an outpatient setting where patient monitoring and post-procedural care may be less comprehensive than in inpatient environments.
A study focusing on the tibial-peroneal atherectomy group, which included 423 patients, revealed significant findings. Of these, 202 patients received office-based treatments, with about 44.6% needing repeat interventions, and 221 were treated as hospital outpatients, with 34.8% undergoing repeat procedures.
Strikingly, the rate of any lower extremity amputation was 4.4% for office-based patients compared to 10.4% for hospital outpatients, with the rate of major lower extremity amputation being 3% and 7.2%, respectively. [3]
Patients with artery disease face a precarious situation where both intervention and non-intervention carry risks. Having already discussed the risks of outpatient atherectomy procedures, it's important to also consider the dangers of untreated artery disease.
Without proper management, artery disease can lead to chronic pain, mobility issues, gangrene, and ultimately, amputation. This dichotomy places patients in a challenging position, essentially caught between the risks of surgical intervention and the progressive nature of untreated vascular disease.
The choice between undergoing atherectomy and managing the disease conservatively underscores the need for a nuanced, patient-centered approach in vascular medicine. The decisions must weigh the immediate benefits of symptom relief and improved blood flow against the long-term risks of surgery or the natural progression of the disease.
In either scenario, patients are navigating a complex situation where the best choice often depends on individual health profiles, the severity of the disease, and the potential for both medical and surgical interventions to improve or worsen their quality of life.
An atherectomy procedure involves removing plaque from the arteries to improve blood flow. It's minimally invasive and can be performed using various devices, such as laser, rotational, or directional cutters, depending on the location and type of plaque.
Atherectomy device recalls are issued when the equipment is found to have defects or poses safety risks, necessitating an evaluation of the device's safety and effectiveness in medical procedures. Patients should consult their healthcare provider to understand if their treatment is affected and discuss alternative treatment options if necessary.
Patients can protect themselves from unnecessary procedures by seeking second opinions, researching their condition and treatment options, discussing the necessity and risks of the procedure with their healthcare provider, and ensuring their treatment plan is based on evidence-based guidelines.
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