Last Updated: July 2026

Status: Subject to change as litigation and legal standards evolve.

What Are Medical Devices?

A medical device is any equipment, instrument, or apparatus used in medical care or treatment. Medical devices range from simple items like bandages and crutches to complex implants and machines.

Medical devices are regulated differently from medications. The U.S. Food and Drug Administration (FDA) oversees medical devices to help protect public health and safety. This includes reviewing devices before they are sold, monitoring their safety after they are on the market, and ordering recalls when devices are found to be dangerous.

Categories of Medical Devices

Medical devices fall into different risk categories:

• Low-risk devices: Simple items like bandages, elastic supports, or tongue depressors
• Moderate-risk devices: Blood pressure cuffs, surgical gloves, wheelchairs
• High-risk devices: Surgical implants (like mesh or joint replacements), pacemakers, stents, and devices used during surgery

This guide focuses on complications involving higher-risk medical devices, particularly implants that remain in the body for years or decades.

What Is the FDA and Its Role?

The Food and Drug Administration (FDA) is a federal agency that regulates medical devices sold in the United States. The FDA’s role includes:

• Reviewing new medical devices before they are approved for sale
• Setting safety and effectiveness standards
• Monitoring devices after they reach the market
• Ordering recalls of dangerous devices
• Investigating complaints from doctors, hospitals, and patients

The FDA does not test every device itself. Instead, manufacturers conduct testing and submit data to the FDA showing the device is safe and effective. The FDA reviews this data and decides whether to allow the device to be sold.

Important Point

FDA approval or clearance does not guarantee that a device is completely safe or without risk. It means the device has met certain regulatory requirements, but complications can still develop, and new risks may be discovered after a device is already on the market.

What Is 510(k) Clearance?

510(k) clearance is one type of FDA approval pathway for medical devices. Many medical devices that are implanted in the body go through the 510(k) process.

What 510(k) Means

The term “510(k)” refers to a section of federal law. A 510(k) submission is a process where a manufacturer shows that a new medical device is substantially similar to devices already on the market.

In simple terms: The manufacturer compares the new device to an existing device that the FDA already approved. If the FDA agrees they are substantially similar, the new device is cleared for sale.

How 510(k) Works

1. The manufacturer identifies an already-approved device that is similar to their new device
2. The manufacturer submits data showing the new device is similar in design, materials, and intended use
3. The FDA reviews this comparison (usually within 90 days)
4. If the FDA agrees the devices are substantially similar, the new device receives 510(k) clearance
5. The device can then be sold to consumers

What 510(k) Does NOT Mean

• It does not mean the device is absolutely safe – It means it is similar to an already-approved device
• It does not mean the device was tested for long-term safety – It only requires similarity to an existing device
• It does not mean all risks are known – New complications can develop after a device is on the market
• It does not mean the device cannot cause harm – It means it was cleared based on similarity to an approved device

Criticism of 510(k)

Some attorneys and medical professionals argue that the 510(k) process may not adequately protect patients because:

• It does not require extensive testing by the FDA
• It relies on comparing new devices to older devices
• New problems with the older device may not be discovered until after the new device is also on the market
• Updates to device materials or design may not require new FDA review

FDA Recall Process

When the FDA determines that a medical device poses a health risk, it may order a recall. A recall means the device should be removed from the market or from patients’ bodies.

Types of FDA Recalls

The FDA divides recalls into three classes based on how serious the risk is:

Class I Recall: The most serious. The device poses a serious health risk or could cause death or permanent injury. The FDA strongly urges patients and healthcare providers to stop using the device immediately.

Class II Recall: The device may cause health problems but is less likely to cause serious harm. Healthcare providers are urged to stop use, but the risk is less urgent than Class I.

Class III Recall: The device may not be effective or may pose only a minor health risk. Use should be discontinued, but the urgency is lower.

How Recalls Happen

1. Discovery: The FDA, a manufacturer, or healthcare providers report safety problems
2. Investigation: The FDA investigates whether the device actually poses a risk
3. Decision: The FDA decides if a recall is necessary
4. Announcement: The FDA announces the recall publicly
5. Removal: Manufacturers and healthcare providers are directed to stop selling or using the device
6. Patient Notification: Patients who have the device are notified and may be told to contact their doctors

Patient Options After a Recall

If a patient has a recalled device implanted in their body, options may include:

• Monitoring by a doctor without removing the device (if the risk is not severe)
• Surgical removal of the device
• Replacement with a different device
• Medical management of complications that may arise

The decision depends on the type of device, the risk involved, and the patient’s health.

Recalls Do Not Determine Liability

An important legal principle: A device recall does not automatically mean a manufacturer is liable for injuries. However, a recall can be important evidence in a lawsuit. If a device is recalled because it causes injuries, that information can help support a claim that the device was defective.

Long-Term Health Risks of Implanted Devices

Implanted medical devices can remain in the body for years or decades. Long-term complications may develop over time, sometimes years after implantation.

Types of Long-Term Complications

Infection: Bacteria can form around or on an implant, causing chronic or recurring infections.

Migration or Shifting: An implant may shift from its original position, causing pain, discomfort, or loss of function.

Material Breakdown: Materials used in an implant may degrade over time, potentially releasing particles or causing inflammation.

Tissue Reaction: The body’s immune system may react to the implant, causing inflammation, scarring, or other tissue damage.

Device Failure: The device may stop working properly, requiring additional surgery to repair or replace it.

Allergic or Inflammatory Response: Some patients may develop an allergic or inflammatory response to the materials in the implant.

Erosion: The implant may gradually wear through surrounding tissue or organs.

Common Medical Device Complications: Real Examples

Breast Mesh and Surgical Implants

What it is: Surgical mesh products used in breast reconstruction, augmentation, or hernia repair procedures.

Allegations: Plaintiffs allege that certain mesh products may cause serious complications including infections, scarring, mesh migration (shifting from its intended location), pain, and the need for additional surgeries to remove or revise the mesh.

Long-term risks: Some mesh products may cause chronic pain, inflammation, or complications years after implantation.

Litigation status: Cases involving breast mesh products are being coordinated in federal courts. Lawsuits allege both manufacturing defects and failure to warn about complications.

Legal status: Some mesh products have been the subject of FDA recalls or Class II recalls warning of complication risks.

Endoscopy Equipment and Surgical Instruments

What it is: Medical equipment used during endoscopic procedures (minimally invasive surgeries where a camera is inserted to see inside the body).

Allegations: Plaintiffs allege that certain endoscopy equipment or instruments may cause serious injuries during procedures, including:

• Perforation or tearing of organs
• Infection from contaminated equipment
• Complications from equipment malfunction
• Unintended injuries during the procedure

Long-term risks: Infections or organ damage from endoscopy procedures may cause long-term complications, including sepsis, chronic pain, or need for additional surgery.

Litigation status: Cases involving endoscopy injuries are active in federal courts. Lawsuits allege manufacturing defects and inadequate warnings about risks.

Hip, Knee, and Other Joint Replacements

What it is: Surgical implants used to replace damaged hip, knee, shoulder, or other joints.

Allegations: Some patients allege that joint replacement devices may fail, wear out prematurely, or cause pain and complications requiring revision surgery.

Long-term risks: Over many years, joint implants may wear out, loosen, or cause allergic reactions to the materials used.

Litigation status: Some joint replacement devices have been recalled or have been the subject of lawsuits.

When Medical Device Injuries Occur

Medical device complications can happen in different ways:

During Implantation

An injury may occur during the surgery in which the device is implanted:

• The surgeon may inadvertently damage surrounding tissue
• The device may be placed incorrectly
• An infection may develop immediately after surgery

Shortly After Implantation

Complications may develop in the weeks or months after surgery:

• The body may react to the device
• An infection may develop
• The device may be placed incorrectly and cause pain
• The patient’s body may reject the device

Years After Implantation

Long-term complications may develop years after implantation:

• The device may wear out or fail
• Materials may break down
• Chronic infections may develop
• Scarring or tissue damage may occur
• The body may react to the device after years of contact

Medical Device Complications and Liability

When Manufacturers May Be Liable

A manufacturer may be liable for device-related injuries if the device had:

• A design defect (the device was designed unsafely)
• A manufacturing defect (something went wrong in production)
• Inadequate warnings about known risks or complications
• Failure to recall the device when safety problems were known

When Manufacturers May Not Be Liable

A manufacturer may not be liable if:

• The patient used the device in a way not intended by the manufacturer
• The surgeon made an error during implantation (surgeon error, not device error)
• The patient did not follow post-surgery instructions
• The injury was a known risk that was adequately warned about

The Role of FDA Approval

The fact that a device received FDA 510(k) clearance does not protect the manufacturer from liability if the device turns out to be defective or dangerous. Even FDA-cleared devices can be the subject of product liability lawsuits.

Key Medical Device Terms

Understanding medical device terminology helps you understand your situation:

• Implant: A medical device surgically placed inside the body, intended to stay there permanently or for a long time.
• Biocompatibility: How well a medical device material tolerates being in contact with the body without causing harm, rejection, or allergic reaction.
• Adverse Event: A medical problem or injury related to using a medical device.
• Complaint: A report of a problem with a device, submitted by a patient, doctor, hospital, or manufacturer to the FDA.
• Recall: An official action to remove a medical device from the market or from patients’ bodies due to safety concerns.
• Contraindication: A condition that makes it unsafe to use a particular medical device.
• Complications: Unexpected or harmful effects that develop as a result of using a medical device.
• Revision Surgery: A second surgery to repair, replace, or remove an implanted device.
• Bioburden: The amount of living microorganisms (bacteria) on a medical device or material.

Why Documentation and Medical Records Matter

If you believe you were injured by a medical device, documentation is critical:

Medical Records

• Records of the implant surgery, including what device was implanted
• The device serial number or lot number (can be found in medical records)
• Follow-up appointment notes documenting complications
• Imaging studies (X-rays, CT scans) showing the device location or problems
• Pathology reports if tissue was removed
• Records of any infections or treatments

Product Information

• The device name, model, and serial number
• The manufacturer’s name
• Packaging or inserts that came with the device
• Any warnings or instructions provided

Timeline

• When the device was implanted
• When complications first appeared
• Timeline of medical visits and treatments
• Any surgeries to remove or replace the device

Correspondence

• Messages to your doctor about complications
• Communications with the hospital or manufacturer
• Insurance documents related to treatment

Why This Matters

Strong documentation helps:

• Prove what device was implanted
• Show when complications developed
• Demonstrate that the device caused the complications
• Support claims for damages

Why Legal Review Matters

Whether you may have a medical device claim depends on your individual circumstances:

• What device was implanted?
• When was it implanted?
• What complications developed?
• When did complications appear?
• Do you have medical records documenting the device and complications?
• Has the device been recalled?
• Were you warned about the risk of complications?
• Where do you live, and what are your state’s time limits for filing?
• Did the surgeon make an error, or was it a device problem?

A legal review can help determine whether your situation may fit within a medical device injury category. A legal review does not guarantee a successful outcome, but it can clarify whether you may have a claim based on your facts.

Red Bird Legal’s Role in Medical Device Complications

Red Bird Legal works with law firms handling medical device injury cases across multiple device categories. The firm assists in case evaluation, intake, and coordinating claims involving device complications, implant injuries, and device-related health problems.

Red Bird Legal does not guarantee outcomes or settlements. Each case is unique, and results depend on individual facts, available evidence, applicable law, and jurisdiction.

Important Information About FDA Standards and Litigation Status

The status of related litigation may change as new evidence, court rulings, or regulatory developments emerge. What is described in this page reflects the general landscape as of the date listed above.

FDA standards and recall decisions may change. New scientific evidence or public health data may lead the FDA to issue recalls or change its guidance on device safety.

Medical understanding of device complications may evolve over time. New studies may reveal long-term risks that were not previously known or understood.

Device approval does not guarantee safety. FDA clearance or approval means a device met certain regulatory requirements at the time of approval, but complications can still develop, and new risks may be discovered.

Eligibility depends on individual facts, including:

• The specific device implanted
• When it was implanted
• The type and timing of complications
• Location (where you live and where the surgery was performed)
• Available medical records and documentation
• Applicable state laws and statutes of limitations

Disclaimer

This page is for informational purposes only and is not legal advice. Reading this page or submitting a form does not create an attorney-client relationship.

The status of related litigation, FDA standards, regulatory guidance, and medical understanding may change. Eligibility depends on individual facts, including the device implanted, timing of implantation, complications developed, location, records, and applicable law.

No outcome, settlement, compensation, or recovery can be guaranteed.

If you believe you may have been injured by a medical device, consider speaking with an attorney to discuss your individual situation.

Source Notes

Information in this page is based on:

• U.S. Food and Drug Administration (FDA) regulations and guidance on medical devices
• FDA information on 510(k) clearance process
• FDA information on medical device recalls and safety
• Federal court procedures for product liability and medical device litigation
• Medical literature and research on device complications
• Federal court dockets and case management orders for active medical device MDLs
• Approved legal intake criteria and case definitions used by attorneys handling medical device litigation

All claims and allegations referenced reflect how lawsuits characterize alleged harms. Allegations are not proven facts without evidence or admission.

Last Updated: June 2026

Next Review: December 2026

This information is subject to change and should be reviewed regularly as FDA standards, litigation developments, and medical understanding evolve.