Your Rights as a Patient When a Medical Device Fails

When you agree to a medical procedure, you trust that the devices used in your body have been properly tested and that your doctor has accurate information about the risks. When a medical device like breast mesh fails, that trust is broken. But you are not powerless. Federal and state laws give patients specific rights — and understanding those rights is the first step toward protecting yourself.

The Right to Informed Consent

Before any surgery, your doctor is legally required to obtain your informed consent. This means more than just signing a form. Informed consent requires that your doctor explain the procedure, the risks and benefits, alternatives to the procedure, and the risks of doing nothing. You must have enough information to make a genuinely informed decision about your own body.

For breast mesh patients, informed consent raises important questions. Did your surgeon explain that mesh would be used? Did they describe the specific product and its track record? Were you told about the known risks of mesh complications, including capsular contracture, chronic pain, infection, and the potential need for revision surgery? Were you informed about alternatives to mesh-based reconstruction?

If you were not adequately informed about the mesh product used in your surgery — including its risks and alternatives — your right to informed consent may have been violated. This can be the basis for a legal claim against your surgeon, the hospital, or both. Separately, if the mesh manufacturer failed to provide your surgeon with accurate risk information, your surgeon may not have been able to give you proper informed consent even if they tried. In that scenario, the manufacturer may bear liability.

The Right to Safe Medical Devices

Federal law, primarily through the Federal Food, Drug, and Cosmetic Act, requires that medical devices sold in the United States meet safety standards. Manufacturers must demonstrate that their products are safe and effective before they can be sold. They are also required to monitor their products after they reach the market and report adverse events to the FDA.

In practice, the level of safety testing depends on how the device reaches the market. Devices cleared through the FDA's 510(k) process — which includes many surgical mesh products — face less rigorous testing requirements than devices that go through the premarket approval (PMA) process. The 510(k) pathway requires manufacturers to show that their device is "substantially equivalent" to an existing product, not that it is independently safe and effective.

Despite these regulatory differences, all manufacturers have a duty to produce devices that are reasonably safe when used as intended. When a device causes harm due to defective design, manufacturing errors, or inadequate warnings, patients have the right to hold the manufacturer accountable through product liability claims.

The Right to Accurate Information About Your Implant

You have the right to know exactly what was implanted in your body. This includes the product name, manufacturer, model or catalog number, and lot number. This information should be recorded in your operative report and may also appear in your hospital discharge records and implant registry cards.

If you do not know what breast mesh product was used in your surgery, you can obtain this information by:

• Requesting your operative report from the hospital or surgical center
• Asking your surgeon's office for implant records
• Checking whether you received an implant card or device identification card after surgery
• Contacting your health insurer for procedure codes and device information from billing records

The FDA has been working to improve device tracking through the Unique Device Identification (UDI) system, which assigns a unique code to each medical device. If your mesh has a UDI, it can be used to look up the product in the FDA's Global Unique Device Identification Database (GUDID) to find details about the manufacturer, device type, and any safety notices.

The Right to Report Problems

Patients have the right — and are encouraged — to report medical device problems directly to the FDA. The MedWatch reporting system allows anyone to submit a voluntary adverse event report. You do not need to go through your doctor, although your doctor can (and should) also file a report.

Adverse event reports serve multiple purposes. They contribute to the FDA's safety surveillance for a product. When enough reports accumulate, they can trigger safety investigations, warning letters to manufacturers, label changes, or product recalls. They also become part of the public record that attorneys use when building cases against manufacturers.

To file a report, visit the FDA MedWatch website and complete the voluntary reporting form. Include as much detail as possible: the product name, manufacturer, lot number (if known), a description of your complication, and the dates of your surgery and symptom onset. You can file a report at any time — there is no deadline.

The Right to Seek Legal Compensation

When a medical device causes harm, patients have the right to pursue legal compensation from the responsible parties. This typically means filing a product liability lawsuit against the device manufacturer. Depending on the circumstances, claims may also be filed against the surgeon, the hospital, or the distributor.

Compensation in medical device cases may cover:

• Medical expenses: Past and future costs of treating mesh-related complications, including revision surgery, medications, physical therapy, and specialist visits.
• Lost income: Wages lost due to recovery from complications, inability to work, or reduced earning capacity.
• Pain and suffering: Physical pain, emotional distress, anxiety, depression, and loss of enjoyment of life caused by the device failure.
• Loss of consortium: Impact on your relationship with your spouse or partner due to your injuries.
• Punitive damages: In cases where the manufacturer's conduct was particularly reckless or egregious, courts may award additional damages meant to punish the company and deter similar behavior.

Most medical device lawsuits are handled on a contingency basis. You pay no upfront legal fees. The attorney's fee comes from any settlement or verdict. If there is no recovery, you owe nothing.

The Right to Access Your Medical Records

Under the Health Insurance Portability and Accountability Act (HIPAA), you have the right to access and obtain copies of your medical records. Healthcare providers must respond to your request within 30 days (with a possible 30-day extension). They can charge a reasonable fee for copies, but they cannot refuse to provide them.

Having copies of your own records is especially important if you are considering a legal claim. Records can be lost when practices close, doctors retire, or record systems change. Having your own copies ensures that the documentation supporting your case is preserved regardless of what happens to the healthcare providers who treated you.

If a provider is unresponsive to your records request, you can file a complaint with the Department of Health and Human Services Office for Civil Rights, which enforces HIPAA. Your attorney can also assist with records requests and may have more efficient methods for obtaining medical documentation.

The Right to a Second Opinion

If you suspect your breast mesh is causing problems, you have every right to seek a second opinion from another surgeon or specialist. In fact, seeking a second opinion is often recommended, especially when the proposed treatment involves additional surgery like mesh removal.

A second opinion can confirm or challenge the original diagnosis, suggest alternative treatments, and provide additional documentation for your medical record. Some surgeons specialize in mesh removal and complications — they may have experience and perspective that your original surgeon does not.

Insurance plans generally cover second opinions, and many plans require them for certain procedures. Even if your plan does not cover a second opinion, the out-of-pocket cost is often worth the peace of mind and the additional medical perspective.

Protecting Your Rights: Steps to Take Now

If you believe a breast mesh product has harmed you, here are concrete steps to protect your rights:

1. Get your records. Request your operative report, medical records, and implant information from every provider involved in your care.
2. Report to the FDA. File a MedWatch adverse event report so your experience is part of the official safety record.
3. See a specialist. Consult with a surgeon experienced in mesh complications for an independent evaluation.
4. Document everything. Keep a written record of your symptoms, treatments, and how complications affect your daily life.
5. Talk to an attorney. A free case evaluation helps you understand whether you have a viable legal claim and what the next steps would be.

You did not choose to be harmed by a medical device. But you can choose how to respond. Knowing your rights is the foundation for every step that follows — from getting proper medical care to holding manufacturers accountable for the products they put in your body.