Defective Medical Devices Lawyer

Medical devices such as hip replacements, knee replacements, hernia mesh, transvaginal mesh, IUDs, pacemakers, and prosthetics have done wonders for the human body. But, when a dangerous or defective medical device causes you harm, you may have a viable product liability claim on your hands.

Although medical devices undergo rigorous testing before being used in corrective surgeries, unanticipated problems can arise. If you suffered complications after a surgical implant, a defective medical device lawyer can review your case and discuss your eligibility for compensation. Reach out to the seasoned legal team at Fleschner, Stark, Tanoos & Newlin today to get started.

FDA Regulation

Medical device manufacturers gain product approval by filing a 510(k) or a premarket approval application (PMA). A 510(k) alerts the FDA’s Center for Devices and Radiological Health (CDRH) that a device is equivalent to one already being marketed in the U.S. and that the applicant is seeking clearance to market a similar product. The FDA will approve a PMA if the applicant proves the new device is safe and effective.

If medical devices later cause complications for patients, the FDA can pull them from the market. Products can be dangerous or defective in their design, manufacturing, warning labels, and advertising, but most medical devices are found to be defective at the manufacturing level. For example, Bayer, a pharmaceutical giant that manufactures Essure permanent birth control devices, stopped selling Essure implants in the U.S. in December 2018.  In September 2019, the FDA called for healthcare providers to cease using these products due to defects.

Essure was found to migrate to other body parts, causing perforation of the uterus and fallopian tubes. Unfortunately, many women required corrective hysterectomies due to this damage. The FDA continues to monitor women who have been implanted with Essure before the recall.

Other medical devices that have been linked to patient injuries include:

• Hernia mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, Atrium Medical, Covidien, and C.R. Bard, used to repair hernias
• IVC filters used to reduce the risk of blood clots
• Birth control devices such as Mirena IUDs and NuvaRing
• Pelvic or transvaginal mesh used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI)

Patients implanted with dangerous products should contact our defective medical devices attorneys to learn more about seeking compensation for injuries.

Corrective Surgery and a Defective Product Claim

In a defective product lawsuit, the manufacturer is asked to compensate patients who are injured by their products. In turn, the manufacturers will demand that these patients provide proof that it was, in fact, their product that caused the injuries.

Preserving evidence is essential. For defective devices that are outside of the body, such as prosthetic limbs, patients should set the device aside, so it can be closely examined. If the device was implanted, patients must request that, before corrective surgery, their surgeons save the defective device after it is removed and replaced. Additionally, many surgeons take detailed notes for medical files, and some even photograph the procedure.

A Defective Medical Devices Attorney Seeks Compensation for You

While the way a lawsuit is handled depends on whether medical negligence or a defective product caused you harm, ultimately, the outcome remains the same. At Fleschner, Stark, Tanoos & Newlin, our attorneys will fight to see you compensated for your medical bills, pain, emotional trauma, and lost wages.

Call us to schedule your confidential consultation.