The U.S. Food & Drug Administration (FDA) administers the regulation of pharmaceutical and other medical devices to protect and promote public safety. The FDA issues notices and alerts regarding any health risks connected to certain medical products. However, the full extent of the dangers attributable to medical products may be grossly understated. This may be especially true for the medical implant industry. This blog discusses recent independent investigations into the hidden dangers of medical implant devices.
FDA Reporting Issues
According to an article published by the International Consortium of Investigative Journalists (ICIJ), medical implant manufacturers have misrepresented the full extent of the attendant risks of their products to government regulators. Federal regulations require medical device companies to report adverse cases that arise from their products — however, pervasive misreporting and underreporting activities plague the medical implant industry.
According to the ICIJ investigation, obscurity regarding implant device injuries stems from 3 critical regulatory failures:
- FDA Reporting Violations. Inspections conducted by the FDA uncovered over 4,400 violations of federal rules for reporting and complaint handling in the medical device industry. Each violation can involve hundreds of improperly handled complaints.
- Misclassifications. Implant device manufacturers misclassified over 2,000 patient deaths as injuries or malfunctions.
- Undisclosed Reports. Thousands of injury reports have been shrouded under the FDA’s alternative summary reporting program which allows the industry to keep adverse reports out of public reach.
Internationally, transparency programs for medical device injuries are unheard-of. For example, Europe’s Eudamed adverse events database does not allow public access in the absence of a Freedom of Information request. Other countries have no corresponding system of documenting medical device injuries altogether.
An example of a potentially dangerous medical device is the Essure birth control system. The system utilizes metal coils which are implanted into a woman’s fallopian tubes. The device is designed to promote the development of scar tissue around the implants to block pregnancy permanently.
According to reports in the British Medical Journal, women with Essure implants are 10 times more likely to require additional surgical maintenance compared to women with tubal ligation (tube-tying) operations.
Suspected injuries connected to the Essure system surged from 25 instances to 12,564 in the past 7 seven years. This boom in adverse reports drove the FDA to issue a safety warning in 2016, and a sales restriction in 2018.
User-reported symptoms and complications associated with Essure implants include:
- Abdominal pain;
- Weight fluctuations;
- Excessive fatigue;
- Persistent fever;
- Autoimmune disorders;
- Extreme pelvic pain;
- Perforation surrounding organs; and
- Implant migration into the lower abdomen or pelvis.
Another example of a hazardous medical device is transvaginal mesh. Transvaginal mesh is used to strengthen the walls of the vagina by implanting the device in the vaginal canal. The mesh is made from a thin sheet of spongey polymer or biopolymer-based material. The device is used to treat pelvic organ prolapse and unrainy incontinence. However, thousands of women have reported severe injuries or complications after implantation. Subsequent disorders also necessitated follow-up corrective surgeries.
Common transvaginal mesh complications and symptoms include:
- Scar tissue from mesh erosion;
- Scarring caused by mesh contraction;
- Persistent bleeding and pain;
- Urinary incontinence; and
- Perforation of the urinary tract and bladder.
Consult a Qualified Cleveland Unsafe Products Attorney
If you are suffering from complications or injuries as a result of a medical device or pharmaceutical product, you should call an unsafe products attorney in Cleveland. At Spangenberg Shibley & Liber LLP, we have over 20 years of experience representing Cleveland residents in cases involving injuries caused by dangerous medical devices. We are dedicated to providing you with quality legal representation that focuses on your individual needs. You can count on us to zealously advocate for your right to obtain recompense for injuries you sustained due to a defective medical product.
Call Spangenberg Shibley & Liber LLP today or contact us online to schedule an appointment to discuss your legal options.