Consumers Union Advocates Stronger FDA Regulations for Vaginal Mesh & Metal Hips

Metal on metal hip complications and injuries from vaginal mesh devices have plagued thousands of patients. Many of the metal hip implants and vaginal mesh products that received FDA clearance are currently the subject of personal injury lawsuits, recalls, and safety reviews. In an attempt to protect patients from being exposed to defective medical devices in the future, the FDA proposed implementing a premarket clearance process that would require manufacturers to demonstrate the safety and effectiveness of high risk Class III products before they are distributed. The Consumers Union and other patient advocates have expressed their support for the proposed clearance process.

FDA clearance process for medical devices

On April 18, 2013, the Consumers Union submitted a letter to the FDA that encouraged the agency to adopt the premarket clearance process. The consumer advocacy group also supports the provision that requires manufacturers with metal hip implants already in the market to provide information to the FDA within a 90 day period confirming their devices are safe for patients to use. In the letter, the Consumers Union suggested that each manufacturer should be held to a due diligence standard that involves them directly contacting patients to explain the medical risks associated with the metal hip implants and recommend they get tested for metal poisoning on a yearly basis.

For years, patient advocates have asserted that section 510(k) of the Food, Drug and Cosmetic Act put the safety of patients in jeopardy by allowing the FDA to grant clearance for devices that were substantially equivalent to another device already in the market. Under the controversial “fast-track” clearance process, the manufacturers didn’t have to conduct clinical safety tests or submit their findings to the FDA as a prerequisite for receiving clearance to distribute and sell their products. As a result, patients were getting vaginal mesh devices, metal hip implants, and other medical products without being fully informed of the safety risks.

Metal on metal hip complications

The Consumers Union stated that all metal hip implants should be removed from the market due to the high failure rates and serious medical risks they’ve posed to patients. In 2011, Johnson & Johnson conducted an internal review that revealed an estimated 40% early failure rate for one of the metal hip implants manufactured by subsidiary company DePuy, according to a report published in the New York Times. Johnson & Johnson chose not to publicly disclose their findings and continued to distribute the metal hip implants. DePuy acknowledged that 12% – 13% of their ASR hip implants were failing within five years after the patients received them. A DePuy ASR metal on metal hip recall was finally issued five years after the device was introduced into the market.

Medical risks associated with the metal hip implants included metal poisoning, infections, chronic joint pain, necrosis, bone loss, nerve damage, and organ damage. Due to the severity of the injuries, many patients who experience these side effects need costly revision surgery to replace the defective metal hip implants.

Vaginal mesh complications

The Consumer Union also wants the provisions of the premarket clearance process to apply to vaginal mesh devices. In some cases, manufacturers were able to promote the vaginal mesh devices as a treatment for pelvic organ prolapse and stress urinary incontinence without performing thorough research or clinical studies to demonstrate that the products were safe.

The FDA received more than 1,000 adverse events reports from 2008 through 2010 regarding serious injuries linked to the vaginal mesh devices. Recurrence of urinary incontinence, vaginal scarring, mesh erosion, infections, and pain during sexual intercourse are some of the vaginal mesh complications experienced by women. During revision surgery, it is extremely difficult for physicians to completely remove the vaginal mesh once it has eroded into the soft tissues and organs. Getting a vaginal mesh implant has led to extensive vaginal scarring, infertility, and other permanent injuries for some women.

Consumer Union urges the FDA to make all Class III medical device implants subject to the rules and policies proposed in the premarket clearance process. Under the existing regulations, patients have been exposed to dangerous products that compromised their health. When patients suffer serious injuries, they are often unable to work, lose income, and are put into a position of severe emotional and financial distress. If the FDA eradicates the loopholes in their laws by requiring manufacturers to produce clinical information regarding the efficacy and safety of their medical devices, it may become an effective tool in protecting the welfare of numerous patients.