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Report Links Defective Medical Implant Devices to Lax Government Regulations

A 2018 report from the International Consortium of Investigative Journalists (ICIJ) paints a troubling picture for people who rely on medical implants to resolve their chronic pain or other health issues safely. The report claims that due to poor regulation by health authorities and oversight organizations such as the U.S. Food and Drug Administration (FDA), many of these medical devices have been found to be defective, causing harm to unsuspecting patients in the United States and around the world.

According to the ICIJ, in the past decade the FDA has been notified of more than 5.4 million instances in which medical devices malfunctioned in a potentially harmful way or are suspected to have contributed to a serious injury or death. In response to these “adverse event” reports to the FDA, 2,100 Class I product recalls were issued — including recalls of devices already implanted in millions of people. The FDA defines a Class 1 recall as one in which defective products “predictably could cause serious health problems or death.”

The ICIJ report noted that poor regulation was not the only factor leading to defective medical devices. Medical technology companies regularly give perks, including substantial amounts of money, to surgeons and doctors to participate in company-sponsored events. The implication is that, in return, those doctors and surgeons will push the company’s products. The ICIJ stated that in 2017, doctors and hospitals in the United States received close to $600 million from the 10 largest manufacturers in the medical device injury.

Among the major medical technology manufacturers that have been subject to legal scrutiny in recent years is Boston Scientific, one of the largest companies in Massachusetts. In May 2018, CBS News reported that 48,000 defective product lawsuits were brought against Boston Scientific for the company’s vaginal mesh product, with plaintiffs claiming that the device could “inflict life-altering pain and injury.” Boston Scientific is also a major manufacturer of spinal cord stimulators — devices that have helped some patients but left others in significant pain.

Before you agree to have a medical device implanted, ask your doctor to thoroughly explain all of the risks involved, and do your own research about the pros and cons of each option you are given. If a defective medical device ends up hurting you more than it helps, the manufacturer may be liable for your injury and suffering.

The attorneys at Swartz & Lynch LLP are experienced at handling medical products liability lawsuits. From our office in Boston, we represent clients throughout the city and in the surrounding neighborhoods of Suffolk County who have been harmed by defective medical devices. Call us at 857-250-0664 or contact us online to arrange your free initial consultation.

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