Patients Allege Long-Term, Significant Injury Tied to Medical Devices
Thousands of individuals worldwide have suffered terrible, sometimes life-long and life-changing pain, due to implantation with allegedly defective medical devices such as transvaginal mesh, breast implants, and metal-on-metal hip implant devices, according to TheConversation.com.
Drugs testing and approval occurs through the use of clinical trials and placebos; however, many, if not most, medical device implants make it to the market without undergoing clinical trials. This occurs through the U.S. Food and Drug Administration’s (FDA) 510(k) clearance protocol. Due to this loophole, medical device manufacturers are able to market their devices with virtually no clinical trials or federal regulator review for safety and efficacy if the medical device maker is able to show that the new device is substantially similar to a previously approved device. In fact, under the 510(k) protocol, medical device makers must only file paperwork and pay a fee to federal regulators. Meanwhile, TheConversation.com notes that many implant makers are more concerned with and “highlight the regulatory ‘burden’ required to bring a new implant to market.”
The 510(k) process is in contrast to the agency’s pre-market approval (PMA) process, a route that mandates clinical data.
Following increasing controversy, in August 2015, the FDA sought to change the rapid clearance process for at least one device and mandated that device makers follow a stricter process when seeking approval to release metal-on-metal hips, The Converation.com pointed out.
The medical device lawyers at Parker Waichman LLP are well versed in medical device litigation. The firm has decades of experience in medical device litigation and continues to offer free legal consultations to individuals who have questions concerning filing a transvaginal mesh lawsuit.
Metal-on-metal hip devices, breast implants, and transvaginal mesh implants have allegedly left many patients seriously injured and others concerned about long-term effects of potentially defective implants in their bodies, reported TheConversation.com.
According to TheConversation.com. there are some factors that may lead to these issues. Despite some companies’ claims of a ensuring primary responsibility to their patients, most companies focus on profits, bringing implants to market rapidly and selling as many devices as possible, especially when clinical trials may be bypassed. In some cases, organizations may be focused on creating innovative medical implants that provide jobs and pay taxes, but are not focused on the patient. TheConversation.com points out that focusing on innovation may be a focus away from safety, efficacy, and cost. When seeking an innovative product, that product may lead to the obtaining of a patent, which may be used to generate income. It is possible that a safer implant does not carry the same potential for financial reward as an innovative implant.
Examples of Failing Medical Device Implants
Metal-on-Metal Hip Implant Devices
When metal-on-metal hip devices are implanted, the metal ball and the metal cup slide against each other during walking or running. Metal may be released from the implant where two implant components connect.
In 2011, the U.S. Food and Drug Administration (FDA) began a safety review of metal-on-metal hip replacement devices. In 2013, the agency confirmed that exposure to metal ions released from these devices may cause severe local tissue reaction, potentially entering the bloodstream and leading to additional symptoms or illnesses. The FDA also warned that metal-on-metal hips were associated with higher failure rates when compared to hip implants with different components.
Many metal-on-metal hip devices were brought to market via the 510(k). Lawsuits continue on various metal-on-metal hip devices.
Transvaginal Mesh Devices
Transvaginal mesh is used to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Both conditions are typically seen in women who are middle-aged and who have given birth. Pregnancy impacts muscles and other abdominal tissues that are meant to hold the body’s organs in place. These muscles and tissues weaken as women age, typically due to prior stress tied with pregnancy and carrying babies full-term. Weakening may cause the female body’s internal organs to begin to sag, pressing against the uterus. SUI is the involuntary release of urine during normal, everyday activities.
Traditional treatments involve creating a sling using a woman’s own tissue during invasive surgery; however, the use of surgical transvaginal mesh laparoscopically has more recently been used. Transvaginal mesh has led to complications. In fact, thousands of lawsuits have been filed against various mesh makers and pelvic mesh injury reports have added to safety concerns. Women similarly allege that transvaginal mesh implants caused them serious, often permanent injuries. Numerous lawsuits point out that transvaginal mesh implants were not clinically tested for safety or efficacy before they were sold and implanted in thousands of women as the devices were approved through the 510(k) clearance route. Transvaginal mesh has since been reclassified from “moderate-risk” to “high-risk,” meaning the products may no longer be approved through the 510(k) and must be cleared through the stricter PMA route.
Women allege transvaginal mesh caused injuries, including mesh erosion through the vagina (exposure, extrusion, or protrusion); pain; infection; bleeding; pain during sexual intercourse; organ perforation; prolapse recurrence; incontinence and urinary problems,; and bowel, bladder, and blood vessel perforation. The FDA initially indicated that transvaginal mesh complications were serious, but rare. The agency updated this communication in 2011, clarifying that transvaginal mesh complications are, in fact, “not rare” and pointed out that there is inadequate evidence to support the use of transvaginal mesh over non-mesh methods.
As far back as 2011, the FDA began to discover a potential tie between breast implants and the development of a rare type of non-Hodgkin’s lymphoma known as anaplastic large cell lymphoma (ALCL). A report summarizing the agency’s findings focused on the need to collect additional information on how to better characterize ALCL in women with breast implants. The FDA indicated that it has bolstered its understanding of ALCL since 2011 and agrees with the World Health Organization’s (WHO) designation of breast implant-associated (BIA) anaplastic large cell lymphoma, also known as BIA-ALCL, as a rare T-cell lymphoma that may develop following breast implants.
Of 359 reported cases of the cancer, 231 included information about the implant surface: 203 were textured implants, and 28 were smooth. According to the Times, the contents of the implants appeared much less important than the implant’s texture. Of the 312 cases in which the implant’s contents were known, 186 were filled with silicone gel and 126 with saline. To date, nine deaths are associated with the cancer.
Filing a Medical Device Lawsuit
If you or someone you know suffered injuries related to the use of a medical device, you may have valuable legal rights. Our medical device lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).