Since 1976, the Food and Drug Administration (FDA) has regulated the quality and safety of implantable medical devices. The FDA mandates that manufacturers must demonstrate the safety and effectiveness of their devices before marketing them. This way, they can identify clinical and ethical problems and offer a solution.
Sometimes, however, implantable medical devices for women receive minimal review and scrutiny. That’s because of the lack of available trial testing opportunities to explore every avenue. Due to this, women suffer severe consequences. For example, the structural failure of implanted contraceptive devices once led to organ damage, internal bleeding, etc.
Some researchers believe that gender bias can inadvertently affect the testing, clinical trials, and regulatory approval processes. Therefore, bad outcomes from copper intrauterine devices (IUDs), vaginal mesh, and breast implants are considered to be cumulative consequences of inattention and bias.
In this blog, we will discuss what happened with such implantable medical devices that compelled women to take the legal route.
#1. Copper Intrauterine Devices (IUDs)
The use of hormonal IUDs led women to develop side effects like irregular bleeding, pelvic pain, cramping, dizziness, ovarian cysts, etc. That’s why the medical industry introduced a non-hormonal IUD made from copper ions called the Paragard IUD. Manufactured by Teva Pharmaceuticals, these T-shaped devices were highly effective in stopping sperm from reaching the egg by inflaming the uterus.
However, Paragard IUDs soon became a nightmare to remove. That’s because it fractured and migrated inside the woman’s uterus when doctors tried to pull it out. As a result, these women suffered from internal bleeding, organ damage, infection, infertility, etc. Due to these health issues, most of the victims needed to undergo expensive surgeries to preserve their quality of life.
That’s why almost 2,300 women filed a Paragard lawsuit against the manufacturers. This ongoing lawsuit alleges that the company failed to warn the victims about the potential risks. Hence, women seek compensation for damages like lost quality of life, wages, suffering, permanent disability, medical bills, etc.
According to TorHoerman Law, plaintiffs must present proof like medical records, device information, doctor’s notes, and surgical treatments. These will act as evidence for the Paragard IUD lawsuit to help plaintiffs get the rightful compensation. Technically, the victims can receive financial payouts worth USD 10,000 to USD 400,000.
#2. Vaginal Mesh
Approximately 50% of older women suffer from involuntary urinary incontinence. One type would be stress urinary incontinence, which happens due to physical activities like coughing, sneezing, jumping, etc. To treat this, the medical industry created an invasive transvaginal or vaginal mesh implant when non-surgical options were unsuccessful.
Initially, it became a successful way to treat stress urinary incontinence. However, the manufacturers were negligent in their testing methods and didn’t use high-quality designs due to budget restrictions. Even then, they marketed this device as a safe way to handle stress incontinence, and women believed them.
Unfortunately, the mesh eroded inside the woman’s body, leading to severe pain, bleeding, organ perforation, infection, etc. Eventually, the victims filed a vaginal mesh lawsuit against the manufacturers.
These lawsuits alleged failure to warn and medical negligence, making healthcare providers and patients unaware of the potential complications. Hence, the plaintiffs wanted compensation for lost wages, physical suffering, medical expenses, and emotional damages.
While 95% of the transvaginal mesh lawsuits have already been settled, lawyers are still taking on new cases. Based on the proof, women can receive settlement amounts between USD 150,000 and USD 400,000.
#3. Breast Implants
The breast augmentation market in America is set to reach USD 7.8 billion by 2032. Moreover, in 2022, breast implants held a revenue share of a whopping 30%. These statistics prove how common and popular breast implants are among women in America. According to the Mayo Clinic, women augment their breasts to enhance their appearance, improve self-confidence, and correct uneven breasts.
That’s why an American medical device giant, Allergan, introduced the Natrelle BIOCELL textured implants. Plastic surgeons used this product in breast reconstruction procedures to replace tissue in women who suffered trauma or had cancer. However, FDA research soon proved that these implants carry a higher risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
That’s why affected individuals filed a lawsuit against Allergan for this breast implant. The lawsuits allege that the company failed to warn women of the potential side effects and risks of getting this implant. In 2019, the FDA forced this company to recall almost 246,381 breast implant devices. As of November 2023, 1,198 Allergan lawsuits were pending.
In conclusion, women need to be careful about the implantable medical devices they put in their bodies. If these devices fail, it can lead to adverse health consequences. For example, non-hormonal copper IUDs were deployed on the frontlines of patient care as a safe contraceptive option. However, its failure led to a whirlwind of consequences like organ damage and fertility issues, leading to controversy and legal action.