Thousands of women who are suffering from chronic pain and agonizing symptoms as a result of Essure contraceptive coils are struggling for justice because they are unable to claim compensation for their losses due to a 10-year liability limit on medical devices.
According to The Daily Mail, women in the United Kingdom only have ten years from the date of manufacture to make legal claims against pharma companies if something goes wrong with an implant coil or other device. Essure has affected women across the world, including thousands here in the United States.
Serious Safety Issues with Essure
Essure was a permanent form of birth control that was marketed as a non-surgical, minimally invasive option for women seeking sterilization. It consists of small, flexible coils made of nickel-titanium alloy inserted into a woman’s fallopian tubes. Once in place, these coils were intended to induce inflammation, causing scar tissue to develop and block the tubes, preventing sperm from reaching the eggs.
The procedure was promoted as a quick and relatively simple alternative to tubal ligation without the need for surgical incisions or general anesthesia. However, reports of serious side effects and complications associated with Essure led to significant controversy and subsequent withdrawal of the product from the market in various countries.
Many women reported adverse effects such as chronic pelvic pain, migration of the device, perforation of the fallopian tubes or uterus, allergic reactions to the nickel in the coils, and irregular bleeding. Some experienced unintended pregnancies and miscarriages even after undergoing the Essure procedure.
The mounting complaints and safety concerns prompted regulatory actions and investigations. In 2018, Bayer, the manufacturer of Essure, decided to halt sales of the device in the United States and subsequently discontinued its distribution worldwide by the end of 2019.
The controversy surrounding Essure highlighted the importance of thorough testing, transparent reporting of side effects, and patient awareness regarding the potential risks associated with medical devices. It also spurred discussions about the regulation and monitoring of such devices to ensure patient safety.
Side Effects of Vaginal Mesh Devices
The side effects from Essure are reminiscent of vaginal mesh products, which have also been recalled for causing problems. Vaginal mesh devices, also known as pelvic mesh or transvaginal mesh, were surgically implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) in women.
However, these devices became associated with severe and sometimes irreversible side effects, leading to numerous lawsuits and regulatory actions in the United States.
Some of the reported side effects and complications associated with vaginal mesh devices included chronic pain, mesh erosion, infection, urinary problems, bleeding, pain during intercourse, organ perforation, and recurrence of prolapse or incontinence.
These adverse effects often lead to debilitating physical and emotional consequences for affected individuals.
The use of vaginal mesh devices became highly controversial as reports of complications increased. Thousands of women filed lawsuits against manufacturers, alleging that the mesh products were defectively designed, lacked proper warnings about risks, and were inadequately tested before being marketed.
The sheer number of reported injuries prompted the Food and Drug Administration (FDA) to issue warnings about the risks associated with transvaginal mesh, reclassify these devices, and impose stricter regulations on their marketing and distribution.
Subsequently, several manufacturers faced litigation, paying significant settlements and judgments to affected individuals. Some manufacturers decided to discontinue or phase out their mesh products due to the substantial legal and financial repercussions.
The controversy surrounding vaginal mesh devices underscored the importance of thorough testing, adequate warnings, and a comprehensive understanding of the risks associated with medical devices to safeguard patient safety and prevent harm.
Who is Liable for Defective Medical Devices?
Liability in cases involving defective medical devices typically involves multiple parties that can be held accountable for the harm caused. The primary entities that may be held liable include:
Manufacturers: The manufacturer of the defective medical device can be held liable under product liability laws. This includes issues related to design defects, manufacturing defects, or inadequate warnings or instructions accompanying the device. Manufacturers have a duty to ensure that their products are reasonably safe for their intended use.
Distributors and retailers: Entities involved in the distribution chain, such as wholesalers, distributors, and retailers, may also bear liability if they were aware of the defects or failed to take appropriate action, such as issuing recalls or warnings.
Healthcare providers: In some cases, healthcare providers who were negligent in the selection, implantation, or monitoring of the device may face liability. This could include improper training, failure to inform patients of potential risks, or using the device inappropriately.
Regulatory bodies: Regulatory agencies that approved or oversaw the device’s clearance or failed to monitor its safety adequately may face scrutiny for their role in allowing a defective product onto the market.
When you have suffered injuries or side effects as a result of using Essure or vaginal mesh products, you must seek the guidance of an experienced product defect attorney who has successfully handled cases involving defective medical devices.
You may be able to seek compensation for damages, including medical expenses, lost income, hospitalization, the cost of surgery, permanent injuries, disabilities, pain and suffering, and emotional distress.
Source: https://www.dailymail.co.uk/news/article-12809401/Women-liability-limit-medical-products-horror-symptoms-claim-compensation.html
