In 2015, an estimated 15.9 million surgical and minimally-invasive cosmetic procedures were performed in the United States. Plastic surgery such as liposuction, rhinoplasties, and breast augmentations have given people around the world the opportunity to change things they dislike about their bodies and has become increasingly popular. In fact, approximately 280,000 breast implant procedures were performed in 2015. Many women who decide to get breast implants experience few or no complications, however, that is not the case for everyone. In fact, it appears some women report their silicone breast implants have caused serious adverse side effects. While breast augmentations are generally successful, complications and illness have been reported with one type of implant in particular: MemoryGel Silicone Breast Implants.
Our firm is currently investigating MemoryGel Silicone breast implant cases. The following symptoms or illness may occur in patients with failed implants:
- Extreme and chronic fatigue
- Muscle pain
- Muscle weakness
- Muscle cramps
- Bone pain
- Swelling in the joints
- Pain in the joints
- Memory loss
- Shortness of breath
- Nausea and dizziness
- Numbness in the extremities
- Issues with vision
- Weight gain
- Heart palpitations
What Is The Problem With MemoryGel Silicone Breast Implants?
On February 2, 2017, Rexina Mize and her husband Minh Nguyen filed a lawsuit against Mentor Worldwide LLC; Johnson & Johnson; Ethicon, Inc. in the Superior Court of California County of Los Angeles for the following:
- Failure to warn consumers about the dangers of the product
- Manufacturing defect
- Breach of implied warranty, and
- Loss of consortium, or damages suffered
The plaintiffs in the case allege that Mentor failed to warn consumers of known risks associated with the devices. Additionally, the plaintiffs allege the manufacturer failed to both follow an important six-part post-approval process required by the FDA. At least one other similar lawsuit has been filed against Mentor.
A Brief History of MemoryGel Silicone Breast Implants
Mentor Worldwide LLC has been in the business of manufacturing medical devices since 1969. After more than a decade of selling electronic lab instruments, the company began developing breast implant devices, which have now been used for more than five million surgeries. In December of 2003, Mentor Worldwide LLC submitted a pre-market approval application for a new product, MemoryGel Silicone implants. In November 2006, the FDA granted permission for the implants to be used in breast augmentation and reconstruction surgeries as long as certain requirements were followed. The approval was contingent upon six-part post-approval studies that were required to be conducted once the product was launched. These studies were intended to characterize the safety and effectiveness of MemoryGel devices and to answer scientific questions the pre-market clinical tests did not. The required studies included assessing the long-term performance of the devices, documenting rare adverse events and device failures, and improving patient labeling.
The plaintiffs in the suit argue that in order to fulfill this responsibility, Mentor should have closely monitored the information that became available through the post-market studies and provided updated safety not only to the FDA, but also to the healthcare community and consumers. Failing to do so could have prevented researchers and those in the medical community from quickly identifying any potential health and safety issues associated with using the device. The plaintiffs believe the manufacturer failed to fulfill these responsibilities and warn consumers about the serious health risks with the MemoryGel Silicone implants.
How Can You Tell If Your Breast Implants Are Leaking?
Plastic surgeons familiar with breast implants may only detect about 30% of ruptures occurring in breast implants, while an MRI can detect around 80% or more of ruptures or leaks in implants. Symptoms of a leaking implant may include:
- Hard knots or lumps around the implant, surgical site, or armpit
- Deformity of the breast
- Change in shape or loss of size
- Pain or burning
- Tingling or swelling
- Hardening of the breast
How Can You Tell If Your Breast Implants Have Failed?
Patients with defective MemoryGel Silicone breast implants may experience chronic fatigue, muscle pain or weakness, memory loss or confusion, show symptoms of silicone toxicity and/or other implant-related illness. Your plastic surgeon may want to remove or replace the implants if this occurs. If you’ve experienced health complications or needed to have your breast implants changed or removed, call the product liability attorneys at The Ruth Law Team at 1-888-783-8378, or fill out our free case evaluation form to the right of the page. As always, we offer 100% free case evaluations, and there are no costs or fees to you unless you win.