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.
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Frequently Asked Questions About MemoryGel Silicone Breast Implants
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At The Ruth Law Team, we understand that this may be your first time seeking legal counsel and how intimidating that decision might be. This is why we have simplified the process to help you make the right decision for your circumstances. This 3-step process includes:
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Symptoms of Failed Implants
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
- Confusion
- Shortness of breath
- Migraines
- Itching
- Nausea and dizziness
- Numbness in the extremities
- Issues with vision
- Weight gain
- Heart palpitations
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.
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Medtronic lawsuits allege the manufacturer illegally promoted the Medtronic bone product for off-label use in certain surgeries. If you or a loved one have questions about the MEDTRONIC INFUSE BONE GRAFT, call your local products liability attorneys, THE RUTH LAW TEAM, at (888) 783-8378.
