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Out of all cosmetic procedures, breast implants continue to remain the most popular – and have been the most requested for over the past decade. Yet, even as getting them seems more acceptable and safer, serious risks are still involved, including development of anaplastic large cell lymphoma (ALCL).

Yet, the FDA’s recent communication concerning this side effect is hardly the first time breast implants have gotten negative attention. While they’ve been an enhancement option since the 1960s, lawsuits involving their composition emerged in the 1990s, and even into the 2010s, patients continue to come forward after facing major health issues.

Background

Breast implants have been around since 1962, with silicone used for these earlier versions. But, because of the material’s risks, the FDA reclassified them in the 1980s as a Class III device, and banned them outright in 1992. Newer saline implants, on the other hand, were untouched.

What prompted the FDA’s decision? A study published at the time showed that as many as 69 percent of women with silicone implants experience rupture and require additional surgery. As a result of both this data and the FDA’s ban, about 19,000 women filed lawsuits against manufacturer Dow Corning. After paying a $3.2 billion settlement, the company filed for bankruptcy.

In 2011, the FDA found a possible link between certain types of breast implants and the development of ALCL, a rare form of non-Hodgkin’s lymphoma. Its database included, at the time, 60 related cases of ALCL, and while the FDA continued to research the association, they also required manufacturers Allergan and Mentor Corp. to update their warning labels to state this risk.

By February 2017, reports involving ALCL increased to 359, including nine deaths. Yet, out of this total, 203 concerned breast implants with a textured surface, divided between 186 silicone cases and 126 from saline. In analyzing this data, the FDA determined that women who receive textured breast implants have a risk of developing ALCL 67.6 times higher than women who don’t get implants.

However, the FDA lifted its ban on silicone implants in 2006, and other models, as a result, have entered the market. One was the Mentor MemoryGel, an implant found to leak a dangerous fluid. For this implant, Mentor used a solution made with chemicals and heavy metals both harmful to the body. After surgeons added the implants, the gel leaked out microscopically through its membrane, or the membrane itself would burst.

Recipients would then show signs of:

  • Lymphoma
  • Lupus
  • Fibromyalgia
  • Rheumatoid arthritis
  • Autoimmune diseases
  • Multiple sclerosis
  • Sjogren’s Disease
  • Raynaud’s Syndrome
  • Skin rash
  • Muscle pain, especially around the implant area
  • Extreme fatigue
  • Nausea

Lawsuits

Multiple plaintiffs have filed lawsuits against Mentor Worldwide and its parent company, Johnson & Johnson, alleging both failed to comply with FDA regulations. Specifically, for preapproval, Mentor agreed to conduct six studies concerning the MemoryGel, and to date, that information has yet to be submitted to the FDA. Furthermore, those who received the MemoryGel claim that Mentor failed to warn the FDA and medical professionals about the device’s extreme dangers.

However, Mentor isn’t the only manufacturer to come under fire. Plaintiffs have pursued Allergan, alleging the Natrelle silicone implants caused them neurological issues and vision loss. As well, certain recipients state the implant is associated with breast cancer and that Allergan enrolled them in a study without prior consent.

Lawsuits, as well, may involve the doctor who performed the procedure. If, for instance, the doctor had selected an implant without informing you of possible rupturing risks or had used a defective set, you could be dealing with a case of malpractice or medical negligence.