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Breast Implant Injuries-Manufacturer’s Negligence

With more than 400,000 women choosing to undergo breast implant surgery each year, mainly for enlargement purposes and some for reconstruction after cancer surgery, there are growing concerns of a rare type of cancer called BIA-ALCL. According to the World Health Organization (WHO), BIA-ALCL, or Breast Implant-Associated Anaplastic Large Cell Lymphoma, is a T-cell lymphoma that can develop after breast implants. BIA-ALCL is not a breast cancer, but rather a type of immune system cancer found near the implant in the fluid and scar tissue. If not treated early on, there is a greater chance that the lymphoma can spread throughout the body.

As of September 2018, the U.S. Food and Drug Administration (FDA) received over 414 reports of BIA-ACLC, including nine unfortunate deaths of patients. The data shows that the majority of the reports attributed to textured implant surfaces and silicone implants as opposed to smooth surfaces and saline implants.

Overall, breast implants have been known to involve many different types of injuries and mechanisms. Some cases have reported multiple injuries stemming from the same implant. More commonly, symptoms may not appear until a considerable time following the procedure. The FDA has a list of a few breast implant complications and adverse outcomes:

  • Rupture near implant’s outer shell
  • Lymphedema, or swollen lymph nodes
  • Infection, including toxic shock syndrome
  • Breast pain
  • Wrinkling/Rippling of the implant
  • Skin rashes
  • Seroma
  • Necrosis
  • Latrogenic Injury

When injuries occur, an injured patient may have a personal injury claim against the plastic surgeon, the manufacturer, or both, depending on several factors surrounding the circumstances. If the injured patient chooses to seek a claim against the manufacturer, the underlying theory of liability will likely be negligence. negligence of the breast implant manufacturer may be predicated upon defects in the design, manufacture, construction, or testing of the implant, or in the manufacturer’s failure to adequately warn of a known or knowable danger or risk in the use of the implant.

If a negligence claim is pursued against the manufacturer, the Plaintiff will need to prove that the defendant manufacturer was charged with a legal duty to conform to particular industry standards of care in the design, manufacture, construction, testing, warning, or labeling of its implant; the manufacturer failed to conform to the standard of care causing a defective breast implant; the manufacturer’s failure to conform and defective implant proximately caused the injuries sustained by the Plaintiff; and lastly, the Plaintiff suffered actual damages.

With respect to silicone breast implants, there are no federal, state, or municipal codification or regulations indicating the industry standard which must be followed by breast implant manufacturers in the production of their breast implants. This makes it difficult to establish that the manufacturer deviated from the applicable standard of care in a negligence case of this nature. Evidence of the applicable standard of care will often come in the form of expert testimony from a product designer, manufacturer expert, or design physicists employed by the manufacturer to discuss industry “custom and practice” at the time in question. A skilled attorney will put on expert testimony to discuss how the manufacturer deviated in some way from industry standards. For example, if the industry custom and practice required an implant mold to be dipped a specific number of times in silicone elastomer composition to ensure thickness, but evidence can be shown that the defendant manufacturer failed to comply with the elastomer thickness practice, this would constitute a deviation from industry standards of care.

Some arguments assert that implant manufacturers owe implant patients a duty to prevent or significantly curtail gel bleed by designing a thicker, less permeable elastomer by multiple dippings in the elastomer composition during the manufacturing process. In a recurring scenario, defective design and manufacturing of the silicone implant resulted in ruptures following the implant procedure. When the implant ruptures it causes silicone gel to escape past the protective elastomer and into the surrounding tissue. This was the case in Johnson v. Medical Engineering Corp., where a rupture of the Plaintiff’s gel-filled silicone implant was attributed to the manufacturer’s defective design and manufacturing. In the jury in Johnson awarded the Plaintiff a verdict of $25 million, a record-breaking verdict in U.S. history.

In other cases, the manufacturer may be liable for negligence under the theory that the manufacturer failed to provide adequate warnings of the risks and dangers attending the use of the implant. With breast implants, the warnings are often contained in the package insert prepared by the manufacturer when it is shipped to the plastic surgeon. In these sorts of cases, the manufacturer is required to warn the surgeon and not the patient because the surgeon is in a better position to assess the risks of the product and procedure against the health of the particular patient. Under the “learned intermediary doctrine,” the surgeon is obligated to impart the warning to the patient as part of the procedure for obtaining informed consent from the patient. However, if it can be shown that the manufacturer’s warnings to the surgeon were inadequate and the patient is injured as a result, liability may be imposed on the manufacturer for their failure to provide adequate warnings.

In Toole v. McClintock, the plastic surgeon was absolved from liability in the performance of a closed capsulotomy procedure. The Plaintiff suffered from pain and hardening in her breast and subsequently consulted a plastic surgeon. The surgeon found debris of silicone gel and elastomer shreds in each of her breast following a mammoplasty procedure she had undergone six years prior. As a result, the surgeon urged the Plaintiff to undergo closed capsulotomy to remove the silicone. The Plaintiff alleged that the manufacturer failed to adequately warn about the risk of rupture of its gel-filled implant during a closed capsulotomy procedure. Expert testimony determined that the package insert provided by the manufacturer to the surgeon did not adequately warn of the danger of rupture resulting from a closed capsulotomy. Since the surgeon had no way of knowing of its fragile nature and vulnerability to rupture before performing the procedure, the jury did not find the surgeon liable. The jury did, however, find the manufacturer liable. Breast implant cases against the manufacturer require a lot of skill and care. Contact the experienced personal injury lawyers at Rosensteel Fleishman, PLLC if you or a loved one have suffered injuries related to breast implantation. There is no fee for the initial consultation.

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