Allergan Breast Implant RecallBreast Implant Illness FDA Issued Statement

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Shamis & Gentile, P.A. Breast Implant Illness Lawyers are investigating litigation on behalf of individuals with recalled breast implants.  On July 24, 2019 The U.S. Food and Drug Administration (FDA) issued a recall of breast implants produced by pharmaceutical company Allergan, citing an increased risk of cancer among patients with implants manufactured by the company.

The FDA found that people with Allergan BIOCELL textured breast implants had an increased risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Symptoms of the rare form of cancer include swelling and pain around the implant.

FDA Issued Statement

“Once the evidence indicated that Allergan’s product appeared to be directly linked to significant patient harm… the FDA took action to alert the firm to new evidence and that the recall is warranted,” FDA Principal Deputy Commissioner Amy Abernethy told journalists.

Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including:

  • Natrelle Saline-Filled breast implants
  • Natrelle Silicone-Filled breast implants
  • Natrelle Inspira Silicone-Filled breast implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants

The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including:

  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs.

Allergan has stated that they will comply with the new recall order and stop the sale of BIOCELL saline-filled and silicone-filled implants worldwide. But Allergan is facing lawsuits from consumers who claim the corporation knew about the link between their products and BIA-ALCL as early as the 1990s but continued to sell and promote their products without informing the public of health risks posed by the implants.

Controversy: Autoimmune, Connective Tissue Disease, and Breast Implant Illness

The greatest controversy regarding the risks of breast implants concerns the question of whether they increase the risk of autoimmune disease and connective tissue disease. This issue has gained more recent attention now that it is clear that implants can cause ALCL, a cancer of the immune system.  If implants can cause cancer of the immune system, does that mean implants can cause other immune disorders?

More than 50,000 women have joined two Facebook groups of women who say their breast implants cause symptoms that they refer to as “breast implant illness.” Doctors classify many of the symptoms they are reporting as connective tissue or autoimmune symptoms, but in many cases the women are not diagnosed with a specific autoimmune or connective tissue disorder (CTD).

Nevertheless, plastic surgeons and implant manufacturers have consistently claimed that there is “no evidence” that breast implants cause autoimmune or connective tissue problems.  Scientific research has determined that these claims of “no evidence” are inaccurate.

Breast Implant Illness Linked to Textured Breast Implants

The FDA has been studying the risks associated with textured implants for years. In March, they held two days of hearings with testimonies from women who alleged that they had developed cancer as a result of their implants. Women reported symptoms including:

  • chronic fatigue
  • hair loss
  • intestinal issues
  • unexplained rashes
  • itching

The risk of developing BIA-ALCL was about six times higher for patients with Allergan BIOCELL textured implants than it was for patients with textured implants from other manufacturers. Patients with implants from cosmetic surgery and those who receive them during post-mastectomy reconstruction both appear to be at risk to develop the condition.

Do I have a Breast Implant Lawsuit?

Contact us for a free, no obligation legal consultation. If your case is not one that can be immediately signed up for representation we would still like to keep you involved and updated with any relevant new legal information that may be of your benefit in this very new area of litigation.  It is our intention to investigate all legal remedies for all women suffering from Breast Implant Illness (BII), regardless of the model of implant, as more details emerge.

Breast Implant Illness Lawyers | Contact Shamis & Gentile, P.A.

Contact the Breast Implant Illness Lawyers at Shamis & Gentile, P.A. today if you believe you have a breast implant induced injury case. If you or somebody you know has been diagnosed with side effects of silicone breast implants, you should contact our Breast Implant Illness Lawyers immediately for a free case consultation. Please fill out a form to contact our Defective Medical Device Litigation Group. Call us at 305-479-2299 or Text Us About It at 1-833-3-TEXT-ME (1-833-383-9863).

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