Breast Implant Injury Lawsuits

For decades, women have experienced various injuries and health conditions associated with breast implants, but many of the risks posed by breast implants have not been adequately addressed by the medical and regulatory communities. Now, complications linked to breast implants have led to voluntary recalls and new warnings from the Food and Drug Administration (FDA). The FDA recently requested that Allergan recall its BIOCELL textured breast implants and tissue expanders following reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) linked to these devices. The FDA has also begun to reevaluate reports of joint pain, fatigue, autoimmune disorders, and localized pain and swelling by women with implants and ruptured implants. The FDA has also provided certain labeling recommendations, including a black box warning.

Breast Implant Injury Lawyers are Ready to Help

Contact our Breast Implant Injury Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Breast Implant Injury cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Breast Implant Injury Lawyers at our law firm, please call (800) 315-3806 or submit an email inquiry.

What is Breast Implant Injury?

Breast implants can be filled with either saline or silicone gel. Both types of implants have a silicone shell. While significant differences in the safety of each type of implant have not been reported, each type of implant carries its own risks. A saline implant rupture is easily detectable when the breast shape rapidly changes as salt water seeps out. A silicone gel rupture is often difficult to detect. Silicone can leak out of the implant and remain in the body, often seeping into distant lymph nodes. Aside from injuries and surgery related to ruptured implants, certain implants have also been linked to a rare form of cancer and the onset of autoimmune diseases.

What is Happening with Breast Implant Injury?

As silicone breast implants became increasingly popular in the 1980’s, women reported adverse health conditions when the implants ruptured. The FDA restricted the use of silicone implants to women who required implants following a mastectomy, but later reversed that restriction in 2006 for certain silicone implants. However, many of the risks associated with silicone implants continued to plague patients despite the FDA’s decision to restore the sale of silicone implants. Several types of injuries have been associated with breast implants.
Recall of Allergan BIOCELL Textured Breast Implants and Tissue Expanders

The FDA warned consumers about the potential risks of breast implants including additional surgeries, capsular contracture (as a result of scar tissue), and rupture. More recently, Allergan, a leading manufacturer of textured implants, complied with the FDA’s request for a voluntary recall of its BIOCELL textured breast implants and tissue expanders. The recall was prompted by the discovery of a link between textured breast implants and a rare type of cancer known as anaplastic large-cell lymphoma (ALCL), a cancer of the lymphatic system. ALCL has been diagnosed in 573 women with breast implants worldwide. Of the 573 cases, 481 cases are linked to Allergan implants. Twelve deaths in women with Allergan breast implants have been confirmed. An association between the incidence of ALCL and breast implants (either saline or silicone) was first reported in 2011. In light of the discovery that the risk of ALCL was higher in women with textured implants than smooth implants, the FDA urged the recall of this specific textured model manufactured by Allergan.
Breast Implant Illness (BII)

The FDA recently issued warnings to two breast implant manufacturers (Sientra and Mentor Worldwide) regarding their failure to properly investigate the effects of breast implants on the long-term health of patients. Manufacturers were required to assess the health of women with implants over a period of several years as a condition of the agency’s consent to allow silicone implants to be reintroduced into the market in 2006. The Agency acknowledged that certain devices, such as breast implants, can cause harmful responses in the body, including inflammatory reactions and tissue changes leading to pain and discomfort. Women with breast implants have also reported fatigue, memory lapses, migraines, joint pain and autoimmune disorders (including rheumatoid arthritis, scleroderma, and Sjogren Syndrome). A report about the effects of silicone implants conducted at M.D. Anderson Cancer Center found that women with silicone implants had nearly an eight times increased risk of certain autoimmune diseases than the general population.
Breast Implant Rupture and Illness

Some of the health conditions reported by women with breast implants have been linked to rupture of silicone breast implants. A ruptured silicone implant can often occur “silently” and a woman may be unaware that silicone gel is leaking into other parts of her body until she experiences physical symptoms. Rupture can lead to a host of local ailments including pain, soreness and swelling of the breast, and lumps and hardening in the area. The FDA has stated that as many as one in five women seek removal of their implants within a decade of surgery due to rupture and capsular contracture. According to FDA adverse event data, the number of breast implant injuries from rupture and associated injuries increased from an average of fewer than 200 per year through 2016 to 4,567 events in 2017 and at least 8,242 events in 2018.

https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants

https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-two-breast-implant-manufacturers-failure-comply-post-approval-study

https://www.nytimes.com/2019/03/19/health/breast-implants-fda-illness.html

https://www.ncbi.nlm.nih.gov/pubmed/30222598

https://www.mayoclinic.org/healthy-lifestyle/womens-health/expert-answers/breast-implants/faq-20058454

Breast Implant Injury Side Effects and Complications

Breast implants are associated with both local and general injuries. The side effects and complications of breast implants include:

• Additional surgeries, including revision and removal;
• Capsular contracture (squeezing of the implant from scar tissue);
• Pain;
• Changes in sensation;
• Rupture (and spread of silicone);
• Lumps or hardening;
• Joint pain;
• Fatigue;
• Breast implant illness (BII);
• Autoimmune disorders; and
• Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Breast Implant Injury Lawyers are Ready to Help

Contact our Breast Implant Injury Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Breast Implant Injury cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Breast Implant Injury Lawyers at our law firm, please call (800) 315-3806 or submit an email inquiry.