Breast implant litigation represents one of the longest-running areas of medical device lawsuits in the United States. From the silicone gel implant controversies of the 1990s to current litigation over textured implants linked to cancer, thousands of women have pursued legal claims against implant manufacturers for injuries ranging from local complications to systemic illness.
Types of Breast Implant Claims
Current breast implant litigation focuses on several distinct injury categories, each with different legal theories and evidentiary requirements:
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) represents the most serious complication forming the basis of modern implant litigation. This rare cancer develops in the scar tissue surrounding textured breast implants, particularly those manufactured by Allergan. The FDA issued recalls and warnings, and women diagnosed with BIA-ALCL after receiving textured implants have strong legal claims.
Capsular contracture occurs when scar tissue around an implant tightens and hardens, causing pain, distortion, and often requiring surgical revision or removal. While capsular contracture is a known risk, claims may arise when manufacturers allegedly failed to disclose accurate rates or when specific products show higher-than-expected contracture rates.
Breast Implant Illness (BII) describes a constellation of systemic symptoms some women report after receiving breast implants, including fatigue, cognitive difficulties, joint pain, and autoimmune-like symptoms. While BII remains medically controversial, some lawsuits allege manufacturers failed to adequately research and warn about potential systemic effects.
Rupture and gel bleed claims involve implants that break, leak, or allow silicone to migrate through the shell. Modern cohesive gel implants are less prone to migration than earlier designs, but ruptures still occur and may require surgical intervention.
Key Legal Theories in Implant Cases
Breast implant lawsuits typically proceed under several legal theories that plaintiffs must prove to recover compensation:
Failure to warn claims allege that manufacturers knew or should have known about specific risks but failed to adequately disclose them to surgeons and patients. Evidence that companies possessed internal safety data showing elevated complication rates that was not reflected in product labeling strengthens these claims.
Design defect claims argue that the implant's design is inherently dangerous, even when manufactured correctly. Textured implant litigation relies heavily on design defect theories, arguing that the texturing surface itself creates unacceptable cancer risk.
Manufacturing defect claims apply when specific implants deviate from their intended design due to production errors, quality control failures, or contamination during manufacturing.
The Allergan Textured Implant Recall
In July 2019, the FDA requested that Allergan voluntarily recall its Biocell textured breast implants after data showed these products were linked to the majority of reported BIA-ALCL cases worldwide. This recall affected implants sold under the Natrelle brand and tissue expanders used in breast reconstruction.
Women who received Allergan textured implants and subsequently developed BIA-ALCL, required implant removal due to cancer concerns, or experienced other serious complications may have viable legal claims. The recall itself provides powerful evidence that the manufacturer acknowledged safety problems with its product design.
Compensation in Breast Implant Cases
Women injured by defective breast implants may recover several categories of damages:
Medical expenses including explant surgery, cancer treatment if BIA-ALCL developed, revision procedures, and ongoing monitoring costs.
Lost wages for time missed from work during treatment and recovery.
Pain and suffering compensation for physical discomfort, emotional distress, anxiety, and diminished quality of life.
Disfigurement damages for visible scarring or changes to breast appearance following complications and corrective surgery.
Building a Strong Implant Claim
Successful breast implant claims require comprehensive documentation connecting the specific implant product to the injuries suffered:
Implant identification through operative reports, device registration cards, and manufacturer records establishing exactly which implants you received, including lot numbers and serial numbers.
Medical records documenting complications, diagnostic testing, treatment received, and physician opinions about the cause of your injuries.
Explant pathology if implants were removed, laboratory analysis of the implant and surrounding tissue can provide evidence of defects or disease.
Women considering breast implant litigation should consult with attorneys experienced in medical device cases who can evaluate claim strength and navigate the complex litigation landscape.