In re Silicone Gel Breast Implants Products Liability Litigation Lawsuit

In re Silicone Gel Breast Implants Products Liability Litigation

• Type: Products liability mass tort (implants)

• Country: United States

• Court: U.S. District Court for the Northern District of Alabama

• Docket: MDL No. 926 (master file 2:92-cv-10000)

• Centralized / filed: June 25, 1992

• Resolved: 1998 (global settlement)

• MDL status: Terminated

Product and manufacturer

Silicone gel breast implants are prosthetic devices consisting of a flexible silicone elastomer shell filled with a cohesive silicone gel. They were used both for breast reconstruction, for example after mastectomy, and for cosmetic augmentation, and had been sold in the United States from the 1960s onward. Several companies manufactured and marketed the devices; the largest and most prominent defendant was Dow Corning Corporation, a Michigan-based joint venture formed in 1943 between The Dow Chemical Company and Corning Incorporated to develop silicone technology. Dow Corning was the world's leading silicone producer, and its implant line was the best-known of the devices at issue.

Alleged harm

Beginning in the mid-1980s, women who had received silicone gel breast implants reported a cluster of adverse health effects. The earliest claims focused on a possible connection between the implants and breast cancer. Over time, the theories advanced by the plaintiffs shifted toward a broader set of alleged systemic conditions: autoimmune and connective-tissue diseases such as lupus and rheumatoid arthritis, chronic fatigue, joint and muscle pain, and a range of neurological symptoms. The central allegation was that rupture or microscopic leakage of the silicone gel, or the device material itself, triggered these illnesses in susceptible patients. Tens of thousands of women eventually joined the suits.

Course of the litigation

Individual cases were first brought in 1984 in state and federal courts. The volume of filings led to a transfer of the federal cases into a single multidistrict proceeding: on June 25, 1992, the Judicial Panel on Multidistrict Litigation (JPML) centralized the federal breast implant actions as MDL No. 926, In re Silicone Gel Breast Implants Products Liability Litigation, in the U.S. District Court for the Northern District of Alabama, under master file number 2:92-cv-10000. The Panel selected Judge Sam C. Pointer, the former chief judge of that court, as the transferee judge, and more than twenty thousand cases were transferred to his docket. The threshold dispute in the MDL was whether silicone gel implants could cause the systemic diseases alleged, a question that turned heavily on competing medical and scientific expert testimony.

Bankruptcy and resolution

The litigation coincided with severe financial stress at Dow Corning. The company entered Chapter 11 bankruptcy in 1995, while the MDL was pending, and remained under bankruptcy protection until June 2004; during that period it largely withdrew from clinical and implant markets. In 1998, Dow Corning and the other implant defendants agreed to a global settlement that resolved the claims in the MDL. The settlement was administered by the Dow Corning Breast Implant Trust, a body established to process and pay eligible claims; the Trust continued paying claims into the 2010s. The final deadline for Dow Corning implant disease claims was June 3, 2019, after which no further claims of that type were accepted.

Post-litigation context

Scientific review in the years after the settlement did not support the systemic-disease theory. Independent assessments, including a review by the Institute of Medicine, concluded that silicone gel breast implants do not cause breast cancer or identifiable systemic disease. In 2017, the U.S. Food and Drug Administration separately reported that women with certain breast implants face a very low but increased risk of breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL), a rare lymphoma of the immune cells; the agency has since issued guidance on the associated risks and on explantation. This later finding is distinct from the conditions alleged in the MDL.