Breast Implant Litigation

Top officials of a major manufacturer of breast implants have recently confessed to knowing of the medical dangers related to breast implants for many years, yet, no warnings were ever provided. Breast implants have caused thousands of women to suffer serious physical injuries. As a result, hundreds of lawsuits have been filed throughout the country on behalf of the victims of breast implants. The purpose of this article is to discuss the background, available legal remedies, and general preparation necessary in a breast implant case.


Manufacturers of silicone breast implants began selling and marketing them in the 1960’s. At that time, the F.D.A. did not exist and the federal government did not regulate breast implant manufacturers in any way. After the Food, Drug and Cosmetics Act was passed in 1976, the F.D.A. did not regulate breast implant manufacturers because the law did not affect them since they were already on the market. Thus, the manufacturers did not have to provide any safety information to the government. As a consequence, breast implants were sold unchecked for many years.

Medical Ramifications

Substantial data exists indicating that silicone breast implants are responsible for causing many serious medical complications including, but not limited to breast cancer; liver cancer, as a result of a chemical reaction in the body caused by materials used in the implant sack; immune deficiencies; lumps throughout the body as a result of silicone leakage transferred through the lymphatic system to different parts of the body including, the neck, arms, legs, armpits; scleroderma, the toughening of the outer portion of the skin and sensitivity of the hands, fingers, toes and feet; lupus, accompanied by rashes, swollen glands, hair loss, kidney and lung damage; central nervous system disorders; and chronic arthritis. Further, an overwhelming majority of women that have breast implants suffer from capsular contracture which is the formation of hard fibers causing a type of scar tissue in the breast. As a result, the breasts become sensitive, painful, uneven in size and lumpy. Additionally, a risk exists that the silicone implant sacks may rupture. This would require surgical intervention to remove the sacks and replace them. Finally, detection of cancer causing lumps becomes difficult when a women has breast implants. The difficulty in diagnosing cancer increases the risk of breast cancer among implant patients.

State of the Art

Review of the medical literature and scientific data indicates that it has been suspected, if not known, since the late 1960’s and early 1970’s that the medical problems discussed above resulted from the use of silicone breast implants. Animal studies conducted in the late 1960’s showed that silicone caused cancer. Nevertheless, the manufacturers of breast implants did not warn the public of these risks. Some warnings were published starting in the late 1970’s and into the 1980’s, but the warnings were solely provided for the medical field and usually written in a way that the average person would not understand. Moreover, the risks were never fully disclosed.

Legal Theories

A trial lawyer interested in representing plaintiffs in breast implant cases will be able to file suit on traditional product liability theories such as negligence, strict liability and breach of warranty. The two (2) most popular theories of recovery to pursue are negligence and strict liability. The negligence claim should include failure to warn. Based on the available data, the potential defendants failed to provide the plaintiffs with sufficient warnings when medical and scientific information existed showing that silicone breast implants were hazardous. Nevertheless, breast implant companies continued to manufacture, market and sell the breast implants with impunity. Under both strict liability and negligence, the manufacturers, suppliers and sellers of a product have a duty to warn users of hazards and complications that may be encountered when using the company’s products. This duty required breast implant companies to adequately warn of the potential medical hazards associated with the product when the breast implant companies knew, or should have known, about the dangers. See Tampa Drug Co. v. Wait, 103 So.2d 603, 607 (Fla. 1958). Under strict liability law, you must identify the type of silicone breast implant used and allege that the defendant was in the business of producing, distributing and/or selling the product; that the product reached the consumer without substantial change in the condition when it left the defendant’s possession; that the product caused injury to the plaintiff, or was a substantial contributing cause of injury to the plaintiff; and that the product was defective or unreasonably dangerous. See West v. Caterpillar Tractor Corp., 336 So.2d 80 (Fla. 1976). The manufacturer of the breast implants had a duty to give a warning commensurate with the danger or possible consequence encountered when using the product. Wait, 103 So.2d at 609. The duty to warn is continuing in nature. Hobbley v. Sears Roebuck Co., 450 So.2d 332 (Fla. 1st DCA 1984). Under the failure to warn theory, claims for strict liability and negligence are valid even though the product may have been designed and manufactured properly, if the product is unreasonably dangerous due to a lack of warning or lack of an adequate warning to the ultimate user. Hobbley v. Sears Roebuck Co., 450 So.2d 332 (Fla. 1st DCA 1984); See also Borell v. Fiberboard Paper Products Corporation, 493 F.2d 1076 (5th Cir. 1973).

Expert Witnesses

The hiring of the appropriate types of expert witnesses in a breast implant case is very important. A trial lawyer handling a breast implant case will have to hire several different types of experts. Among them, a trial lawyer should consider retaining the following: Plastic Surgeon – to discuss how the implant works, where it is placed, and what surgical procedure is involved; Medical Internist – to discuss the medical ramifications and resulting damage caused by the breast implant; Oncologist – a cancer specialist that can identify the type of cancer that the plaintiff suffers from; Immunologist – to discuss immune deficiencies that may have been caused by the breast implant in question; Treating physician – whenever possible, the treating physician should be used to establish causation and damages. The plaintiff’s medical doctor should carefully explain to the jury how the breast implant hurt the plaintiff, the seriousness of the plaintiff’s disease, and the plaintiff’s prognosis; State of the Art Expert – One of the medical doctors should be qualified as a science/medical historian. The medical historian should be used in the breast implant case to establish the failure to warn case. This is accomplished by testifying about what medical and scientific information was available to the defendant at a given time and place, thereby proving the existence of the defendant’s duty to warn about the dangers associated with the breast implants. State of the art testimony is often dispositive of the failure to warn liability issue. In other words, once the medical and scientific literature mentions that there may be a hazard related to the defendant’s product, then the manufacturer had an affirmative duty to warn of the dangers. See Johns Manville Sales Corp. v. Janssens, 463 So.2d 242 (Fla. 1st DCA 1984); and Economist – If lost wages are involved, an economist should be called by the plaintiff’s attorney to discuss economic losses in the past and in the future.


Along with the standard documents used in a personal injury case, which include medical bills, medical records, mortality tables, models and photographs. Consumer complaints, previous lawsuits, federal regulatory agency reports and similar documents indicating a problem with breast implants should also be introduced into evidence to establish that the defendant knew, or should have known, that there was a problem with the breast implants at the time that it was implanted in the plaintiff. Demonstrative evidence should include a sample of the type of breast implant at issue, a model of human breasts, photographs of any surgery necessary to place the implant or remove the implant, and other traditional exhibits used in a general personal injury cases.


Many breast implant cases have been filed throughout the country. It seems that just about every personal injury firm represents at least one breast implant victim. It is important to properly prepare a breast implant case for trial. Breast implant cases are complex and require thorough planning, research, funding and dedication. A trial lawyer representing a breast implant victim should be prepared to “go the distance” so as to maximize the client’s potential to attain just compensation. Only lawyers that are willing to put in the time, money and effort to correctly work up these cases should handle them.