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Dow Corning Breast Implants

The Dow Corning implants have been taken off the market for many years. These implants were considered the standard of care back in the 60’s and 70’s; however, over time, they were removed due to concern for autoimmune disease and breast cancer as well as increased risk of rupture. We remove patients’ Dow Corning implants every year. These implants are associated with usually a smooth shell and a patch posteriorly. It has been noted that approximately two million women have had the Dow Corning silicone implants placed since the early 70’s. In general, the Dow Corning implants are made of silicone which is silica, the most common substance on the earth, constituent of pure crystalline silica as it is silica which in its purest form can be found in sand, petrified wood, amethyst, agate and flint.

Silicon dioxide is associated with silicone atoms linked to oxygen in a 2:1 ratio. Human exposure to crystalline silica generally has no ill-effects on the body. Silicone has also been found to be non-toxic in amorphous form. The chronology of the Dow Corning silicone implants included multiple legal actions including a 1984 Stern v. Dow Corning, San Francisco as well as FDA classifying implants to Class III in June 1988. Programs on dangers of silicone implants on CBC, Face-to-Face, Connie Chung, multiple congressional hearings, including 1990, 1991 and then 1994 the class action suit finalized and manufacturers of Dow Corning being the largest contributor. In 1995, Dow Corning filed for Chapter 11 bankruptcy facing over 20,000 legal suits, over 410,000 potential claims that had been filed in a global settlement. In July 1998, claimants agreed to Dow Corning’s offer of $3.2 billion that settled tens of thousands of claims of injury from silicone breast implants. This agreement allowed claimants to receive money within a year and allowed Dow Corning to emerge from bankruptcy. The silicone implant information stems from silicone implants introduction in 1962, surgically implanted over 2.5 million American women worldwide. The original statement of Dow Corning Chemical in 1940 that silicone is biologically inert and non-toxic is based on a single one-week study of rats and ginny pigs, Dow Corning research study the effects of silicone chemical warfare and riot control in 1969, silicone gel is not a single substance, but is comprised of numerous types of silicone, referred to as a silicone chemical soup and that silicone has contaminants which may bleed through the surrounding implant and its neighboring tissue to have potential for possible significant toxicity as seen in the seminars over arthritis and rheumatology in 1994.

In 1995, the UCLA School of Medicine researchers determined that implants will likely rupture and they will leak within 10 years of placement of the Dow Corning implant. Interestingly, out of 217 silicone implants removed in a four-year period it has been concluded that there was approximately 40% fail rate and 95% fail rate within 12 years of the Dow Corning implants. They found complications that would further require surgery within five years, 27% of women underwent 450 implant-related surgeries and 79% of the surgeries were needed to address complication mostly associated with capsular contracture and scar tissue formation as found in the New England Journal of Medicine in 1997. The studies found that silicone will migrate through the body upon rupture and in 1956 it was found by Dow Chemical that researchers knew that the liquid silicone when injected into the body could migrate to other organs, including the heart, lung, brain and spleen. They also found silicone particulates as far away as a human finger joint and into the lymph nodes. In 1989, Dow Corning showed that silicone given only to rats increased the liver size up to 45% in weight. As a result, the Dow Corning implants were removed from the market completely.

In my own experience, we have removed Dow Corning implants, they have always shown rupture, minimal or no shell has been left over 15 to 20 years postoperative and found with severe silicone calcifications and silicone mastitis, hardened breast tissue requiring total open capsulectomies, removal of silicone implant and implant material and sometimes spreading to the axillary lymph node. We recommend all of our patients with Dow Corning implants to immediately have the implants removed as long as they are healthy enough to have this performed. MRI’s are really useful, however, not necessary if the patient is going to undergo surgery as all tissue will be sent to pathology for diagnostic purposes.

The below example shows the patient has 31-year-old ruptured silicone gel Dow Corning implants. As you can see the implant material is being removed through the inframammary incision. Subsequently, you can now see in the cavity that the tissue surrounding the implant was severe, hard, chalk-like calcified granulomas, thick and hard as a Baker IV capsule. The next photograph shows the capsule has all been completely exenterated and removed and the scar tissue is laid out nicely. The patient will furthermore be reconstructed with high profile silicone cohesive gel implants from Natrelle Allergan Pharmaceuticals. Our patients shall require MRI’s every two to three years to investigate and determine whether there is a positive Linguini sign or a rupture of the silicone shell bag. They should also undergo clinical breast exams monthly and mammography as necessary.

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