Context:
As new research on breast implants is discrediting accusations linking the devices to immune system disease, older accusations are being recycled that Dow Corning failed to disclose the complications involved with breast implants and breast surgery until "forced" to do so as a result of an unfavorable 1984 legal verdict. As a result, the critics maintain, women did not have sufficient information to make an informed decision.
Summary:
In fact, Dow Corning's disclosures to surgeons on breast implant complications track with information on the devices published in the medical literature. The company disclosed the evolving information on breast implant surgical procedures and potential complications to the medical community through vehicles like package inserts, data sheets, and surgical technique brochures. Like most medical device manufacturers, the company relied on patient information being conveyed through physicians. In fact, physicians strongly maintained that direct communication by the company to patients was inappropriate and potentially interfered with the doctor/patient relationship.
Excerpts from Dow Corning's Package Inserts and Information Sheets:
These excerpts show changes through the years in Dow's package inserts and information sheets concerning silicone breast implants.
The issue of 'Informed Consent' --whether or not women were informed of the risks or complications from silicone implants and how long they would last--is a central one in the implant controversy.
Dow Corning Cronin Technique for Implanting, Package Insert 1965
NOTE: Extensive laboratory and clinical studies have established that advantageous properties, limitations and surgical applications for medical-grade silicone elastomer implants. All synthetics, however, raise presently unanswerable questions with respect to the absolute safety of long term implantation in humans. Regarding the question of neoplasms in general implant situations. Brown states "We have not seen tumors in 100 clinical uses of synthetic materials, and the silicone and fluorocarbons have shown less tissue reaction than polyvinyl alcohol. The possibility of tumor formation around synthetic implants in animal experiments should be explained to patients in whom synthetic material is to be considered. The explantation should include the situation that these synthetics are so new that there has not been time to follow any such implants through a full human life-cycle. The advantage of synthetics possibly outweighs the inference that tumor formation in laboratory animals implies a significant risk of clinical use of medical-grade synthetics."
Dow Corning "Facts You Should Know About Your New Look", 1970-1975
Your physician has given you this booklet to help you understand the Mammary Prosthesis. There are probably countless questions you'd like answered about this surgical procedure. All of them can't possibly be covered here. But this booklet can give you a general picture of what's involved, drawn from the experience of doctors, clinicians and women who have had Mammary Prosthesis implantation.
Q. How long will the Mammary Prosthesis last?
A. Based upon laboratory findings, together with human experience to date, one would expect that the Mammary Prosthesis would last for a natural lifetime. However, since no Mammary Prosthesis has been implanted for a full life span, it is impossible to give an unequivocal answer.
Q. Can I expect any problems with my breasts following mammary augmentation?
A. While thousands of women have mammary augmentation operations done annually without any adverse reactions, no surgical procedure is a success every time, and each person's reactions to surgery and implantation can be different. Occasional complaints of excessive breast firmness and/or discomfort caused by fibrous capsule formation and shrinkage have necessitated surgical correction and have been noted in the medical literature.
Dow Corning package insert 1973
NOTICE IMPORTANT INFORMATION
This design of SILASTIC Round Mammary Prosthesis is new when compared to prior design. However, because of the thinner envelope design, this prosthesis is also somewhat more fragile than prior designs. It is especially important that the package insert provided with this device be read carefully and in its entirety. It is necessary that due care be exercised during the surgical procedure as to not rupture the prosthesis. A thorough study of the information provided and exercise of due care in handling this device should result in no problem for the surgeon. However, since Dow Corning realizes that accidental rupture of the device could occasionally occur, it is recommended that an extra pair of the same size prosthesis be available at the time of surgery. In addition, Dow Corning is presently maintaining a policy of no charge replacement of the prosthesis should it be accidentally ruptured by the surgeon during operative and surgical use...ruptured prostheses should be retained for replacement by your salesman.
Dow Corning Fact Sheet 1976
Fibrous Capsule Contracture
It has been recognized for many years that capsular contracture occurs in some augmentation mammoplasty patients. Hormones, gel "bleed", silica, dust, talc, surgical procedure, pocket size, fill levels, patient type, electrostatic charges, and many other suggestions have been offered as possible explanations for this phenomenon. No generally accepted explanation exists today. There is also no universally accepted method of preventing fibrous capsule contracture.
Gel-filled silicone implants slowly "bleed" minute quantities of silicone, which has been detected in the fibrous capsule. The presence of this silicone does not correlate with the clinical hardness of the capsule.
Dow Corning Suggested Surgical Procedure 1976, 1979, 1980
Adverse Reactions
While thousands of women have mammary augmentation operations done annually without any adverse reactions, no surgical procedure is a success every time, and each person's reactions to surgery and implantation can be different. Occasional complaints of excessive breast firmness and/or discomfort caused by fibrous capsule formation and shrinkage have necessitated surgical correction and have been noted in the medical literature.
An alternative to surgical release of a "tight" capsule is the closed compression technique for rupturing a contracted capsule around a breast implant.
Excerpt from "Instructions for use:"
5. Be certain that the patient understands that following implantation, abnormal squeezing or trauma to the breasts could conceivably rupture the implants.
Dow Corning "Facts You Should Know About Your New Look", 1977, 1978, 1979
Q. How long will the Mammary Prosthesis last?
A. Based upon laboratory findings, together with human experience to date, one would expect that the Mammary Prosthesis would last for a natural lifetime.
Dow Corning "Facts You Should Know About Your New Look", 1980
Q. How long will the implants last?
A. Based on laboratory findings and human experiences to date, a gel-filled breast implant should last for a lifetime. However, since gel-filled breast implants have been implanted since 1962, there is only approximately 20 years of actual experience. Saline-filled and gel-saline implants have been used for 10 years and 5 years respectively. These may or may not last as long as gel-filled implants. They may also leak and subsequently deflate.
Dow Corning package insert 1980
Excerpt from "Complications"
7. Capsule contracture
As noted in the medical literature, complaints of excess breast firmness and/or discomfort caused by fibrous capsule formation and shrinkage have necessitated surgical correction.
Dow Corning package insert 1983
Note
The medical literature indicates that the functional life of any implant may not exceed the lifetime of the patient. This should be explained to and understood by the patient, by the physician.
Complications:
11. Closed Capsulotomy
Closed capsulotomy may rupture mammary implants.
12. Calcification
Reports of calcium plaques on or surrounding mammary implants have been reported in a few cases. No evidence is presented in the literature to link the prosthesis with calcification.
13. Silicone migration
Closed capsulotomy procedures may rupture the implant and necessitate removal. Under severe force the envelope can rupture and silicone gel can be forced out of the implant into natural body planes.
The above mentioned reactions should be discussed with and understood by the patient prior to surgery.
Dow Corning package insert 1985
Possible Adverse Reactions and Complications
Thousands of women per year have had cosmetic or reconstructive surgery with implantation of mammary prostheses. A number of patients are reported to have significant complications or adverse reactions. Typically, any patient undergoing a surgical procedure is subject to unforeseen intra-operative and post-operative complications. Each patient's tolerance to surgery, medication and implantation of a foreign object may be different. Possible risks, adverse reactions and complications associated with surgery and the use of the mammary prosthesis should be discussed with and understood by the patient prior to surgery. The adverse reactions and complications most likely to occur with the use of this product are listed below. IT IS THE RESPONSIBILITY OF THE SURGEON TO PROVIDE THE PATIENT WITH THE APPROPRIATE INFORMATION PRIOR TO SURGERY.
1. Capsule Formation and Contracture
The post-operative formation of a fibrous tissue capsule around the mammary prosthesis is a normal physiologic response to the implantation of a foreign object. Capsule formation occurs in all patients. However, each patient capsule will vary in degree, ranging from thin and filmy to heavily thickened. Contracture of a fibrous capsule may occur, independent of its thickness, resulting in discomfort, pain, excessive breast firmness, a palpable prosthesis, and/or displacement of the prosthesis. The medical literature documents that correction may require intervention by the surgeon. In some patients, even with further surgery and treatment by the surgeon, firmness may recur. This possibility should be discussed with and understood by the patient prior to surgery.
Integrity of the envelope cannot be assured if the surgeon should choose to perform closed capsulotomy, i.e. if external force is used in manual compression of the breast, since unknown or abnormal force may be applied to the implant. Such abnormal trauma or stress to the breasts could result in prosthesis rupture and extravasation of gel into surrounding tissue.
2. Sensitization
There have been reports of suspected immunological sensitization or hyperimmune system response to silicone mammary implants. Symptoms claimed by the patients include localized inflammation and irritation at the implant area, fluid accumulation, rash, general malaise, sever joint pain, swelling of joints, weight loss, arthralgia, lymphadenopathy, alopecia, and rejection of the mammary prosthesis. Such claims suggest there may be a relationship between the silicone mammary implant and the reported symptoms.
Materials from which this prosthesis is fabricated have been shown in animal laboratory tests to have minimal sensitization potential. However, claims from clinical use of the silicone prosthesis in humans suggest that immunological responses or sensitization to a mammary prosthesis can occur. If sensitization is suspected and the response persists, removal of the prosthesis is recommended along with removal of the surrounding capsule tissue. This procedure is recommended along with removal of the surrounding capsule tissue. This procedure is recommended to minimize the amount of residual silicone that may be left at the implant site.
3. Implant Rupture and Gel Extravasation
Rupture of implants has been reported both intra- and post-operatively. Rupture may result from the following: intra- or post-surgical trauma; excessive stresses or manipulation as may be experienced during normal living experiences including routine and purposeful trauma as vigorous exercise, athletics and intimate physical contact; mechanical damage before or during surgery or other unknown causes at the site of implantation. Chronic flexing of the implant shell during use as may be experienced during the performance of routine manual massage or manual exercise of the implanted breast may also produce long term fatigue of the shell, resulting in rupture. If the surgeon should choose to perform manual compression of the breast (closed capsulotomy) he/she should be aware that it may lead to implant rupture due to weakening of the envelope from the continued and excessive forces the implant may experience. The patient should be adequately informed of the possibility of implant rupture with the use of this technique and of the necessity to remove a ruptured implant should that occur. Dow Corning is not responsible for the integrity of the implant should such techniques as closed capsulotomy (manual compression) be performed. Medical reports state more frequent intra-operative rupture occurs with the use of a small incision for introduction of the prosthesis, as in trans-axillary insertion, or in submuscular placement of a prosthesis. As reported in the literature, when an implant ruptures, gel may be released from the implant envelope despite the cohesive properties of the gel. If left in place, complications such as enlarged lymph nodes, scar formation, inflammation, silicone granulomas and nodule formation may result. Possible further migration of the silicone gel to other tissue as well as adjacent tissue may occur. A limited preliminary study has been reported to the medical community that in the presence of select bacterial infection at the site of a ruptured implant, extravasated gel may be altered by the bacteria with a resultant decrease in cohesivity of the gel. If true, there is greater potential for distant migration of the gel. In the event that a ruptured prosthesis is suspected, and especially if the area becomes infected, Dow Corning recommends removal of the envelope and gel. These potential consequences should be understood by the surgeon and explained to the patient prior to implantation.
Note:
Dow Corning's high performance medical-grade silicone elastomer has been used to fabricate the envelope of this implant. This material can be cut by a scalpel, penetrated by a needle, damaged or ruptured by excessive stress, intra-operative manipulation, or by instruments. The silicone gel within this product is formulated and cured to maintain cohesion and minimize migration of gel should the envelope rupture. In the event of a rupture, Dow Corning recommends prompt removal of the envelope and gel. The long term physiological effects of uncontained silicone gel are currently unknown. Since SILASTIC II Mammary Implant H.P. is composed of alloplastic materials, it is subject to possible reactions and complications as listed above. Therefore, the patient should not be lead to unrealistic expectations as to the performance or cosmetic results that the surgery and prosthesis can provide. The patient should be informed that the life expectancy of any implant is unpredictable.
15. Implant Gel Bleed
Gel bleed results from the passage of small quantities of silicone through the elastomer envelope of the implant. In vitro bleed tests demonstrate that this bleed phenomenon is significantly reduced in the SILASTIC II prosthesis. The detector of small quantities of silicone in the tissue adjacent to the intact, conventional gel-filled implant and in axillary lymph nodes has been reported in the medical literature. There is no evidence of metabolic products of this silicone bleed. Some cellular reaction around the implant may be expected as normal foreign body response.
16. X-ray Pre-Operative and Post-Operative
17. Calcification
Physicians have reported calcification of the tissue surrounding the implant. The etiology of calcification is unclear. In some instances, heavy calcification resulting in local discomfort and breast firmness may require removal of the implants and the calcified capsule.
18. Absorption of Biologicals by Implants
Selected breast prostheses examined after various lengths of implantation have undergone a change in the gel and envelope coloration to shades of yellow. Occasionally, the gel has been observed to contain particles that include material of varying size, texture, and coloration. Analysis have revealed many to contain triglycerides, lipids, or steroid-type materials. These are postulated to slowly move through the silicone elastomer shell from the surrounding tissues. The degree of such biologicals appears to be patient-specific.
