Allergan Breast Implants
Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company claims it has the No. 1 plastic surgery portfolio. In July 2019, the company issued a worldwide recall of its textured implants after the Food and Drug Administration linked the devices to a rare cancer.
Allergan Inc. is one of the largest breast implant manufacturers in the world. The company started selling breast implants in 2006 and now sells its products in more than 60 countries, according to market research company Technavio.
Its biggest sales are in the United States, Canada and Latin America. In 2018, Allergan’s breast implant division made $263 million in the United States, an increase from $242.6 million in 2017, according to its annual report.
Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan.
Allergan Breast Implant Brands and Models
- Biocell textured saline and silicone-filled implants and tissue expanders
- Natrelle Inspira Smooth Round Gel Implants
- Natrelle Inspira Textured Round Gel Implants
- Natrelle 410 Anatomical Gel Implants
- Natrelle Saline-Filled Smooth Round Implants
- Natrelle Saline-Filled Textured Implants
- Natrelle 133 Tissue Expanders
- Natrelle 133Plus Tissue Expanders
- Various McGhan breast implants and tissue expanders
- Various Inamed breast Implants and tissue expanders
Allergan’s products are popular among surgeons, but health regulators have linked its textured implants to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma.
In July 2019, the FDA requested Allergan voluntarily recall its textured breast implants after data linked the devices to hundreds of cancer cases and a dozen deaths. The company issued a worldwide recall.
What Are Implants Made Of?
Allergan breast implants have an outer shell of silicone elastomer, a type of silicone that has elastic properties similar to rubber. These shells can be filled with silicone gel or sterile saline, which is a saltwater solution.
Women can chose between Allergan’s anatomical, tear-drop shaped implants designed to mimic the curve of a natural breast or round implants with a full, round look.
In addition to implants, Allergan also makes tissues expanders used in reconstruction surgery. Doctors or nurses slowly fill expanders with saline over several weeks or months to stretch skin and muscle to make a pocket for a more permanent implant. Allergan’s Natrelle 133 Tissue Expanders are made of a silicone shell and textured surface to keep them from moving.
What Is the Difference Between Smooth and Textured Implants?
Implant shells may be smooth or textured. Smooth shells allow the implant to move under the skin or muscle, mimicking the movement of natural breast tissue. Most implants are smooth.
Textured shells allow tissue to grow into the surface of the implant and keep it in place.
Allergan manufactured smooth and textured implants until the FDA found the company’s Biocell textured implants had a higher risk of breast implant-associated anaplastic large cell lymphoma. On July 24, 2019, Allergan announced a worldwide recall of its textured implants and advised surgeons not to use them.
Some patients who used Allergan’s textured implants and developed cancer filed lawsuits against the company.
How Is Cup Size Determined?
Women who want a larger cup size will generally require a larger implant. Breast implant sizes don’t correspond to bra cup sizes because the size and shape of the woman’s chest determines the actual cup size.
Instead, Allergan measures its implants by the height and width of the implant, the distance the implant projects from a woman’s body and the amount of silicone or saline it contains in cubic centimeters, or cc.
Implants that contain more filler have a higher cc. For example, Natrelle silicone breast implants range from 80cc for smaller implants to 800cc for the largest size. The surgeon can determine whether there is enough tissue to cover the implant.
When it comes to implants, larger isn’t always better. Sometimes, the implant’s edges may be visible after the operation if there isn’t enough skin to cover it. Large implants may also pull down on the skin, causing breasts to sag earlier.
Allergan’s studies showed some complications were more likely to occur in women with larger implant sizes, according to their Breast Augmentation With Natrelle Silicone-Filled Breast Implants and Natrelle Inspira Breast Implants brochure.
Allergan Breast Augmentation Surgery
Primary augmentation refers to the first surgery someone has to increase breast size. Breast augmentation is an outpatient procedure that uses general anesthesia. The operation may take anywhere from one hour to several hours depending on the patient and implant.
For example, if a patient has a lot of excess skin, the surgeon may also perform a breast lift at the same time as placing the implant.
Textured implants may require larger incisions because rougher surfaces may make it difficult to slide the implant into the breast pocket. Silicone implants may also require larger incisions than saline implants.
In general, Allergan’s data shows most patients who provided a satisfaction rating 10 years after their surgery were satisfied with their results.
Out of 455 primary augmentation patients in Allergan’s Core Study, 279 provided a satisfaction rating. Eighty-six percent reported they were “definitely satisfied” with their implants.
There are two ways a doctor may place the Natrelle implant: submuscular and subglandular.
Submuscular implant placement means the surgeon places the implant under the chest muscle. This technique can reduce the risk of capsular contracture, which occurs when scar tissue squeezes the implant. Capsular contracture causes pain and hard, misshapen breasts, and puts women at risk for implant rupture.
Placing the implant under the chest muscle also makes breast tissue easier to see in mammograms and is preferred in women with weakened or thin breast tissue. However, surgery and recovery are longer and may be more painful. Reoperation may also be more difficult.
Subglandular implant placement means the surgeon places the implant on top of the muscle and under the breast glands. This method has a greater likelihood of capsular contracture and makes it more difficult to see breast tissue in mammograms.
Women with thin or weakened breast tissue might not do well with this surgery. But in general, the surgery and recovery may be shorter and less painful. It is also easier to perform revision surgery on these implants.
There are three common incision sites for Allergan silicone implants: periareolar, inframammary, and axillary or transaxillary.
Location: Around the nipple
Pros: More concealed
Cons: Higher likelihood of breastfeeding problems, higher risk of change in sensation in nipple, higher risk of infection
Location: In the breast fold
Pros: Fewer breastfeeding difficulties, best access and control of implant pocket, most commonly used by surgeons
Cons: Less concealed
Location: Under the arm
Pros: Fewer breastfeeding problems
Cons: Less concealed, more difficult, may increase risk of damage to and unexpected location of implant
Women generally feel tired and sore for several days following the operation. As the skin adjusts to the implant, there may be discomfort and tightness. Swelling can decrease feeling in the nipple and breast after surgery.
While women may be able to return to work within a few days of surgery, they should not do anything strenuous. Recovery may involve using a special bra or other support to help speed up healing. Some women may need pain medication infusion devices.
Reconstruction Surgery with Allergan Breast Implants
Women who have lost tissue because of mastectomy or trauma may also use Allergan’s Natrelle implants for immediate reconstruction surgery or delayed reconstruction surgery. In the case of immediate reconstruction, surgeons will perform the mastectomy and put in the breast implant at the same time.
Delayed reconstruction requires another operation but gives the woman time to evaluate the cancer risk. Some women may require more treatment after mastectomy. In general, it provides time to heal and get healthier for another surgery.
Surgeons typically perform reconstruction surgery in two stages. First, surgeons place a tissue expander in the chest to stretch skin and muscle and create a breast pocket. It usually takes four to six months to create a pocket. Then, the surgeon removes the expander and places the implant in the pocket created by the expander.
Complications and Safety Precautions
Like any surgery, breast augmentation has its risks. The FDA classified breast implants as class III, high-risk devices.
Women with breast implants will require monitoring and care for the rest of their lives to detect possible implant ruptures. This requires an MRI every two years the implant remains in the body.
If an implant is removed and not replaced, undesirable changes to the breast may be permanent and may include dimpling, puckering or wrinkling. Women who wish to nurse should know that breast implants can affect a woman’s ability to breastfeed.
Women should tell all health care providers who treat them about their implants to reduce the risk of damaging the implant.
“Breast implants are not lifetime devices, and not necessarily a one-time surgery.”
Because of these risks, Allergan requires surgeons and patients to sign Allergan’s “Acceptance of Risk and Consent to Surgery” form before breast implant surgery. The company also recommends women wait one or two weeks and think about whether breast augmentation is something they truly wish to do.
Key complications in studies included:
- Implant removal with or without replacement
- Implant rupture with silicone-filled implants
- Implant deflation with saline-filled implants
- Severe capsular contracture (scar tissue squeezes implant)
- Nipple, breast, skin sensation changes
- Wrinkling/rippling (folds of implant are visible through skin)
To study implant safety and effectiveness, Allergan conducted the Allergan Core Study, a 10-year study consisting of 715 patients. Of those patients, 455 had primary augmentation, 147 had revision-augmentation, 98 had primary reconstruction and 15 had revision-reconstruction.
Allergan found 49 percent of primary augmentation patients and 64 percent of revision-augmentation patients will have at least one complication within 10 years of surgery, including reoperation.
“Breast implants are not lifetime devices, and not necessarily a one-time surgery,” Allergan wrote in its Breast Augmentation With Natrelle Silicone-Filled Breast Implants and Natrelle Inspira Breast Implants brochure.
Other complications that occurred during Allergan’s study included: implant malposition, nipple complications, abnormal scarring, breast pain, swelling, fluid accumulation, hematoma and delayed wound healing.
Before Getting Implants
Natrelle breast implants aren’t for everyone. There are a few things to know before getting breast implants, according to Allergan. Some conditions may increase the risks associated with breast implant surgery.
Women should tell their doctors if they:
- Have an autoimmune disease or a weakened immune system
- Have any chemotherapy or radiation planned
- Have conditions or take medications that interfere with blood clotting or wound healing
- Have mental health disorders
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