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Mentor’s Breast Implant “MemoryShape” Gets FDA Approval

July 1st, 2013 Miguel A. Delgado Jr, MD

San Francisco, CA-When the FDA called a moratorium on silicone breast implants in 1992, the road back to approval for these implants was very slow. The scare that the implants might be causing autoimmune diseases and various other complications made the implants unavailable to all except patients undergoing breast reconstruction surgery or breast augmentation revision surgery. That left women who wanted breast augmentation, saline breast implants as their only choice.

Mentor's MemoryShape Implant

Mentor’s MemoryShape Implant

 

After many clinical trials, silicone breast implants were deemed safe and returned to market in 2006 for women 22 years of age and older. The approval comes with the understanding that the FDA recommends (not requires) that women have an MRI after three years of implantation and then every two years after that. The MRI is to watch for what is referred to as “a silent leak”. Within just a few years, the popularity of silicone breast implants surpassed saline implants by 80%.

Conducting trials for breast implants is very challenging for manufacturers, surgeons, patients and the surgeon’s staff. Once the excitement of the surgery has worn off, it is difficult to keep patients that are not having any issues to come in for their yearly visits, even with incentives offered by the manufacturer. In many cases, the patient may have moved out of the area, or there may have been staff turnover in the surgeon’s office and compliance starts falling through the cracks, making consistent follow up for 5 to 10 years daunting.

In anticipation of future FDA approval for silicone breast implants, manufacturers continued to develop new types of implants and started to conduct clinical trials. The “gummy bear” which is a colloquial term to describe the firmer anatomical cohesive gel implant, had trials beginning in 2001.

The highly cohesive implant made by Mentor is called “MemoryShape” and has been available for the past 10 years in 70 countries but not in the United States, until now. The “MemoryShape” implant has a tapered “teardrop” shape. It is thinner at the top and gently slopes to a fuller projection at the bottom. The shell has a subtle imprint; “Siltex Texture” designed to keep the implant in place.

The appeal of the anatomical shaped cohesive breast implant for most women is for a more natural look, youthful firmness and due to the high cohesiveness, they are less likely to ripple, rupture or leak throughout the breast tissue.  For the downside, many women do not like the firmness or the risk of rotation of a teardrop shaped implant leaving them looking deformed.  Also, it is very difficult to insert the implant through an incision around the areola, the recommended approach is the inframammary fold  which requires a longer incision. The breast implant cost goes up by approximately $1000.  The anatomical shaped implant does not work well with  breast revision  surgeries or for the woman who desires larger and/or softer implants and for the woman having a breast reduction with a lift and implant, will most likely be happier with the standard gel implants.

Allergan got FDA approval for their “gummy bear” implant, Natrelle 410 in February 2013, and Sientra got approval for their anatomical cohesive gel implant in March 2012.  Mentor is the only company that manufactures their implants in the United States, but all implants available in the United States are manufactured with the same strict guidelines.

Mentor LogoThe anatomical cohesive gel breast implants vary in; their firmness, their shape and dimensions. They all have a textured shell to help the implant from moving out of place or rotating. The different manufacturers made their implants with different degrees of cohesiveness and they vary on how much gel they put into the shell. The more cohesive the gel is and the more they fill the shell, the better it will hold its shape, and is more resistant to shell folds, but will not feel as soft.

Since FDA approval of silicone gel breast implants in 2006, women have many more choices. There is fierce competition amongst breast implant manufacturers. Each manufacturer has its own philosophy for advantages and disadvantages for the different possible aspects of breast implants.

In deciding to have breast augmentation surgery, the patient needs to review all risks and possible complications with her surgeon and understand that implants are not lifetime devices. It is important to be aware of the fact that revision surgery will most likely be necessary at least once in a patient’s lifetime, and maybe more.

Surgeons have their own preferences and experiences with different implants. It is more important to find a Board Certified Plastic Surgeon that you trust, to help you determine what type of implant is best for you. Be sure to request to see many pictures, before and after breast implants.

Can Breast Implants be Removed Permanently?

January 15th, 2013 Miguel A. Delgado Jr, MD

Bilateral Capsular Contracture

Over 5 million women have breast implants, nearly 400,000 women have breast augmentation surgery annually. There are about 40,000 women a year that have their breast implants removed permanently, there are several reasons women may decide to do this. They may have a rupture or deflation, financial concerns; they may be prone to capsular contracture or breast cancer, or maybe a change in lifestyle.

As with any surgery there are risks and complications, they may be left with loose skin, sagging breasts, infection, scarring, loss of sensation in the nipples, anesthesia complications.

Insurance may cover the removal if it is being done for a medical reason such as, infection, leakage or cancer. Removal of breast implants requires removal of the capsules to prevent them from filling with fluid.

When implants are removed, the breast is left with no volume and may be quite droopy. The skin may have lost its elasticity and not contract well if at all, looking somewhat like a deflated balloon. Many women opt to have a breast lift after implant removal.

I Need Breast Implant Revision Surgery but Don’t Know What Kind of Implants I Have, What Should I do?

September 13th, 2012 Miguel A. Delgado Jr, MD

Mentor I.D. Card

 

It is customary for your surgeon’s office to give you an I.D. card after breast augmentation surgery that contains breast implant information you may need in the future. Unfortunately for many San Francisco Bay Area women, as the years pass they may have lost their card. The best thing to do is to contact your surgeon’s office and see if they have a record of it. If your surgeon is no longer in practice, then try contacting the hospital or surgical facility where you had the procedure done. This should be done as soon as possible because records are not kept indefinitely. In California records only need to be kept for 7 years, but each state has its own requirements.

When having breast implant revision surgery, it is very helpful to the surgeon to know who the manufacturer of your breast implants is, and what type and size they are. In many cases, the manufacturer will cover the cost of the breast implants and provide compensation to the hospital or surgery center for part of the cost of the revision, if the reason for the revision is the failure of the breast implants.

How Long will Breast Implants Last?

July 6th, 2012 Miguel A. Delgado Jr, MD

Saline breast implant deflation

When contemplating breast augmentation surgery, many Marin County women ask how long breast implants will last. There is no way to know how, as it is different for everyone. There isn’t an expiration date on them. If you are not having a problem, they do not need to be replaced. You should be prepared to have breast revision surgery at least once in your life.

Basically all breast implants have the same design. They are made up of a silicone envelope and filled with either saline or silicone gel. Breast implants can develop a tear or hole. Ruptures or deflations can happen if there is a severe blow to the chest or aging of the implant. If implants are old, it is possible that they can rupture during a mammogram. Saline implants have a valve. If the valve is defective, or breaks, it will deflate.

Recent advancements for breast implants have made them safer and longer lasting than ever. Breast implant manufacturers stand behind their products and give them a lifetime replacement warranty. They also extend a ten year warranty for reimbursement of some of the surgical costs, if breast revision surgery becomes necessary.

What You Should Know About the PIP Breast Implant Scare

January 20th, 2012 Miguel A. Delgado Jr, MD

There have been a lot of reports in the news lately about a French manufacturer of defective breast implants used for breast augmentation surgery. It was discovered that Poly Implant Prothese (PIP) a now defunct company had been using industrial grade silicone instead of the more expensive medical grade for their silicone implants. According to Wikipedia, industrial grade is only 10% of the cost of medical grade.

In 1996, PIP was selling their saline implants in the United States including the San Francisco Bay Area, but saline and silicone implants were distributed to many countries worldwide. All silicone implants were banned in the United States from 1992-2006 due to health concerns but reintroduced after extensive testing proved them to be safe. Only two breast implant companies are approved by the FDA, Mentor and Allergan. 

PIP became the third largest breast implant company in the world before being shut down in 2010 when the discovery was made. A Dutch company rebranded the implants with the name Rofil M-implants, and is also at risk as the contents are the same.  In 2000 the FDA sent an inspector to the PIP manufacturing company and found many substandard practices thereby banning all PIP implants for the United States.

The American Society for Aesthetic Plastic Surgery (ASAPS) recommends women have the implants removed due to the high rupture rate and also due to the fact that the adverse effects of the impurities used in industrial grade silicone are unknown. The International Society of Aesthetic Plastic Surgery (ISAPS) supports this recommendation. Different countries have different recommendations. Several countries recommending removal besides the United States are; France, Germany, Venezuela and the Czech Republic. Some countries are setting up registries and hotlines but not recommending removal at this time.

Dr. Delgado recommends that women who have had breast augmentation surgery outside of the United States to get in touch with their surgeon to verify what type of implants they have.  Dr. Delgado also stresses the importance of all women to know the brand, size of their implants and if they are saline or silicone.

For a limited time, Dr. Delgado is offering a reduction in surgical fees to San Francisco Bay Area women who wish to have their PIP implants removed. For more information please contact the office.